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Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

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ClinicalTrials.gov Identifier: NCT00632853
Recruitment Status : Active, not recruiting
First Posted : March 11, 2008
Results First Posted : June 12, 2023
Last Update Posted : June 12, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Radiation: Standard Radiation Dose Therapy
Drug: cisplatin
Drug: etoposide
Radiation: High Radiation Dose Therapy
Drug: carboplatin
Enrollment 731
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description

Radiotherapy (every day, Monday-Friday, for a total of 3 weeks)> XRT: 45 Gy BID (1.5 Gy/fx) starting on day 1 of Cycle 1 or 2, every day, for 3 weeks> Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):>

  • Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days>
  • Etoposide 100 mg/m2 IV Register/ on days 1, 2, and 3, every 21 days> Standard Radiation Dose Therapy: 45 Gy

Radiotherapy (every day, Monday-Friday, for a total of 7 weeks)> XRT: 70 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks> Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):>

  • Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days>
  • Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
 Radiotherapy (every day, Monday-Friday, for a total of 5 weeks)> XRT: 61.2 Gy Concomitant boost: QD (1.8 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 16> days of treatment; then BID (1.8 Gy/fx) for 9 days of treatment Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks)> Cisplatin 80 mg/m2 IV on day 1, every 21 days> Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
Period Title: Overall Study
Started 313 325 93
Completed 313 325 93
Not Completed 0 0 0
Arm/Group Title Arm A Arm B Arm C Total
Hide Arm/Group Description

Radiotherapy (every day, Monday-Friday, for a total of 7 weeks)> XRT: 45 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks> Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):>

  • Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days>
  • Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days

Radiotherapy (every day, Monday-Friday, for a total of 7 weeks)> XRT: 70 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks> Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):>

  • Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days>
  • Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days

Radiotherapy (every day, Monday-Friday, for a total of 7 weeks)> XRT: 61.2 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks> Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):>

  • Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days>
  • Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
 Total of all reporting groups
Overall Number of Baseline Participants 313 325 93 731
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 313 participants 325 participants 93 participants 731 participants
63.3
(42 to 81)
62.4
(37 to 80)
61.7
(41 to 77)
62.7
(37 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 313 participants 325 participants 93 participants 731 participants
Female
159
  50.8%
170
  52.3%
46
  49.5%
375
  51.3%
Male
154
  49.2%
155
  47.7%
47
  50.5%
356
  48.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 313 participants 325 participants 93 participants 731 participants
Hispanic or Latino
11
   3.5%
9
   2.8%
5
   5.4%
25
   3.4%
Not Hispanic or Latino
292
  93.3%
302
  92.9%
85
  91.4%
679
  92.9%
Unknown or Not Reported
10
   3.2%
14
   4.3%
3
   3.2%
27
   3.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 313 participants 325 participants 93 participants 731 participants
American Indian or Alaska Native
2
   0.6%
2
   0.6%
1
   1.1%
5
   0.7%
Asian
4
   1.3%
4
   1.2%
1
   1.1%
9
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
27
   8.6%
27
   8.3%
11
  11.8%
65
   8.9%
White
271
  86.6%
281
  86.5%
80
  86.0%
632
  86.5%
More than one race
0
   0.0%
1
   0.3%
0
   0.0%
1
   0.1%
Unknown or Not Reported
9
   2.9%
10
   3.1%
0
   0.0%
19
   2.6%
1.Primary Outcome
Title Overall Survival Time
Hide Description Overall survival time is defined as the time between a patient's registration and death or end of survival follow up.
Time Frame 11.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
All registered patients were included in this analysis.
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description:
Radiotherapy (every day, Monday-Friday, for a total of 3 weeks) XRT: 45 Gy BID (1.5 Gy/fx) starting on day 1 of Cycle 1 or 2, every day, for 3 weeks> Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):> Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days> Etoposide 100 mg/m2 IV Register/ on days 1, 2, and 3, every 21 days Standard Radiation Dose Therapy: 45 Gy
Radiotherapy (every day, Monday-Friday, for a total of 7 weeks) XRT: 70 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks> Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):> Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days> Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
Radiotherapy (every day, Monday-Friday, for a total of 5 weeks)> XRT: 61.2 Gy Concomitant boost: QD (1.8 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 16> days of treatment; then BID (1.8 Gy/fx) for 9 days of treatment Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks)> Cisplatin 80 mg/m2 IV on day 1, every 21 days> Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
Overall Number of Participants Analyzed 313 325 93
Median (95% Confidence Interval)
Unit of Measure: Months
28.7
(26.2 to 35.5)
30.5
(24.4 to 39.6)
32.3
(21.1 to 44.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B, Arm C
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8741
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Complete and Partial Response Rates
Hide Description [Not Specified]
Time Frame 11.25 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Failure-free >> Survival
Hide Description [Not Specified]
Time Frame Up to 5 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title To Compare Rates of Local Relapse, Distant Metastases and Brain Metastases With These > Regimens.
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title To Compare Patients' Quality of Life Between These Treatment Regimens in Terms of Their > Physical Symptoms, Physical Functioning and Psychological State.
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title To Describe the Patterns of Use of Thoracic Intensity Modulated Radiation Therapy (IMRT) in Patients With Limited Stage Small Cell Lung Cancer.
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title To Examine Blood-based Biomarkers of Response and Resistance to Cisplatin (or Carboplatin) and Etoposide.
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
8.Secondary Outcome
Title To Evaluate the Correspondence Between Increases in Plasma ProGRP Concentrations and Disease Progression/Recurrence
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
9.Secondary Outcome
Title To Evaluate the Potential for Plasma ProGRP Concentrations at Baseline, After Each Cycle of > Chemotherapy and at First Evaluation Following Completion of Chemotherapy to Predict PFS and OS.
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
10.Secondary Outcome
Title To Evaluate the Correspondence Between Longitudinal Decreases in Plasma ProGRP Concentrations and Clinical Response.
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
Time Frame Adverse events were collected over 15 months and mortality was collected over 140 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description - Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days - Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days - Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
All-Cause Mortality
Arm A Arm B Arm C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   206/313 (65.81%)      220/325 (67.69%)      73/93 (78.49%)    
Hide Serious Adverse Events
Arm A Arm B Arm C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/313 (1.28%)      11/325 (3.38%)      4/93 (4.30%)    
Blood and lymphatic system disorders       
Febrile neutropenia † 1  0/313 (0.00%)  0 0/325 (0.00%)  0 1/93 (1.08%)  1
Cardiac disorders       
Cardiac disorder † 1  1/313 (0.32%)  1 3/325 (0.92%)  3 1/93 (1.08%)  1
General disorders       
Death NOS † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 1/93 (1.08%)  1
Multi-organ failure † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Sudden death † 1  1/313 (0.32%)  1 3/325 (0.92%)  3 1/93 (1.08%)  1
Immune system disorders       
Hypersensitivity † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Infections and infestations       
Sepsis(gr 3/4 ANC) † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Sepsis(unknown ANC) † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome † 1  0/313 (0.00%)  0 2/325 (0.62%)  2 0/93 (0.00%)  0
1
Term from vocabulary, MedDRA 5
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A Arm B Arm C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   292/313 (93.29%)      296/325 (91.08%)      87/93 (93.55%)    
Blood and lymphatic system disorders       
Blood disorder † 1  7/313 (2.24%)  10 7/325 (2.15%)  12 1/93 (1.08%)  1
Febrile neutropenia † 1  41/313 (13.10%)  51 39/325 (12.00%)  44 11/93 (11.83%)  13
Hemoglobin decreased † 1  246/313 (78.59%)  681 247/325 (76.00%)  660 73/93 (78.49%)  206
Hemolysis † 1  2/313 (0.64%)  2 2/325 (0.62%)  2 0/93 (0.00%)  0
Lymphatic disorder † 1  0/313 (0.00%)  0 0/325 (0.00%)  0 1/93 (1.08%)  1
Thrombotic microangiopathy † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Cardiac disorders       
Atrial fibrillation † 1  6/313 (1.92%)  11 8/325 (2.46%)  8 1/93 (1.08%)  1
Atrial flutter † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 1/93 (1.08%)  1
Atrioventricular block first degree † 1  0/313 (0.00%)  0 0/325 (0.00%)  0 1/93 (1.08%)  1
Cardiac pain † 1  0/313 (0.00%)  0 0/325 (0.00%)  0 1/93 (1.08%)  1
Cardiopulmonary arrest † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Conduction disorder † 1  0/313 (0.00%)  0 0/325 (0.00%)  0 1/93 (1.08%)  1
Left ventricular failure † 1  1/313 (0.32%)  1 1/325 (0.31%)  2 0/93 (0.00%)  0
Myocardial ischemia † 1  2/313 (0.64%)  2 0/325 (0.00%)  0 1/93 (1.08%)  1
Palpitations † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 1/93 (1.08%)  1
Right ventricular dysfunction † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Sinus bradycardia † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Sinus tachycardia † 1  4/313 (1.28%)  5 4/325 (1.23%)  5 4/93 (4.30%)  4
Supraventricular tachycardia † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Ventricular tachycardia † 1  0/313 (0.00%)  0 3/325 (0.92%)  3 0/93 (0.00%)  0
Ear and labyrinth disorders       
Ear disorder † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Ear pain † 1  1/313 (0.32%)  1 1/325 (0.31%)  1 0/93 (0.00%)  0
Hearing impaired † 1  4/313 (1.28%)  8 5/325 (1.54%)  5 2/93 (2.15%)  2
Tinnitus † 1  7/313 (2.24%)  13 8/325 (2.46%)  10 2/93 (2.15%)  2
Endocrine disorders       
Hypothyroidism † 1  1/313 (0.32%)  3 0/325 (0.00%)  0 0/93 (0.00%)  0
Eye disorders       
Dry eye syndrome † 1  0/313 (0.00%)  0 1/325 (0.31%)  2 0/93 (0.00%)  0
Eye disorder † 1  0/313 (0.00%)  0 1/325 (0.31%)  2 0/93 (0.00%)  0
Optic nerve disorder † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Photophobia † 1  0/313 (0.00%)  0 0/325 (0.00%)  0 1/93 (1.08%)  3
Vision blurred † 1  6/313 (1.92%)  8 4/325 (1.23%)  4 1/93 (1.08%)  2
Watering eyes † 1  0/313 (0.00%)  0 0/325 (0.00%)  0 1/93 (1.08%)  4
Gastrointestinal disorders       
Abdominal distension † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Abdominal pain † 1  5/313 (1.60%)  6 10/325 (3.08%)  11 2/93 (2.15%)  4
Colitis † 1  3/313 (0.96%)  3 1/325 (0.31%)  1 0/93 (0.00%)  0
Colonic perforation † 1  1/313 (0.32%)  1 2/325 (0.62%)  2 0/93 (0.00%)  0
Constipation † 1  22/313 (7.03%)  34 29/325 (8.92%)  50 7/93 (7.53%)  11
Diarrhea † 1  20/313 (6.39%)  23 26/325 (8.00%)  35 7/93 (7.53%)  7
Dry mouth † 1  0/313 (0.00%)  0 3/325 (0.92%)  6 1/93 (1.08%)  1
Duodenal hemorrhage † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Duodenal perforation † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Dyspepsia † 1  10/313 (3.19%)  15 11/325 (3.38%)  21 5/93 (5.38%)  7
Dysphagia † 1  161/313 (51.44%)  317 180/325 (55.38%)  361 52/93 (55.91%)  120
Esophageal mucositis (clin exam) † 1  2/313 (0.64%)  4 4/325 (1.23%)  5 0/93 (0.00%)  0
Esophageal mucositis (funct/sympt) † 1  2/313 (0.64%)  2 2/325 (0.62%)  4 1/93 (1.08%)  1
Esophageal pain † 1  177/313 (56.55%)  358 164/325 (50.46%)  323 50/93 (53.76%)  110
Esophageal stenosis † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 1/93 (1.08%)  1
Esophagitis † 1  18/313 (5.75%)  23 46/325 (14.15%)  78 8/93 (8.60%)  8
Flatulence † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Gastric hemorrhage † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Gastritis † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Gastrointestinal disorder † 1  4/313 (1.28%)  6 9/325 (2.77%)  19 1/93 (1.08%)  1
Gastrointestinal pain † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Gingival pain † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Hemorrhoids † 1  0/313 (0.00%)  0 0/325 (0.00%)  0 1/93 (1.08%)  1
Ileus † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Mucositis oral (clin exam) † 1  1/313 (0.32%)  1 2/325 (0.62%)  2 2/93 (2.15%)  2
Mucositis oral (funct/sympt) † 1  0/313 (0.00%)  0 2/325 (0.62%)  3 0/93 (0.00%)  0
Nausea † 1  187/313 (59.74%)  392 188/325 (57.85%)  416 62/93 (66.67%)  142
Oral pain † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Pancreatitis † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Rectal pain † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Small intestinal obstruction † 1  1/313 (0.32%)  1 1/325 (0.31%)  1 0/93 (0.00%)  0
Stomach pain † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Upper gastrointestinal hemorrhage † 1  0/313 (0.00%)  0 2/325 (0.62%)  2 0/93 (0.00%)  0
Vomiting † 1  92/313 (29.39%)  150 105/325 (32.31%)  169 44/93 (47.31%)  72
General disorders       
Chest pain † 1  10/313 (3.19%)  14 16/325 (4.92%)  17 1/93 (1.08%)  2
Chills † 1  1/313 (0.32%)  1 2/325 (0.62%)  3 0/93 (0.00%)  0
Edema limbs † 1  6/313 (1.92%)  7 8/325 (2.46%)  16 2/93 (2.15%)  4
Fatigue † 1  66/313 (21.09%)  141 76/325 (23.38%)  168 26/93 (27.96%)  52
Fever † 1  10/313 (3.19%)  10 2/325 (0.62%)  2 0/93 (0.00%)  0
Flu-like symptoms † 1  0/313 (0.00%)  0 2/325 (0.62%)  2 0/93 (0.00%)  0
Gait abnormal † 1  2/313 (0.64%)  2 1/325 (0.31%)  1 0/93 (0.00%)  0
General symptom † 1  1/313 (0.32%)  1 1/325 (0.31%)  13 0/93 (0.00%)  0
Hypothermia † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Ill-defined disorder † 1  0/313 (0.00%)  0 1/325 (0.31%)  3 0/93 (0.00%)  0
Injection site reaction † 1  1/313 (0.32%)  1 1/325 (0.31%)  1 0/93 (0.00%)  0
Localized edema † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Pain † 1  8/313 (2.56%)  10 17/325 (5.23%)  22 2/93 (2.15%)  2
Hepatobiliary disorders       
Cholecystitis † 1  1/313 (0.32%)  1 1/325 (0.31%)  2 0/93 (0.00%)  0
Immune system disorders       
Cytokine release syndrome † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Hypersensitivity † 1  11/313 (3.51%)  26 14/325 (4.31%)  22 5/93 (5.38%)  5
Immune system disorder † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Infections and infestations       
Abdominal infection † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Bladder infection(gr 3/4 ANC) † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 1/93 (1.08%)  1
Bronchitis(gr 0/1/2 ANC) † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 1/93 (1.08%)  1
Bronchitis(gr 3/4 ANC) † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Bronchitis(unknown ANC) † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Catheter related infection † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 1/93 (1.08%)  1
Catheter related infection(gr 3/4 ANC) † 1  1/313 (0.32%)  1 1/325 (0.31%)  1 0/93 (0.00%)  0
Colitis, infectious † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Encephalitis infection(gr 0/1/2 ANC) † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Endocarditis infective(gr 3/4 ANC) † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Esophageal infection(gr 3/4 ANC) † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Esophageal infection(unknown ANC) † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Eye infection(unknown ANC) † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Gingival infection(gr 0/1/2 ANC) † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Infection(gr 0/1/2 ANC) † 1  11/313 (3.51%)  12 12/325 (3.69%)  14 1/93 (1.08%)  1
Infectious colitis(gr 3/4 ANC) † 1  1/313 (0.32%)  1 1/325 (0.31%)  1 0/93 (0.00%)  0
Kidney infection(gr 0/1/2 ANC) † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Mucosal infection(unknown ANC) † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Opportunistic infection † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Otitis externa(gr 3/4 ANC) † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Paranasal sinus infection(gr 0/1/2 ANC) † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Peritoneal infection(gr 3/4 ANC) † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Pharyngitis † 1  3/313 (0.96%)  5 2/325 (0.62%)  2 0/93 (0.00%)  0
Pneumonia(gr 0/1/2 ANC) † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Pneumonia(gr 3/4 ANC) † 1  4/313 (1.28%)  4 6/325 (1.85%)  6 2/93 (2.15%)  2
Pneumonia(unknown ANC) † 1  1/313 (0.32%)  1 1/325 (0.31%)  2 1/93 (1.08%)  1
Sepsis(gr 0/1/2 ANC) † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Sepsis(gr 3/4 ANC) † 1  1/313 (0.32%)  1 1/325 (0.31%)  1 0/93 (0.00%)  0
Sepsis(unknown ANC) † 1  7/313 (2.24%)  9 2/325 (0.62%)  2 0/93 (0.00%)  0
Sinusitis(gr 0/1/2 ANC) † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Skin infection † 1  3/313 (0.96%)  3 4/325 (1.23%)  6 0/93 (0.00%)  0
Soft tissue infection(gr 3/4 ANC) † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Tooth infection † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Tooth infection(gr 3/4 ANC) † 1  1/313 (0.32%)  1 1/325 (0.31%)  1 0/93 (0.00%)  0
Upper respiratory infection(gr 3/4 ANC) † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Upr aerodigstve trct infctn(unknown ANC) † 1  0/313 (0.00%)  0 1/325 (0.31%)  2 0/93 (0.00%)  0
Urinary tract infection(gr 0/1/2 ANC) † 1  0/313 (0.00%)  0 4/325 (1.23%)  4 0/93 (0.00%)  0
Urinary tract infection(gr 3/4 ANC) † 1  3/313 (0.96%)  3 4/325 (1.23%)  4 1/93 (1.08%)  1
Urinary tract infection(unknown ANC) † 1  2/313 (0.64%)  2 1/325 (0.31%)  1 0/93 (0.00%)  0
Wound infection(gr 3/4 ANC) † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Injury, poisoning and procedural complications       
Aortic injury † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Bruising † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Dermatitis radiation † 1  4/313 (1.28%)  5 15/325 (4.62%)  27 0/93 (0.00%)  0
Fracture † 1  2/313 (0.64%)  3 0/325 (0.00%)  0 1/93 (1.08%)  1
Intraoperative renal injury † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Radiation recall reaction (dermatologic) † 1  61/313 (19.49%)  93 90/325 (27.69%)  148 24/93 (25.81%)  42
Vascular access complication † 1  5/313 (1.60%)  5 1/325 (0.31%)  1 2/93 (2.15%)  2
Investigations       
Activated partial throm time prolonged † 1  2/313 (0.64%)  2 3/325 (0.92%)  3 2/93 (2.15%)  2
Alanine aminotransferase increased † 1  1/313 (0.32%)  1 6/325 (1.85%)  12 1/93 (1.08%)  1
Alkaline phosphatase increased † 1  4/313 (1.28%)  6 6/325 (1.85%)  11 2/93 (2.15%)  2
Aspartate aminotransferase increased † 1  2/313 (0.64%)  2 7/325 (2.15%)  12 1/93 (1.08%)  1
Blood bilirubin increased † 1  0/313 (0.00%)  0 1/325 (0.31%)  2 2/93 (2.15%)  2
CD4 lymphocytes decreased † 1  3/313 (0.96%)  6 8/325 (2.46%)  11 1/93 (1.08%)  1
Cardiac troponin I increased † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Cardiac troponin T increased † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Creatinine increased † 1  84/313 (26.84%)  155 91/325 (28.00%)  168 20/93 (21.51%)  37
Electrocardiogram QTc interval prolonged † 1  0/313 (0.00%)  0 0/325 (0.00%)  0 1/93 (1.08%)  1
INR increased † 1  1/313 (0.32%)  1 1/325 (0.31%)  1 0/93 (0.00%)  0
Laboratory test abnormal † 1  4/313 (1.28%)  6 3/325 (0.92%)  6 1/93 (1.08%)  2
Leukocyte count decreased † 1  219/313 (69.97%)  480 236/325 (72.62%)  559 73/93 (78.49%)  174
Lipase increased † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Lymphocyte count decreased † 1  38/313 (12.14%)  68 52/325 (16.00%)  109 21/93 (22.58%)  34
Neutrophil count decreased † 1  213/313 (68.05%)  411 240/325 (73.85%)  530 71/93 (76.34%)  168
Platelet count decreased † 1  63/313 (20.13%)  96 76/325 (23.38%)  127 21/93 (22.58%)  38
Serum cholesterol increased † 1  1/313 (0.32%)  1 1/325 (0.31%)  1 0/93 (0.00%)  0
Weight gain † 1  0/313 (0.00%)  0 2/325 (0.62%)  2 0/93 (0.00%)  0
Weight loss † 1  120/313 (38.34%)  236 119/325 (36.62%)  227 41/93 (44.09%)  86
Metabolism and nutrition disorders       
Acidosis † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 1/93 (1.08%)  1
Anorexia † 1  27/313 (8.63%)  43 30/325 (9.23%)  44 15/93 (16.13%)  17
Blood glucose increased † 1  20/313 (6.39%)  30 28/325 (8.62%)  58 7/93 (7.53%)  15
Blood uric acid increased † 1  2/313 (0.64%)  2 1/325 (0.31%)  1 0/93 (0.00%)  0
Dehydration † 1  105/313 (33.55%)  158 108/325 (33.23%)  178 34/93 (36.56%)  59
Glucose intolerance † 1  0/313 (0.00%)  0 0/325 (0.00%)  0 1/93 (1.08%)  1
Iron overload † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Obesity † 1  0/313 (0.00%)  0 2/325 (0.62%)  5 1/93 (1.08%)  4
Serum albumin decreased † 1  13/313 (4.15%)  14 14/325 (4.31%)  28 5/93 (5.38%)  6
Serum calcium decreased † 1  5/313 (1.60%)  6 17/325 (5.23%)  25 4/93 (4.30%)  4
Serum calcium increased † 1  1/313 (0.32%)  2 1/325 (0.31%)  2 0/93 (0.00%)  0
Serum glucose decreased † 1  1/313 (0.32%)  1 3/325 (0.92%)  4 0/93 (0.00%)  0
Serum magnesium decreased † 1  21/313 (6.71%)  32 28/325 (8.62%)  52 9/93 (9.68%)  19
Serum magnesium increased † 1  1/313 (0.32%)  1 2/325 (0.62%)  2 0/93 (0.00%)  0
Serum phosphate decreased † 1  4/313 (1.28%)  5 7/325 (2.15%)  8 4/93 (4.30%)  4
Serum potassium decreased † 1  27/313 (8.63%)  31 44/325 (13.54%)  60 15/93 (16.13%)  20
Serum potassium increased † 1  4/313 (1.28%)  4 6/325 (1.85%)  9 2/93 (2.15%)  2
Serum sodium decreased † 1  34/313 (10.86%)  45 40/325 (12.31%)  66 10/93 (10.75%)  15
Serum sodium increased † 1  1/313 (0.32%)  1 3/325 (0.92%)  3 0/93 (0.00%)  0
Serum triglycerides increased † 1  1/313 (0.32%)  1 2/325 (0.62%)  2 0/93 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  0/313 (0.00%)  0 6/325 (1.85%)  8 1/93 (1.08%)  1
Arthritis † 1  0/313 (0.00%)  0 1/325 (0.31%)  4 0/93 (0.00%)  0
Back pain † 1  7/313 (2.24%)  19 11/325 (3.38%)  18 4/93 (4.30%)  7
Bone pain † 1  0/313 (0.00%)  0 2/325 (0.62%)  3 1/93 (1.08%)  1
Chest wall pain † 1  1/313 (0.32%)  2 7/325 (2.15%)  10 3/93 (3.23%)  5
Muscle weakness † 1  10/313 (3.19%)  12 9/325 (2.77%)  11 3/93 (3.23%)  5
Muscle weakness lower limb † 1  1/313 (0.32%)  1 2/325 (0.62%)  5 1/93 (1.08%)  1
Musculoskeletal disorder † 1  1/313 (0.32%)  1 1/325 (0.31%)  2 0/93 (0.00%)  0
Myalgia † 1  1/313 (0.32%)  1 5/325 (1.54%)  6 0/93 (0.00%)  0
Neck pain † 1  2/313 (0.64%)  2 1/325 (0.31%)  1 0/93 (0.00%)  0
Pain in extremity † 1  0/313 (0.00%)  0 5/325 (1.54%)  10 0/93 (0.00%)  0
Nervous system disorders       
Depressed level of consciousness † 1  1/313 (0.32%)  1 1/325 (0.31%)  2 0/93 (0.00%)  0
Dizziness † 1  13/313 (4.15%)  20 17/325 (5.23%)  26 7/93 (7.53%)  8
Dysgeusia † 1  4/313 (1.28%)  6 7/325 (2.15%)  13 4/93 (4.30%)  6
Encephalopathy † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Facial muscle weakness † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Facial nerve disorder † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Headache † 1  12/313 (3.83%)  15 14/325 (4.31%)  30 3/93 (3.23%)  4
Intracranial hemorrhage † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Ischemia cerebrovascular † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 1/93 (1.08%)  1
Memory impairment † 1  2/313 (0.64%)  2 2/325 (0.62%)  2 0/93 (0.00%)  0
Neuralgia † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Neurological disorder NOS † 1  1/313 (0.32%)  1 3/325 (0.92%)  4 0/93 (0.00%)  0
Peripheral motor neuropathy † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 1/93 (1.08%)  1
Peripheral sensory neuropathy † 1  55/313 (17.57%)  113 60/325 (18.46%)  134 20/93 (21.51%)  36
Radiculitis brachial † 1  0/313 (0.00%)  0 1/325 (0.31%)  2 0/93 (0.00%)  0
Seizure † 1  0/313 (0.00%)  0 2/325 (0.62%)  2 0/93 (0.00%)  0
Syncope † 1  10/313 (3.19%)  11 8/325 (2.46%)  11 3/93 (3.23%)  3
Syncope vasovagal † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Tremor † 1  1/313 (0.32%)  1 3/325 (0.92%)  5 0/93 (0.00%)  0
Psychiatric disorders       
Agitation † 1  0/313 (0.00%)  0 2/325 (0.62%)  2 0/93 (0.00%)  0
Anxiety † 1  5/313 (1.60%)  9 13/325 (4.00%)  19 6/93 (6.45%)  6
Confusion † 1  2/313 (0.64%)  2 2/325 (0.62%)  2 1/93 (1.08%)  1
Depression † 1  9/313 (2.88%)  13 7/325 (2.15%)  11 2/93 (2.15%)  2
Insomnia † 1  12/313 (3.83%)  18 11/325 (3.38%)  22 4/93 (4.30%)  7
Renal and urinary disorders       
Bladder hemorrhage † 1  0/313 (0.00%)  0 0/325 (0.00%)  0 1/93 (1.08%)  1
Cystitis † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 1/93 (1.08%)  1
Glomerular filtration rate decreased † 1  2/313 (0.64%)  2 1/325 (0.31%)  1 1/93 (1.08%)  1
Proteinuria † 1  1/313 (0.32%)  1 1/325 (0.31%)  1 1/93 (1.08%)  1
Renal failure † 1  2/313 (0.64%)  5 3/325 (0.92%)  4 1/93 (1.08%)  1
Urinary frequency † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Urinary incontinence † 1  0/313 (0.00%)  0 2/325 (0.62%)  2 0/93 (0.00%)  0
Urinary retention † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Urogenital disorder † 1  6/313 (1.92%)  10 5/325 (1.54%)  6 0/93 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome † 1  1/313 (0.32%)  1 1/325 (0.31%)  2 0/93 (0.00%)  0
Allergic rhinitis † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 1/93 (1.08%)  4
Apnea † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Bronchopulmonary hemorrhage † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Bronchospasm † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 1/93 (1.08%)  1
Cough † 1  35/313 (11.18%)  64 37/325 (11.38%)  81 10/93 (10.75%)  20
Dyspnea † 1  137/313 (43.77%)  293 164/325 (50.46%)  354 44/93 (47.31%)  92
Epistaxis † 1  0/313 (0.00%)  0 2/325 (0.62%)  3 0/93 (0.00%)  0
Hiccups † 1  0/313 (0.00%)  0 4/325 (1.23%)  8 1/93 (1.08%)  1
Hypoxia † 1  1/313 (0.32%)  1 13/325 (4.00%)  15 1/93 (1.08%)  1
Laryngeal hemorrhage † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Laryngeal pain † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Pharyngeal mucositis (clin exam) † 1  1/313 (0.32%)  1 2/325 (0.62%)  3 0/93 (0.00%)  0
Pharyngeal mucositis (funct/sympt) † 1  0/313 (0.00%)  0 2/325 (0.62%)  2 0/93 (0.00%)  0
Pharyngolaryngeal pain † 1  1/313 (0.32%)  1 3/325 (0.92%)  4 2/93 (2.15%)  2
Pleural effusion † 1  0/313 (0.00%)  0 2/325 (0.62%)  2 2/93 (2.15%)  3
Pneumonitis † 1  17/313 (5.43%)  22 12/325 (3.69%)  24 7/93 (7.53%)  7
Pulmonary fibrosis † 1  0/313 (0.00%)  0 0/325 (0.00%)  0 1/93 (1.08%)  1
Respiratory disorder † 1  4/313 (1.28%)  8 6/325 (1.85%)  6 0/93 (0.00%)  0
Respiratory tract hemorrhage † 1  0/313 (0.00%)  0 2/325 (0.62%)  2 0/93 (0.00%)  0
Sinus pain † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Tracheal mucositis (clin exam) † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Voice alteration † 1  0/313 (0.00%)  0 2/325 (0.62%)  3 0/93 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia † 1  24/313 (7.67%)  54 31/325 (9.54%)  68 6/93 (6.45%)  14
Dry skin † 1  2/313 (0.64%)  3 3/325 (0.92%)  6 0/93 (0.00%)  0
Erythema multiforme † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Nail disorder † 1  0/313 (0.00%)  0 1/325 (0.31%)  2 0/93 (0.00%)  0
Pruritus † 1  1/313 (0.32%)  2 3/325 (0.92%)  5 0/93 (0.00%)  0
Rash acneiform † 1  3/313 (0.96%)  4 2/325 (0.62%)  3 1/93 (1.08%)  1
Rash desquamating † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 1/93 (1.08%)  2
Skin disorder † 1  1/313 (0.32%)  1 6/325 (1.85%)  8 1/93 (1.08%)  1
Skin ulceration † 1  0/313 (0.00%)  0 1/325 (0.31%)  1 0/93 (0.00%)  0
Sweating † 1  0/313 (0.00%)  0 2/325 (0.62%)  2 0/93 (0.00%)  0
Vascular disorders       
Flushing † 1  1/313 (0.32%)  2 2/325 (0.62%)  2 0/93 (0.00%)  0
Hemorrhage † 1  0/313 (0.00%)  0 0/325 (0.00%)  0 1/93 (1.08%)  1
Hot flashes † 1  0/313 (0.00%)  0 3/325 (0.92%)  6 0/93 (0.00%)  0
Hypertension † 1  13/313 (4.15%)  29 17/325 (5.23%)  32 2/93 (2.15%)  2
Hypotension † 1  10/313 (3.19%)  12 14/325 (4.31%)  20 1/93 (1.08%)  1
Phlebitis † 1  1/313 (0.32%)  1 0/325 (0.00%)  0 0/93 (0.00%)  0
Thrombosis † 1  13/313 (4.15%)  19 6/325 (1.85%)  9 7/93 (7.53%)  8
Vascular disorder † 1  2/313 (0.64%)  2 2/325 (0.62%)  2 1/93 (1.08%)  1
1
Term from vocabulary, MedDRA 5
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Steven Schild
Organization: Mayo Clinic
Phone: 480-301-9692
EMail: sschild@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00632853    
Other Study ID Numbers: CALGB-30610
CALGB-30610 ( Other Identifier: Cancer and Leukemia Group B )
RTOG 0538 ( Other Identifier: Radiation Therapy Oncology Group )
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000588879 ( Registry Identifier: Physician Data Query )
NCI-2009-00470 ( Registry Identifier: NCI Clinical Trials Reporting Program )
First Submitted: March 8, 2008
First Posted: March 11, 2008
Results First Submitted: April 28, 2023
Results First Posted: June 12, 2023
Last Update Posted: June 12, 2023