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Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01302834
Recruitment Status : Active, not recruiting
First Posted : February 24, 2011
Results First Posted : January 9, 2020
Last Update Posted : October 3, 2023
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Head and Neck Cancer
Precancerous Condition
Interventions Biological: cetuximab
Drug: cisplatin
Radiation: IMRT
Enrollment 987
Recruitment Details  
Pre-assignment Details Sites were required to submit participant tumor tissue for central p16 evaluation within one week of registration. If participants were determined to be p16-positive and continued on the study, then treatment arm was assigned. Of 987 participants registered, 849 were randomized.
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Period Title: Overall Study
Started 424 425
Eligible [1] 406 399
Started Treatment [2] 398 394
AE Assessed 1 Month Post-treatment (PT) [3] 369 363
AE Assessed 3 Months PT [4] 359 367
AE Assessed 6 Months PT [5] 361 352
AE Assessment 1 Year PT [6] 360 351
AE Assessed 2 Years PT [7] 311 303
AE Assessed 5 Years PT [8] 92 86
Dental Health Assessed 1 Year PT [9] 267 267
Dental Health Assessed 2 Years PT [10] 208 201
Dental Health Assessed 5 Years PT [11] 44 43
Feeding Tube Assessed [12] 368 356
Progressed [13] 76 122
Completed [14] 406 399
Not Completed 18 26
Reason Not Completed
Protocol Violation             17             23
HIV positive             1             3
[1]
All eligible participants
[2]
Eligible and started study treatment
[3]
Eligible, started study treatment, and had adverse events (AE) assessment 1 month post-treatment
[4]
Eligible, started study treatment, and had adverse events assessment 3 months post-treatment
[5]
Eligible, started study treatment, and had adverse events assessment 6 months post-treatment
[6]
Eligible, started study treatment, and had adverse events assessment 1 year post-treatment
[7]
Eligible, started study treatment, and had adverse events assessment 2 years post-treatment
[8]
Eligible, started study treatment, and had adverse events assessment 5 years post-treatment
[9]
Eligible, started study treatment, and had dental health assessment 1 year post-treatment
[10]
Eligible, started study treatment, and had dental health assessment 2 years post-treatment
[11]
Eligible, started study treatment, and had dental health assessment 5 years post-treatment
[12]
Eligible, started study treatment, and had feeding tube assessment 1 year post-treatment
[13]
Eligible and experienced local, regional, or distant progression or death
[14]
Subjects contributing any data to analysis are considered to have completed the study
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab Total
Hide Arm/Group Description

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

 Total of all reporting groups
Overall Number of Baseline Participants 406 399 805
Hide Baseline Analysis Population Description
Eligible participants
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 406 participants 399 participants 805 participants
58
(52 to 63)
58
(52 to 63)
58
(52 to 63)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 406 participants 399 participants 805 participants
<= 65
344
  84.7%
345
  86.5%
689
  85.6%
> 65
62
  15.3%
54
  13.5%
116
  14.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 406 participants 399 participants 805 participants
Female
33
   8.1%
44
  11.0%
77
   9.6%
Male
373
  91.9%
355
  89.0%
728
  90.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 406 participants 399 participants 805 participants
Hispanic or Latino
11
   2.7%
15
   3.8%
26
   3.2%
Not Hispanic or Latino
383
  94.3%
369
  92.5%
752
  93.4%
Unknown or Not Reported
12
   3.0%
15
   3.8%
27
   3.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 406 participants 399 participants 805 participants
White
380
  93.6%
367
  92.0%
747
  92.8%
Black
17
   4.2%
19
   4.8%
36
   4.5%
Other
2
   0.5%
8
   2.0%
10
   1.2%
Unknown
7
   1.7%
5
   1.3%
12
   1.5%
Zubrod performance status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 406 participants 399 participants 805 participants
0
295
  72.7%
300
  75.2%
595
  73.9%
1
111
  27.3%
99
  24.8%
210
  26.1%
[1]
Measure Description: Measure Description: 0 - Asymptomatic; 1 - Symptomatic but completely ambulatory; 2 - Symptomatic, <50% in bed during the day; 3 - Symptomatic, >50% in bed, but not bedbound; 4 - Bedbound; 5 - Death
Smoking history   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 406 participants 399 participants 805 participants
0 pack-years
194
  47.8%
181
  45.4%
375
  46.6%
>0 to <= 10 pack-years
59
  14.5%
68
  17.0%
127
  15.8%
>10 pack-years
153
  37.7%
150
  37.6%
303
  37.6%
[1]
Measure Description: Smoking history as measured in pack-years. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.
Smoking history   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Pack-years
Number Analyzed 406 participants 399 participants 805 participants
2
(0 to 22)
3
(0 to 24)
2
(0 to 23)
[1]
Measure Description: Measure Description: Smoking history as measured in pack-years. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.
Primary site   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 406 participants 399 participants 805 participants
Tonsillar fossa, tonsil
202
  49.8%
199
  49.9%
401
  49.8%
Base of tongue
174
  42.9%
179
  44.9%
353
  43.9%
Oropharynx, not otherwise specified
16
   3.9%
15
   3.8%
31
   3.9%
Pharyngeal oropharynx
8
   2.0%
5
   1.3%
13
   1.6%
Soft palate
4
   1.0%
0
   0.0%
4
   0.5%
Vallecula
2
   0.5%
1
   0.3%
3
   0.4%
[1]
Measure Description: Primary location of tumor
Tumor stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 406 participants 399 participants 805 participants
T1
89
  21.9%
86
  21.6%
175
  21.7%
T2
162
  39.9%
163
  40.9%
325
  40.4%
T3
108
  26.6%
100
  25.1%
208
  25.8%
T4
47
  11.6%
50
  12.5%
97
  12.0%
[1]
Measure Description: Tumor stage per the American Joint Committee on Cancer (AJCC) 7th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues.
Node category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 406 participants 399 participants 805 participants
N0
20
   4.9%
14
   3.5%
34
   4.2%
N1
20
   4.9%
25
   6.3%
45
   5.6%
N2a
59
  14.5%
56
  14.0%
115
  14.3%
N2b
209
  51.5%
208
  52.1%
417
  51.8%
N2c
82
  20.2%
83
  20.8%
165
  20.5%
N3
16
   3.9%
13
   3.3%
29
   3.6%
[1]
Measure Description: Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 7th ed. refers to the number and/or extent of spread of lymph nodes that contain cancer. The higher the number after the N, the greater the involvement of regional lymph nodes.
Overall stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 406 participants 399 participants 805 participants
III
29
   7.1%
31
   7.8%
60
   7.5%
IV
377
  92.9%
368
  92.2%
745
  92.5%
[1]
Measure Description: Overall cancer stage per American Joint Committee on Cancer (AJCC) 7th ed. combines tumor (T), regional lymph node (N), and distant metastasis (M) staging to determine an overall stage of 0, I, II, III, or IV, ranging from least to most advanced, respectively. Stage III: T3/N0/M0 or T1-3/N1/M0; Stage IV: T4/any N/M0 or any T/N2-3/M0.
Risk group per study RTOG-0129   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 406 participants 399 participants 805 participants
Low risk
289
  71.2%
284
  71.2%
573
  71.2%
Intermediate risk
117
  28.8%
115
  28.8%
232
  28.8%
[1]
Measure Description: Risk group as defined by recursive partitioning analysis of study RTOG-0129 (NCT00047008). Low-risk consists of patients with p16-positive tumors and 10 or fewer pack-years or p16-positive, >10 pack-years, and N0-2a disease. Intermediate-risk consists of p16-positive, >10 pack-years, and N2b-3 disease or p16-negative, 10 or fewer pack-years, and T2-3 disease. High-risk consists of p16-negative, 10 or fewer pack-years, and T4 disease or p16-negative and >10 pack-years.
1.Primary Outcome
Title Overall Survival
Hide Description An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time Frame From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 406 399
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84.6
(80.6 to 88.6)
77.9
(73.4 to 82.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMRT + Cisplatin, IMRT + Cetuximab
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The non-inferiority margin was set at 1.45 (hazard ratio scale; IMRT + Cetuximab / IMRT + Cisplatin). If the upper limit of the 95% confidence interval was <1.45, non-inferiority would be concluded. Design was based on a group sequential design with 3 interim analyses, one-sided 0.05, and 80% power.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.45
Confidence Interval (1-Sided) 95%
1.94
Estimation Comments Reference level = IMRT + Cisplatin
2.Secondary Outcome
Title Progression-free Survival
Hide Description An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time Frame From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 406 399
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78.4
(73.8 to 83.0)
67.3
(62.4 to 72.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMRT + Cisplatin, IMRT + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Log Rank
Comments Two-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.72
Confidence Interval (2-Sided) 95%
1.29 to 2.29
Estimation Comments Reference level = IMRT + Cisplatin
3.Secondary Outcome
Title Time to Local-regional Failure
Hide Description Failure for local-regional failure endpoint was defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown > 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and death due to other causes were considered competing risks. Local-regional failure time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of local-regional failure times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time Frame From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 406 399
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.9
(6.9 to 13.6)
17.3
(13.7 to 21.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMRT + Cisplatin, IMRT + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Log Rank
Comments Two-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.05
Confidence Interval (2-Sided) 95%
1.35 to 3.10
Estimation Comments Reference level = IMRT + Cisplatin
4.Secondary Outcome
Title Time to Distant Metastasis
Hide Description Failure for distant metastasis endpoint was defined as distant progression; local-regional failure and death due to any cause were considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of distant metastasis times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time Frame From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 406 399
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.6
(5.8 to 11.9)
11.7
(8.6 to 15.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMRT + Cisplatin, IMRT + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments Two-sided significance level = 0.05
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.49
Confidence Interval (2-Sided) 95%
0.94 to 2.36
Estimation Comments Reference level = IMRT + Cisplatin
5.Secondary Outcome
Title Time to Secondary Primary Cancer
Hide Description Failure for second primary endpoint was defined as reporting of a new primary cancer; death due to any cause was considered a competing risk. Second primary time is defined as time from randomization to the date of second primary or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of second primary cancer times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Time Frame From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 406 399
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.9
(6.9 to 13.4)
10.3
(7.1 to 14.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMRT + Cisplatin, IMRT + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments Two-sided significance level = 0.05
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.61 to 1.58
Estimation Comments Reference level = IMRT + Cisplatin
6.Secondary Outcome
Title Distribution of First Progression Events
Hide Description The first event type for progression-free survival is counted for each participant. Possible first progression events are local, regional, or distant progression, any combination of these, or death. The frequency table of these events is also referred to as "Pattern of failure."
Time Frame From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants with progression-free survival failure
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 76 122
Measure Type: Count of Participants
Unit of Measure: Participants
Local
13
  17.1%
25
  20.5%
Regional
6
   7.9%
14
  11.5%
Local and regional
4
   5.3%
8
   6.6%
Local and distant
0
   0.0%
1
   0.8%
Regional and distant
0
   0.0%
5
   4.1%
Local, regional, and distant
0
   0.0%
2
   1.6%
Distant
31
  40.8%
43
  35.2%
Death, due to this disease
2
   2.6%
0
   0.0%
Death, due to second primary
1
   1.3%
3
   2.5%
Death, due to other reason
10
  13.2%
11
   9.0%
Death, due to unknown reason
9
  11.8%
10
   8.2%
7.Secondary Outcome
Title Percentage of Participants Experiencing Early Death
Hide Description Early death is defined as death due to adverse event or within 30 days of treatment completion.
Time Frame From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 398 394
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.5
(0.6 to 3.3)
1.5
(0.6 to 3.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMRT + Cisplatin, IMRT + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments Two-sided significance level = 0.05
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: During Treatment
Hide Description Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
Time Frame From start of treatment to end of treatment, approximately 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 398 394
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.6
(71.1 to 79.8)
73.6
(69.0 to 77.9)
9.Secondary Outcome
Title Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 1 Month After End of Study Treatment
Hide Description Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
Time Frame From start of treatment to approximately 2.5 months (1 month after the end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and had adverse events assessment at 1 month after treatment end
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 369 363
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
32.5
(27.8 to 37.6)
31.1
(26.4 to 36.2)
10.Secondary Outcome
Title Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 3 Months After the End of Study Treatment
Hide Description Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
Time Frame From start of treatment to approximately 4.5 months (3 months after the end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and had adverse events assessment at 3 months after treatment end
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 359 367
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
17.5
(13.8 to 21.9)
14.7
(11.3 to 18.8)
11.Secondary Outcome
Title Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 6 Months After the End of Study Treatment
Hide Description Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
Time Frame From start of treatment to approximately 7.5 months (6 months after the end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and had adverse events assessment at 6 months year after treatment end
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 361 352
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.3
(10.0 to 17.2)
9.4
(6.5 to 12.9)
12.Secondary Outcome
Title Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 1 Year After the End of Study Treatment
Hide Description Late adverse events (AE) are defined as > 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
Time Frame From start of treatment to approximately 13.5 months (one year after the end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and had adverse events assessment at 1 year after treatment end
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 360 351
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.0
(7.1 to 13.6)
8.5
(5.8 to 12.0)
13.Secondary Outcome
Title Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 2 Years After the End of Study Treatment
Hide Description Late adverse events (AE) are defined as > 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
Time Frame From 180 days after end of treatment to two years after end of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
.Eligible patients who started study treatment and had adverse events assessment at 2 years after treatment end
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 311 303
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.7
(5.0 to 11.3)
4.0
(2.1 to 6.8)
14.Secondary Outcome
Title Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 5 Years After the End of Study Treatment
Hide Description Late adverse events (AE) are defined as > 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE
Time Frame From start of treatment to approximately 61.5 months (five years after the end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and had adverse events assessment at 5 years after treatment end
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 92 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.3
(1.2 to 10.8)
7.0
(2.6 to 14.6)
15.Secondary Outcome
Title Percentage of Participants With a Feeding Tube at 1 Year
Hide Description [Not Specified]
Time Frame From randomization to 1 year.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and had feeding tube assessment at 1 year
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 368 356
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.2
(6.5 to 12.7)
8.4
(5.8 to 11.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMRT + Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments Two-sided significance level = 0.05
Method Fisher Exact
Comments [Not Specified]
16.Secondary Outcome
Title EORTC QLQ-C30 at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.
Hide Description [Not Specified]
Time Frame From randomization to 1 year after end of treatment.
Outcome Measure Data Not Reported
17.Secondary Outcome
Title EORTC QLQ-H&N35 at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.
Hide Description [Not Specified]
Time Frame From randomization to 1 year after end of treatment.
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Head and Neck (PRO-CTCAE H&N) at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.
Hide Description [Not Specified]
Time Frame From randomization to 1 year after end of treatment.
Outcome Measure Data Not Reported
19.Secondary Outcome
Title EuroQol Five Dimension Scale (EQ-5D) at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.
Hide Description [Not Specified]
Time Frame From randomization to 1 year after end of treatment.
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Work Status Questionnaire at Baseline, End of Treatment, 3, 6, and 12 Months.
Hide Description [Not Specified]
Time Frame From randomization to 1 year after end of treatment.
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Percentage of Patients With Normal/Good Dental Health: Pretreatment
Hide Description

This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease";

1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated." Ten year data is not yet available.
Time Frame Before treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 398 394
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
71.1
(66.4 to 75.5)
74.6
(70.0 to 78.8)
22.Secondary Outcome
Title Percentage of Patients With Normal/Good Dental Health: 1 Year After End of Treatment
Hide Description

This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease";

1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated."
Time Frame 1 year after end of treatment (approximately 13.5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and had dental status assessment at 1 year after treatment end
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 267 267
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87.3
(82.7 to 91.0)
83.5
(78.5 to 87.8)
23.Secondary Outcome
Title Percentage of Patients With Normal/Good Dental Health: 2 Years After End of Treatment
Hide Description This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated."
Time Frame 2 years after end of treatment (approximately 25.5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and had dental status assessment at 2 years after treatment end
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 208 201
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.5
(81.1 to 90.9)
82.1
(76.1 to 87.1)
24.Secondary Outcome
Title Percentage of Patients With Normal/Good Dental Health: 5 Years After End of Treatment
Hide Description This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated."
Time Frame 5 years after end of treatment (approximately 61.5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and had dental status assessment at 5 years after treatment end
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description:

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Overall Number of Participants Analyzed 44 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.6
(75.4 to 96.2)
86.0
(72.1 to 94.7)
25.Secondary Outcome
Title Percentage of Patients With Normal/Good Dental Health: 10 Years After End of Treatment
Hide Description

his study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease";

1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated."
Time Frame 10 years after end of treatment (approximately 121.5 months)
Outcome Measure Data Not Reported
26.Secondary Outcome
Title Hearing Quality of Life Outcomes as Measured by the Hearing Handicap Inventory for Adults (HHIA-S) at Baseline, End of Treatment and at 3, 6, and 12 Months From End of Treatment.
Hide Description [Not Specified]
Time Frame From randomization to 1 year after end of treatment.
Outcome Measure Data Not Reported
27.Secondary Outcome
Title Behavioral Risk Assessment Survey (BRASS) at Baseline.
Hide Description [Not Specified]
Time Frame Prior to randomization.
Outcome Measure Data Not Reported
28.Secondary Outcome
Title Translational Research Analysis
Hide Description [Not Specified]
Time Frame From randomization to date of death or last follow-up.
Outcome Measure Data Not Reported
Time Frame From randomization to last follow-up. Maximum follow-up was 7.4 years.
Adverse Event Reporting Description Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event
 
Arm/Group Title IMRT + Cisplatin IMRT + Cetuximab
Hide Arm/Group Description

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
All-Cause Mortality
IMRT + Cisplatin IMRT + Cetuximab
Affected / at Risk (%) Affected / at Risk (%)
Total   64/406 (15.76%)   86/399 (21.55%) 
Hide Serious Adverse Events
IMRT + Cisplatin IMRT + Cetuximab
Affected / at Risk (%) Affected / at Risk (%)
Total   177/398 (44.47%)   115/394 (29.19%) 
Blood and lymphatic system disorders     
Anemia * 1  1/398 (0.25%)  1/394 (0.25%) 
Febrile neutropenia * 1  14/398 (3.52%)  1/394 (0.25%) 
Leukocytosis * 1  1/398 (0.25%)  0/394 (0.00%) 
Spleen disorder * 1  1/398 (0.25%)  0/394 (0.00%) 
Cardiac disorders     
Acute coronary syndrome * 1  0/398 (0.00%)  1/394 (0.25%) 
Aortic valve disease * 1  1/398 (0.25%)  0/394 (0.00%) 
Atrial fibrillation * 1  2/398 (0.50%)  2/394 (0.51%) 
Cardiac arrest * 1  1/398 (0.25%)  2/394 (0.51%) 
Cardiac disorders - Other * 1  1/398 (0.25%)  0/394 (0.00%) 
Chest pain - cardiac * 1  1/398 (0.25%)  0/394 (0.00%) 
Left ventricular systolic dysfunction * 1  1/398 (0.25%)  0/394 (0.00%) 
Myocardial infarction * 1  0/398 (0.00%)  2/394 (0.51%) 
Sinus bradycardia * 1  0/398 (0.00%)  2/394 (0.51%) 
Sinus tachycardia * 1  2/398 (0.50%)  3/394 (0.76%) 
Supraventricular tachycardia * 1  0/398 (0.00%)  1/394 (0.25%) 
Ventricular tachycardia * 1  0/398 (0.00%)  1/394 (0.25%) 
Ear and labyrinth disorders     
Hearing impaired † 1  3/398 (0.75%)  1/394 (0.25%) 
Tinnitus † 1  1/398 (0.25%)  0/394 (0.00%) 
Endocrine disorders     
Adrenal insufficiency * 1  1/398 (0.25%)  0/394 (0.00%) 
Hyperthyroidism * 1  1/398 (0.25%)  0/394 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  2/398 (0.50%)  1/394 (0.25%) 
Colonic fistula * 1  1/398 (0.25%)  0/394 (0.00%) 
Colonic perforation * 1  1/398 (0.25%)  0/394 (0.00%) 
Constipation † 1  11/398 (2.76%)  1/394 (0.25%) 
Diarrhea † 1  4/398 (1.01%)  1/394 (0.25%) 
Dry mouth † 1  2/398 (0.50%)  5/394 (1.27%) 
Dyspepsia † 1  1/398 (0.25%)  0/394 (0.00%) 
Dysphagia † 1  23/398 (5.78%)  17/394 (4.31%) 
Esophageal pain * 1  2/398 (0.50%)  1/394 (0.25%) 
Esophageal stenosis * 1  3/398 (0.75%)  1/394 (0.25%) 
Esophagitis * 1  1/398 (0.25%)  4/394 (1.02%) 
Gastric hemorrhage * 1  0/398 (0.00%)  1/394 (0.25%) 
Gastroesophageal reflux disease * 1  1/398 (0.25%)  0/394 (0.00%) 
Gastrointestinal disorders - Other * 1  2/398 (0.50%)  0/394 (0.00%) 
Ileus * 1  1/398 (0.25%)  0/394 (0.00%) 
Mucositis oral † 1  18/398 (4.52%)  22/394 (5.58%) 
Nausea † 1  38/398 (9.55%)  18/394 (4.57%) 
Obstruction gastric * 1  0/398 (0.00%)  1/394 (0.25%) 
Oral cavity fistula * 1  1/398 (0.25%)  0/394 (0.00%) 
Oral hemorrhage * 1  1/398 (0.25%)  1/394 (0.25%) 
Oral pain * 1  7/398 (1.76%)  2/394 (0.51%) 
Pancreatitis * 1  2/398 (0.50%)  1/394 (0.25%) 
Rectal pain * 1  0/398 (0.00%)  1/394 (0.25%) 
Retroperitoneal hemorrhage * 1  1/398 (0.25%)  0/394 (0.00%) 
Stomach pain * 1  1/398 (0.25%)  0/394 (0.00%) 
Vomiting † 1  34/398 (8.54%)  14/394 (3.55%) 
General disorders     
Death NOS * 1  0/398 (0.00%)  1/394 (0.25%) 
Fatigue † 1  6/398 (1.51%)  3/394 (0.76%) 
Fever * 1  8/398 (2.01%)  8/394 (2.03%) 
Flu like symptoms * 1  1/398 (0.25%)  0/394 (0.00%) 
Infusion related reaction * 1  0/398 (0.00%)  8/394 (2.03%) 
Localized edema * 1  1/398 (0.25%)  0/394 (0.00%) 
Pain † 1  12/398 (3.02%)  9/394 (2.28%) 
Sudden death NOS * 1  4/398 (1.01%)  2/394 (0.51%) 
Hepatobiliary disorders     
Portal vein thrombosis * 1  1/398 (0.25%)  0/394 (0.00%) 
Immune system disorders     
Allergic reaction * 1  0/398 (0.00%)  1/394 (0.25%) 
Anaphylaxis * 1  0/398 (0.00%)  1/394 (0.25%) 
Infections and infestations     
Abdominal infection * 1  1/398 (0.25%)  0/394 (0.00%) 
Anorectal infection * 1  1/398 (0.25%)  1/394 (0.25%) 
Bronchial infection * 1  1/398 (0.25%)  0/394 (0.00%) 
Catheter related infection * 1  2/398 (0.50%)  1/394 (0.25%) 
Enterocolitis infectious * 1  1/398 (0.25%)  2/394 (0.51%) 
Infections and infestations - Other * 1  2/398 (0.50%)  2/394 (0.51%) 
Joint infection * 1  0/398 (0.00%)  1/394 (0.25%) 
Lung infection * 1  7/398 (1.76%)  5/394 (1.27%) 
Mucosal infection * 1  3/398 (0.75%)  1/394 (0.25%) 
Rash pustular * 1  0/398 (0.00%)  1/394 (0.25%) 
Sepsis * 1  3/398 (0.75%)  1/394 (0.25%) 
Sinusitis * 1  0/398 (0.00%)  1/394 (0.25%) 
Skin infection * 1  2/398 (0.50%)  2/394 (0.51%) 
Soft tissue infection * 1  2/398 (0.50%)  1/394 (0.25%) 
Upper respiratory infection * 1  2/398 (0.50%)  0/394 (0.00%) 
Urinary tract infection * 1  0/398 (0.00%)  1/394 (0.25%) 
Wound infection * 1  1/398 (0.25%)  0/394 (0.00%) 
Injury, poisoning and procedural complications     
Arterial injury * 1  0/398 (0.00%)  1/394 (0.25%) 
Dermatitis radiation † 1  0/398 (0.00%)  5/394 (1.27%) 
Fall * 1  1/398 (0.25%)  0/394 (0.00%) 
Fracture * 1  1/398 (0.25%)  1/394 (0.25%) 
Injury, poisoning and procedural complications - Other * 1  2/398 (0.50%)  2/394 (0.51%) 
Vascular access complication * 1  0/398 (0.00%)  1/394 (0.25%) 
Wound dehiscence * 1  1/398 (0.25%)  0/394 (0.00%) 
Investigations     
Alanine aminotransferase increased * 1  1/398 (0.25%)  1/394 (0.25%) 
Aspartate aminotransferase increased * 1  1/398 (0.25%)  0/394 (0.00%) 
CPK increased * 1  1/398 (0.25%)  0/394 (0.00%) 
Creatinine increased * 1  5/398 (1.26%)  0/394 (0.00%) 
INR increased * 1  1/398 (0.25%)  0/394 (0.00%) 
Investigations - Other * 1  0/398 (0.00%)  1/394 (0.25%) 
Lipase increased * 1  1/398 (0.25%)  0/394 (0.00%) 
Lymphocyte count decreased * 1  12/398 (3.02%)  11/394 (2.79%) 
Neutrophil count decreased * 1  13/398 (3.27%)  0/394 (0.00%) 
Weight gain * 1  1/398 (0.25%)  0/394 (0.00%) 
Weight loss * 1  8/398 (2.01%)  5/394 (1.27%) 
White blood cell decreased * 1  6/398 (1.51%)  0/394 (0.00%) 
Metabolism and nutrition disorders     
Anorexia † 1  9/398 (2.26%)  4/394 (1.02%) 
Dehydration * 1  43/398 (10.80%)  20/394 (5.08%) 
Hyperglycemia * 1  2/398 (0.50%)  2/394 (0.51%) 
Hyperkalemia * 1  1/398 (0.25%)  0/394 (0.00%) 
Hypernatremia * 1  0/398 (0.00%)  1/394 (0.25%) 
Hypocalcemia * 1  1/398 (0.25%)  2/394 (0.51%) 
Hypoglycemia * 1  0/398 (0.00%)  1/394 (0.25%) 
Hypokalemia * 1  2/398 (0.50%)  5/394 (1.27%) 
Hypomagnesemia * 1  1/398 (0.25%)  2/394 (0.51%) 
Hyponatremia * 1  8/398 (2.01%)  0/394 (0.00%) 
Hypophosphatemia * 1  1/398 (0.25%)  0/394 (0.00%) 
Musculoskeletal and connective tissue disorders     
Generalized muscle weakness * 1  3/398 (0.75%)  1/394 (0.25%) 
Joint effusion * 1  0/398 (0.00%)  1/394 (0.25%) 
Neck pain * 1  3/398 (0.75%)  0/394 (0.00%) 
Osteonecrosis of jaw * 1  4/398 (1.01%)  4/394 (1.02%) 
Trismus † 1  1/398 (0.25%)  1/394 (0.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Myelodysplastic syndrome * 1  1/398 (0.25%)  0/394 (0.00%) 
Nervous system disorders     
Dysgeusia † 1  0/398 (0.00%)  2/394 (0.51%) 
Encephalopathy * 1  1/398 (0.25%)  1/394 (0.25%) 
Headache * 1  1/398 (0.25%)  0/394 (0.00%) 
Intracranial hemorrhage * 1  1/398 (0.25%)  0/394 (0.00%) 
Movements involuntary * 1  0/398 (0.00%)  1/394 (0.25%) 
Myelitis * 1  1/398 (0.25%)  0/394 (0.00%) 
Paresthesia * 1  1/398 (0.25%)  0/394 (0.00%) 
Presyncope * 1  1/398 (0.25%)  1/394 (0.25%) 
Somnolence * 1  1/398 (0.25%)  0/394 (0.00%) 
Syncope * 1  6/398 (1.51%)  1/394 (0.25%) 
Transient ischemic attacks * 1  1/398 (0.25%)  0/394 (0.00%) 
Psychiatric disorders     
Agitation * 1  1/398 (0.25%)  0/394 (0.00%) 
Anxiety * 1  2/398 (0.50%)  0/394 (0.00%) 
Confusion * 1  1/398 (0.25%)  1/394 (0.25%) 
Delirium * 1  0/398 (0.00%)  1/394 (0.25%) 
Depression * 1  1/398 (0.25%)  0/394 (0.00%) 
Hallucinations * 1  1/398 (0.25%)  0/394 (0.00%) 
Restlessness * 1  1/398 (0.25%)  0/394 (0.00%) 
Suicide attempt * 1  1/398 (0.25%)  0/394 (0.00%) 
Renal and urinary disorders     
Acute kidney injury * 1  21/398 (5.28%)  1/394 (0.25%) 
Urinary retention * 1  2/398 (0.50%)  0/394 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome * 1  1/398 (0.25%)  0/394 (0.00%) 
Aspiration * 1  2/398 (0.50%)  2/394 (0.51%) 
Cough † 1  0/398 (0.00%)  1/394 (0.25%) 
Dyspnea * 1  4/398 (1.01%)  1/394 (0.25%) 
Hypoxia * 1  3/398 (0.75%)  0/394 (0.00%) 
Laryngeal edema * 1  1/398 (0.25%)  0/394 (0.00%) 
Laryngeal hemorrhage * 1  1/398 (0.25%)  0/394 (0.00%) 
Pharyngeal hemorrhage * 1  1/398 (0.25%)  0/394 (0.00%) 
Pharyngeal mucositis † 1  2/398 (0.50%)  1/394 (0.25%) 
Pharyngeal necrosis * 1  2/398 (0.50%)  0/394 (0.00%) 
Pharyngolaryngeal pain * 1  2/398 (0.50%)  1/394 (0.25%) 
Pleural effusion * 1  1/398 (0.25%)  0/394 (0.00%) 
Pneumonitis * 1  1/398 (0.25%)  0/394 (0.00%) 
Respiratory failure * 1  1/398 (0.25%)  2/394 (0.51%) 
Respiratory, thoracic and mediastinal disorders - Other * 1  2/398 (0.50%)  0/394 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash acneiform † 1  0/398 (0.00%)  5/394 (1.27%) 
Rash maculo-papular † 1  0/398 (0.00%)  2/394 (0.51%) 
Skin hyperpigmentation * 1  0/398 (0.00%)  1/394 (0.25%) 
Surgical and medical procedures     
Surgical and medical procedures - Other * 1  1/398 (0.25%)  0/394 (0.00%) 
Vascular disorders     
Hypertension * 1  1/398 (0.25%)  1/394 (0.25%) 
Hypotension * 1  3/398 (0.75%)  0/394 (0.00%) 
Lymphedema * 1  1/398 (0.25%)  0/394 (0.00%) 
Thromboembolic event * 1  8/398 (2.01%)  2/394 (0.51%) 
Vascular disorders - Other * 1  3/398 (0.75%)  1/394 (0.25%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IMRT + Cisplatin IMRT + Cetuximab
Affected / at Risk (%) Affected / at Risk (%)
Total   398/398 (100.00%)   393/394 (99.75%) 
Blood and lymphatic system disorders     
Anemia * 1  185/398 (46.48%)  118/394 (29.95%) 
Ear and labyrinth disorders     
Ear pain * 1  30/398 (7.54%)  36/394 (9.14%) 
Hearing impaired † 1  192/398 (48.24%)  104/394 (26.40%) 
Tinnitus † 1  204/398 (51.26%)  100/394 (25.38%) 
Endocrine disorders     
Hyperthyroidism * 1  20/398 (5.03%)  10/394 (2.54%) 
Hypothyroidism * 1  74/398 (18.59%)  69/394 (17.51%) 
Gastrointestinal disorders     
Abdominal pain * 1  21/398 (5.28%)  15/394 (3.81%) 
Constipation † 1  240/398 (60.30%)  214/394 (54.31%) 
Diarrhea † 1  94/398 (23.62%)  87/394 (22.08%) 
Dry mouth † 1  376/398 (94.47%)  372/394 (94.42%) 
Dyspepsia † 1  123/398 (30.90%)  88/394 (22.34%) 
Dysphagia † 1  371/398 (93.22%)  351/394 (89.09%) 
Gastroesophageal reflux disease * 1  13/398 (3.27%)  23/394 (5.84%) 
Gastrointestinal disorders - Other * 1  54/398 (13.57%)  61/394 (15.48%) 
Mucositis oral † 1  363/398 (91.21%)  370/394 (93.91%) 
Nausea † 1  301/398 (75.63%)  238/394 (60.41%) 
Oral pain * 1  34/398 (8.54%)  60/394 (15.23%) 
Salivary duct inflammation * 1  32/398 (8.04%)  34/394 (8.63%) 
Vomiting † 1  206/398 (51.76%)  150/394 (38.07%) 
General disorders     
Chills * 1  19/398 (4.77%)  27/394 (6.85%) 
Fatigue † 1  357/398 (89.70%)  345/394 (87.56%) 
Fever * 1  22/398 (5.53%)  46/394 (11.68%) 
General disorders and administration site conditions - Other * 1  11/398 (2.76%)  20/394 (5.08%) 
Neck edema * 1  42/398 (10.55%)  33/394 (8.38%) 
Pain † 1  329/398 (82.66%)  324/394 (82.23%) 
Infections and infestations     
Infections and infestations - Other * 1  29/398 (7.29%)  32/394 (8.12%) 
Mucosal infection * 1  53/398 (13.32%)  43/394 (10.91%) 
Injury, poisoning and procedural complications     
Dermatitis radiation † 1  316/398 (79.40%)  305/394 (77.41%) 
Investigations     
Alanine aminotransferase increased * 1  52/398 (13.07%)  67/394 (17.01%) 
Alkaline phosphatase increased * 1  18/398 (4.52%)  20/394 (5.08%) 
Aspartate aminotransferase increased * 1  35/398 (8.79%)  53/394 (13.45%) 
Creatinine increased * 1  97/398 (24.37%)  23/394 (5.84%) 
Investigations - Other * 1  21/398 (5.28%)  14/394 (3.55%) 
Lymphocyte count decreased * 1  98/398 (24.62%)  101/394 (25.63%) 
Neutrophil count decreased * 1  106/398 (26.63%)  17/394 (4.31%) 
Platelet count decreased * 1  100/398 (25.13%)  23/394 (5.84%) 
Weight loss * 1  203/398 (51.01%)  211/394 (53.55%) 
White blood cell decreased * 1  157/398 (39.45%)  53/394 (13.45%) 
Metabolism and nutrition disorders     
Anorexia † 1  263/398 (66.08%)  253/394 (64.21%) 
Dehydration * 1  97/398 (24.37%)  68/394 (17.26%) 
Hyperglycemia * 1  90/398 (22.61%)  97/394 (24.62%) 
Hyperkalemia * 1  25/398 (6.28%)  17/394 (4.31%) 
Hypermagnesemia * 1  20/398 (5.03%)  9/394 (2.28%) 
Hypoalbuminemia * 1  94/398 (23.62%)  101/394 (25.63%) 
Hypocalcemia * 1  73/398 (18.34%)  45/394 (11.42%) 
Hypokalemia * 1  64/398 (16.08%)  48/394 (12.18%) 
Hypomagnesemia * 1  64/398 (16.08%)  66/394 (16.75%) 
Hyponatremia * 1  132/398 (33.17%)  81/394 (20.56%) 
Metabolism and nutrition disorders - Other * 1  21/398 (5.28%)  14/394 (3.55%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  20/398 (5.03%)  16/394 (4.06%) 
Fibrosis deep connective tissue * 1  32/398 (8.04%)  29/394 (7.36%) 
Musculoskeletal and connective tissue disorder - Other * 1  38/398 (9.55%)  31/394 (7.87%) 
Neck pain * 1  46/398 (11.56%)  44/394 (11.17%) 
Neck soft tissue necrosis † 1  21/398 (5.28%)  20/394 (5.08%) 
Superficial soft tissue fibrosis * 1  29/398 (7.29%)  48/394 (12.18%) 
Trismus † 1  98/398 (24.62%)  103/394 (26.14%) 
Nervous system disorders     
Dizziness * 1  51/398 (12.81%)  33/394 (8.38%) 
Dysgeusia † 1  349/398 (87.69%)  334/394 (84.77%) 
Headache * 1  47/398 (11.81%)  65/394 (16.50%) 
Peripheral sensory neuropathy † 1  104/398 (26.13%)  62/394 (15.74%) 
Psychiatric disorders     
Anxiety * 1  45/398 (11.31%)  60/394 (15.23%) 
Depression * 1  49/398 (12.31%)  44/394 (11.17%) 
Insomnia † 1  135/398 (33.92%)  118/394 (29.95%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  147/398 (36.93%)  127/394 (32.23%) 
Dyspnea * 1  33/398 (8.29%)  30/394 (7.61%) 
Hiccups * 1  35/398 (8.79%)  10/394 (2.54%) 
Hoarseness * 1  83/398 (20.85%)  81/394 (20.56%) 
Laryngeal edema * 1  13/398 (3.27%)  23/394 (5.84%) 
Pharyngeal mucositis † 1  137/398 (34.42%)  116/394 (29.44%) 
Respiratory, thoracic and mediastinal disorders - Other * 1  13/398 (3.27%)  25/394 (6.35%) 
Sore throat * 1  71/398 (17.84%)  65/394 (16.50%) 
Voice alteration * 1  30/398 (7.54%)  34/394 (8.63%) 
Skin and subcutaneous tissue disorders     
Alopecia † 1  111/398 (27.89%)  89/394 (22.59%) 
Dry skin † 1  106/398 (26.63%)  140/394 (35.53%) 
Pruritus † 1  42/398 (10.55%)  105/394 (26.65%) 
Rash acneiform † 1  21/398 (5.28%)  300/394 (76.14%) 
Rash maculo-papular † 1  28/398 (7.04%)  96/394 (24.37%) 
Skin and subcutaneous tissue disorders - Other * 1  30/398 (7.54%)  48/394 (12.18%) 
Skin hyperpigmentation * 1  41/398 (10.30%)  49/394 (12.44%) 
Telangiectasia * 1  24/398 (6.03%)  18/394 (4.57%) 
Vascular disorders     
Hypertension * 1  43/398 (10.80%)  39/394 (9.90%) 
Hypotension * 1  24/398 (6.03%)  17/394 (4.31%) 
Lymphedema * 1  32/398 (8.04%)  37/394 (9.39%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
†
Indicates events were collected by systematic assessment
At the third interim analysis the NRG Oncology Data Monitoring Committee recommended the public release of study results.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld
Organization: NRG Oncology
Phone: 215-574-3208
EMail: seiferheldw@nrgoncology.org
Publications of Results:
Gillison ML, Trotti AM, Harris J, Eisbruch A, Harari PM, Adelstein DJ, Jordan RCK, Zhao W, Sturgis EM, Burtness B, Ridge JA, Ringash J, Galvin J, Yao M, Koyfman SA, Blakaj DM, Razaq MA, Colevas AD, Beitler JJ, Jones CU, Dunlap NE, Seaward SA, Spencer S, Galloway TJ, Phan J, Dignam JJ, Le QT. Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial. Lancet. 2019 Jan 5;393(10166):40-50. doi: 10.1016/S0140-6736(18)32779-X. Epub 2018 Nov 15. Erratum In: Lancet. 2020 Mar 7;395(10226):784.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01302834    
Other Study ID Numbers: RTOG-1016
CDR0000695731
NCI-2011-02638 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: February 22, 2011
First Posted: February 24, 2011
Results First Submitted: November 27, 2019
Results First Posted: January 9, 2020
Last Update Posted: October 3, 2023