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Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma

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: NCT01730950
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : March 17, 2020
Last Update Posted : December 29, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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 Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Interventions Biological: bevacizumab
Radiation: radiation therapy
Enrollment 182
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab Bevacizumab + RT
Hide Arm/Group Description Bevacizumab (IV 10mg/kg) every 2 weeks until disease progression. Radiation therapy (35Gy in 10 fractions of 3.5 Gy) with bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
Period Title: Overall Study
Started 90 92
Eligible Population 84 86
Adverse Event Population [1] 76 83
Response Population [2] 78 77
6-month Progression-free Analysis [3] 79 81
Delayed Toxicity Population [4] 0 83
Completed [5] 84 86
Not Completed 6 6
Reason Not Completed
Protocol Violation             6             6
[1]
Eligible participants who started protocol treatment
[2]
Eligible participants with response evaluations
[3]
Eligible participants with data at 6 months
[4]
Eligible participants on RT arm who started RT and were alive at least 91 days from the start of RT
[5]
Subjects contributing data to results are considered to have completed the study.
Arm/Group Title Bevacizumab Bevacizumab + RT Total
Hide Arm/Group Description Bevacizumab (IV 10mg/kg) every 2 weeks until disease progression. Radiation therapy (35Gy in 10 fractions of 3.5 Gy) with bevacizumab (IV 10mg/kg) every 2 weeks until disease progression. Total of all reporting groups
Overall Number of Baseline Participants 84 86 170
Hide Baseline Analysis Population Description
Eligible participants
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 84 participants 86 participants 170 participants
57
(25 to 87)
60
(28 to 81)
59
(25 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 86 participants 170 participants
Female
38
  45.2%
43
  50.0%
81
  47.6%
Male
46
  54.8%
43
  50.0%
89
  52.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 86 participants 170 participants
Hispanic or Latino
8
   9.5%
3
   3.5%
11
   6.5%
Not Hispanic or Latino
72
  85.7%
81
  94.2%
153
  90.0%
Unknown or Not Reported
4
   4.8%
2
   2.3%
6
   3.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 86 participants 170 participants
American Indian or Alaska Native
4
   4.8%
0
   0.0%
4
   2.4%
Asian
6
   7.1%
2
   2.3%
8
   4.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   3.6%
2
   2.3%
5
   2.9%
White
66
  78.6%
75
  87.2%
141
  82.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
   6.0%
7
   8.1%
12
   7.1%
Karnofsky Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 86 participants 170 participants
60
3
   3.6%
8
   9.3%
11
   6.5%
70-80
42
  50.0%
41
  47.7%
83
  48.8%
90-100
39
  46.4%
37
  43.0%
76
  44.7%
[1]
Measure Description: 60 = Requires occasional assistance, but is able to care for most personal needs; 70 = Cares for self; unable to carry on normal activity or to do active work; 80 = Normal activity with effort; some signs or symptoms of disease; 90 = Able to carry on normal activity, minor signs or symptoms of disease; 100 = Normal no complaints; no evidence of disease.
Neurologic Function  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 86 participants 170 participants
No symptoms
21
  25.0%
24
  27.9%
45
  26.5%
Minor symptoms
40
  47.6%
36
  41.9%
76
  44.7%
Moderate symptoms (fully active)
17
  20.2%
15
  17.4%
32
  18.8%
Moderate symptoms (required assistance)
6
   7.1%
9
  10.5%
15
   8.8%
Severe symptoms
0
   0.0%
2
   2.3%
2
   1.2%
Surgery for Initial Brain Tumor  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 86 participants 170 participants
Biopsy only
8
   9.5%
7
   8.1%
15
   8.8%
Subtotal resection
20
  23.8%
25
  29.1%
45
  26.5%
Gross total resection
56
  66.7%
52
  60.5%
108
  63.5%
Other
0
   0.0%
2
   2.3%
2
   1.2%
Recent Resection  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 86 participants 170 participants
No / biopsy only
49
  58.3%
57
  66.3%
106
  62.4%
Yes
35
  41.7%
29
  33.7%
64
  37.6%
Histologic Tumor Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 86 participants 170 participants
Glioblastoma (WHO Grade IV)
79
  94.0%
82
  95.3%
161
  94.7%
Gliosarcoma
2
   2.4%
2
   2.3%
4
   2.4%
Other
3
   3.6%
2
   2.3%
5
   2.9%
1.Primary Outcome
Title Overall Survival
Hide Description Survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times will be compared between the arms, which is reported in the statistical analysis results. Eighteen-month rates are provided. Analysis was planned to occur when 135 deaths were reported.
Time Frame From randomization to last follow-up. Maximum follow-up at time of analysis was 52.8 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title Bevacizumab Bevacizumab + RT
Hide Arm/Group Description:
Bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
Radiation therapy (35 Gy in 10 fractions of 3.5 Gy) with bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
Overall Number of Participants Analyzed 84 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.1
(15.2 to 35.0)
21.6
(12.1 to 31.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab, Bevacizumab + RT
Comments Null hypothesis: median survival time for both arms is 9 months; alternative hypothesis: participants receiving radiation therapy plus bevacizumab will have an improvement in median survival time to 13 months. One hundred and sixty eligible participants provides 80% power to detect a 31% reduction in the hazard ratio to 0.69 at a one-sided significance level of 0.10. Analysis was planned to occur when 135 deaths were reported, expected to occur 16 to 21 months after trial closure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Log Rank
Comments Two-side significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.70 to 1.38
Estimation Comments Reference level = Bevacizumab
2.Secondary Outcome
Title Percentage of Participants With Complete or Partial Best Response
Hide Description

Best observed objective response determined by serial measures of the product of the two largest perpendicular cross-sectional diameters using MacDonald Criteria:

  • Complete Response (CR): complete disappearance of measurable enhancing lesion sustained ≥ 4 weeks; and no new lesions; and no corticosteroids.
  • Partial Response (PR): ≥ 50% decrease from baseline in sum of products of the measurable enhancing lesion sustained ≥ 4 weeks; and no new lesions; and stable/reduced corticosteroid dose.
  • Progression (P): ≥ 25% increase in sum of products of enhancing lesions (patient has not had steroid dose decreased since the last evaluation period); or any new lesions. A concomitant decrease in steroid dose rules out progression designation during initial 12 weeks after radiotherapy.
  • Stable Disease (SD): all of following: does not qualify for CR, PR, or P; receiving stable/decreasing doses of steroids.

Estimated using an exact binomial distribution.
Time Frame From randomization to last follow-up. Maximum follow-up at time of analysis was 52.8 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants with response evaluations
Arm/Group Title Bevacizumab Bevacizumab + RT
Hide Arm/Group Description:
Bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
Radiation therapy (35 Gy in 10 fractions of 3.5 Gy) with bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
Overall Number of Participants Analyzed 78 77
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.5
(12.2 to 31.2)
29.9
(20.0 to 41.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Chi-squared
Comments Two-sided significance level = 0.05
3.Secondary Outcome
Title Percentage of Participants Progression-free at 6 Months
Hide Description

Best observed objective response determined by serial measures of the product of the two largest perpendicular cross-sectional diameters using MacDonald Criteria:

Progression (P): ≥ 25% increase in sum of products of enhancing lesions (patient has not had steroid dose decreased since the last evaluation period); or any new lesions. A concomitant decrease in steroid dose rules out progression designation during initial 12 weeks after radiotherapy. Progression-free at 6 months means patient alive without progression at 6 months.
Time Frame From randomization to six months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants with data at six months
Arm/Group Title Bevacizumab Bevacizumab + RT
Hide Arm/Group Description:
Bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
Radiation therapy (35 Gy in 10 fractions of 3.5 Gy) with bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
Overall Number of Participants Analyzed 79 81
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.1
(19.4 to 40.4)
54.3
(42.9 to 65.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab, Bevacizumab + RT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Chi-squared
Comments Two-sided significance level = 0.05
4.Secondary Outcome
Title Progression-free Survival
Hide Description Progression using using MacDonald Criteria is defined as ≥ 25% increase from baseline in sum of products of the two largest perpendicular cross-sectional diameters of enhancing lesions (patient has not had steroid dose decreased since the last evaluation period); or any new lesions. A concomitant decrease in steroid dose rules out progression designation during initial 12 weeks after radiotherapy. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times will be compared between the arms, which is reported in the statistical analysis results. Eighteen-month rates are provided. Analysis was planned to occur when 135 deaths were reported.
Time Frame From randomization to last follow-up. Maximum follow-up at time of analysis was 52.8 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title Bevacizumab Bevacizumab + RT
Hide Arm/Group Description:
Bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
Radiation therapy (35 Gy in 10 fractions of 3.5 Gy) with bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
Overall Number of Participants Analyzed 84 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.9
(2.6 to 15.2)
7.9
(1.9 to 13.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab, Bevacizumab + RT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Log Rank
Comments Two-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.53 to 1.00
Estimation Comments Reference level = Bevacizumab
5.Secondary Outcome
Title Percentage of Participants With Grade 3+ Central Nervous System (CNS) Toxicity Within 90 Days of Start of Radiation Therapy Reported as Possibly/Probably/Definitely Related to Protocol Treatment
Hide Description Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 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 randomization to last follow-up. Maximum follow-up at time of analysis was 52.8 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants on the radiation therapy arm who started radiation therapy
Arm/Group Title Bevacizumab + RT
Hide Arm/Group Description:
Radiation therapy (35 Gy in 10 fractions of 3.5 Gy) with bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
Overall Number of Participants Analyzed 83
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.8
(1.3 to 11.9)
6.Secondary Outcome
Title Number of Participants With Grade 3+ CNS Toxicity More Than 90 Days of Start of Radiation Therapy Reported as Possibly/Probably/Definitely Related to Protocol Treatment
Hide Description Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 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. Estimated using an exact binomial distribution together with 95% confidence interval. The difference between the two groups will be tested using a chi square test.
Time Frame From 91 days after the start of radiation therapy to end of follow-up. Maximum follow-up at the time of analysis is 58.2 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants on the radiation therapy arm who started radiation therapy and were alive at least 91 days from the start of radiation therapy
Arm/Group Title Bevacizumab + RT
Hide Arm/Group Description:
Radiation therapy (35 Gy in 10 fractions of 3.5 Gy) with bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
Overall Number of Participants Analyzed 83
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Adverse events were to be reported every 2 months for first year, every 6 months for second year, then annually until study completion. Maximum follow-up at time of analysis was 52.8 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab Bevacizumab + RT
Hide Arm/Group Description Bevacizumab (IV 10mg/kg) every 2 weeks until disease progression. Radiation therapy (35Gy in 10 fractions of 3.5 Gy) with bevacizumab (IV 10mg/kg) every 2 weeks until disease progression.
All-Cause Mortality
Bevacizumab Bevacizumab + RT
Affected / at Risk (%) Affected / at Risk (%)
Total   4/76 (5.26%)   8/83 (9.64%) 
Hide Serious Adverse Events
Bevacizumab Bevacizumab + RT
Affected / at Risk (%) Affected / at Risk (%)
Total   27/76 (35.53%)   29/83 (34.94%) 
Blood and lymphatic system disorders     
Anemia * 1  1/76 (1.32%)  0/83 (0.00%) 
Blood and lymphatic system disorders - Other * 1  1/76 (1.32%)  0/83 (0.00%) 
Thrombotic thrombocytopenic purpura * 1  1/76 (1.32%)  0/83 (0.00%) 
Cardiac disorders     
Sinus bradycardia * 1  1/76 (1.32%)  0/83 (0.00%) 
Eye disorders     
Blurred vision * 1  1/76 (1.32%)  0/83 (0.00%) 
Gastrointestinal disorders     
Colonic obstruction * 1  0/76 (0.00%)  1/83 (1.20%) 
Colonic perforation * 1  0/76 (0.00%)  1/83 (1.20%) 
Nausea * 1  1/76 (1.32%)  1/83 (1.20%) 
Upper gastrointestinal hemorrhage * 1  0/76 (0.00%)  1/83 (1.20%) 
Vomiting * 1  1/76 (1.32%)  0/83 (0.00%) 
General disorders     
Death NOS * 1  1/76 (1.32%)  2/83 (2.41%) 
Edema limbs * 1  1/76 (1.32%)  0/83 (0.00%) 
Fatigue * 1  1/76 (1.32%)  1/83 (1.20%) 
General disorders and administration site conditions - Other * 1  0/76 (0.00%)  1/83 (1.20%) 
Neck edema * 1  1/76 (1.32%)  0/83 (0.00%) 
Non-cardiac chest pain * 1  1/76 (1.32%)  0/83 (0.00%) 
Pain * 1  1/76 (1.32%)  1/83 (1.20%) 
Sudden death NOS * 1  0/76 (0.00%)  1/83 (1.20%) 
Hepatobiliary disorders     
Cholecystitis * 1  0/76 (0.00%)  1/83 (1.20%) 
Infections and infestations     
Infections and infestations - Other * 1  1/76 (1.32%)  0/83 (0.00%) 
Lung infection * 1  2/76 (2.63%)  2/83 (2.41%) 
Sepsis * 1  1/76 (1.32%)  2/83 (2.41%) 
Urinary tract infection * 1  1/76 (1.32%)  1/83 (1.20%) 
Wound infection * 1  2/76 (2.63%)  1/83 (1.20%) 
Injury, poisoning and procedural complications     
Fall * 1  0/76 (0.00%)  2/83 (2.41%) 
Wound dehiscence * 1  1/76 (1.32%)  0/83 (0.00%) 
Investigations     
Investigations - Other * 1  1/76 (1.32%)  0/83 (0.00%) 
Metabolism and nutrition disorders     
Alkalosis * 1  1/76 (1.32%)  0/83 (0.00%) 
Dehydration * 1  1/76 (1.32%)  1/83 (1.20%) 
Hypokalemia * 1  1/76 (1.32%)  1/83 (1.20%) 
Hyponatremia * 1  1/76 (1.32%)  1/83 (1.20%) 
Metabolism and nutrition disorders - Other * 1  1/76 (1.32%)  0/83 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  2/76 (2.63%)  1/83 (1.20%) 
Generalized muscle weakness * 1  1/76 (1.32%)  3/83 (3.61%) 
Muscle weakness left-sided * 1  1/76 (1.32%)  1/83 (1.20%) 
Muscle weakness lower limb * 1  0/76 (0.00%)  1/83 (1.20%) 
Muscle weakness right-sided * 1  0/76 (0.00%)  1/83 (1.20%) 
Musculoskeletal deformity * 1  0/76 (0.00%)  1/83 (1.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other * 1  1/76 (1.32%)  1/83 (1.20%) 
Nervous system disorders     
Cerebrospinal fluid leakage * 1  0/76 (0.00%)  1/83 (1.20%) 
Cognitive disturbance * 1  1/76 (1.32%)  1/83 (1.20%) 
Encephalopathy * 1  3/76 (3.95%)  2/83 (2.41%) 
Headache * 1  1/76 (1.32%)  0/83 (0.00%) 
Intracranial hemorrhage * 1  1/76 (1.32%)  1/83 (1.20%) 
Seizure * 1  5/76 (6.58%)  7/83 (8.43%) 
Stroke * 1  1/76 (1.32%)  0/83 (0.00%) 
Syncope * 1  0/76 (0.00%)  2/83 (2.41%) 
Tremor * 1  1/76 (1.32%)  0/83 (0.00%) 
Psychiatric disorders     
Confusion * 1  1/76 (1.32%)  1/83 (1.20%) 
Renal and urinary disorders     
Proteinuria * 1  1/76 (1.32%)  2/83 (2.41%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration * 1  0/76 (0.00%)  2/83 (2.41%) 
Dyspnea * 1  1/76 (1.32%)  0/83 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  1/76 (1.32%)  0/83 (0.00%) 
Vascular disorders     
Hematoma * 1  2/76 (2.63%)  1/83 (1.20%) 
Hypertension * 1  1/76 (1.32%)  0/83 (0.00%) 
Hypotension * 1  1/76 (1.32%)  0/83 (0.00%) 
Thromboembolic event * 1  2/76 (2.63%)  0/83 (0.00%) 
Vasculitis * 1  1/76 (1.32%)  0/83 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab Bevacizumab + RT
Affected / at Risk (%) Affected / at Risk (%)
Total   70/76 (92.11%)   73/83 (87.95%) 
Blood and lymphatic system disorders     
Anemia * 1  12/76 (15.79%)  10/83 (12.05%) 
Blood and lymphatic system disorders - Other * 1  7/76 (9.21%)  1/83 (1.20%) 
Eye disorders     
Blurred vision * 1  9/76 (11.84%)  10/83 (12.05%) 
Eye disorders - Other * 1  5/76 (6.58%)  7/83 (8.43%) 
Gastrointestinal disorders     
Abdominal pain * 1  5/76 (6.58%)  3/83 (3.61%) 
Constipation * 1  12/76 (15.79%)  8/83 (9.64%) 
Diarrhea * 1  10/76 (13.16%)  12/83 (14.46%) 
Dyspepsia * 1  5/76 (6.58%)  4/83 (4.82%) 
Nausea * 1  20/76 (26.32%)  14/83 (16.87%) 
Vomiting * 1  7/76 (9.21%)  7/83 (8.43%) 
General disorders     
Edema limbs * 1  15/76 (19.74%)  9/83 (10.84%) 
Fatigue * 1  34/76 (44.74%)  47/83 (56.63%) 
Gait disturbance * 1  14/76 (18.42%)  16/83 (19.28%) 
General disorders and administration site conditions - Other * 1  6/76 (7.89%)  2/83 (2.41%) 
Pain * 1  10/76 (13.16%)  12/83 (14.46%) 
Infections and infestations     
Infections and infestations - Other * 1  4/76 (5.26%)  5/83 (6.02%) 
Urinary tract infection * 1  6/76 (7.89%)  8/83 (9.64%) 
Injury, poisoning and procedural complications     
Bruising * 1  5/76 (6.58%)  4/83 (4.82%) 
Fall * 1  8/76 (10.53%)  6/83 (7.23%) 
Investigations     
Alanine aminotransferase increased * 1  7/76 (9.21%)  11/83 (13.25%) 
Aspartate aminotransferase increased * 1  4/76 (5.26%)  6/83 (7.23%) 
Lymphocyte count decreased * 1  11/76 (14.47%)  7/83 (8.43%) 
Neutrophil count decreased * 1  8/76 (10.53%)  4/83 (4.82%) 
Platelet count decreased * 1  21/76 (27.63%)  12/83 (14.46%) 
Weight loss * 1  4/76 (5.26%)  8/83 (9.64%) 
White blood cell decreased * 1  9/76 (11.84%)  7/83 (8.43%) 
Metabolism and nutrition disorders     
Anorexia * 1  8/76 (10.53%)  10/83 (12.05%) 
Hyperglycemia * 1  14/76 (18.42%)  12/83 (14.46%) 
Hypoalbuminemia * 1  7/76 (9.21%)  2/83 (2.41%) 
Hypocalcemia * 1  6/76 (7.89%)  3/83 (3.61%) 
Hypokalemia * 1  7/76 (9.21%)  3/83 (3.61%) 
Hyponatremia * 1  5/76 (6.58%)  6/83 (7.23%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  4/76 (5.26%)  8/83 (9.64%) 
Back pain * 1  5/76 (6.58%)  8/83 (9.64%) 
Generalized muscle weakness * 1  9/76 (11.84%)  5/83 (6.02%) 
Muscle weakness left-sided * 1  8/76 (10.53%)  5/83 (6.02%) 
Muscle weakness lower limb * 1  6/76 (7.89%)  5/83 (6.02%) 
Muscle weakness right-sided * 1  4/76 (5.26%)  5/83 (6.02%) 
Muscle weakness upper limb * 1  4/76 (5.26%)  3/83 (3.61%) 
Musculoskeletal and connective tissue disorder - Other * 1  6/76 (7.89%)  3/83 (3.61%) 
Myalgia * 1  4/76 (5.26%)  4/83 (4.82%) 
Pain in extremity * 1  6/76 (7.89%)  3/83 (3.61%) 
Nervous system disorders     
Ataxia * 1  4/76 (5.26%)  2/83 (2.41%) 
Cognitive disturbance * 1  8/76 (10.53%)  4/83 (4.82%) 
Dizziness * 1  12/76 (15.79%)  13/83 (15.66%) 
Dysarthria * 1  5/76 (6.58%)  4/83 (4.82%) 
Dysphasia * 1  18/76 (23.68%)  11/83 (13.25%) 
Headache * 1  37/76 (48.68%)  31/83 (37.35%) 
Lethargy * 1  4/76 (5.26%)  1/83 (1.20%) 
Memory impairment * 1  12/76 (15.79%)  17/83 (20.48%) 
Nervous system disorders - Other * 1  10/76 (13.16%)  8/83 (9.64%) 
Paresthesia * 1  4/76 (5.26%)  5/83 (6.02%) 
Peripheral sensory neuropathy * 1  8/76 (10.53%)  3/83 (3.61%) 
Seizure * 1  11/76 (14.47%)  14/83 (16.87%) 
Psychiatric disorders     
Anxiety * 1  13/76 (17.11%)  8/83 (9.64%) 
Confusion * 1  11/76 (14.47%)  12/83 (14.46%) 
Depression * 1  8/76 (10.53%)  9/83 (10.84%) 
Insomnia * 1  9/76 (11.84%)  12/83 (14.46%) 
Renal and urinary disorders     
Hematuria * 1  3/76 (3.95%)  7/83 (8.43%) 
Proteinuria * 1  16/76 (21.05%)  20/83 (24.10%) 
Renal and urinary disorders - Other * 1  4/76 (5.26%)  3/83 (3.61%) 
Urinary incontinence * 1  7/76 (9.21%)  4/83 (4.82%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis * 1  5/76 (6.58%)  3/83 (3.61%) 
Cough * 1  8/76 (10.53%)  15/83 (18.07%) 
Dyspnea * 1  7/76 (9.21%)  9/83 (10.84%) 
Epistaxis * 1  1/76 (1.32%)  8/83 (9.64%) 
Hoarseness * 1  6/76 (7.89%)  6/83 (7.23%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  4/76 (5.26%)  11/83 (13.25%) 
Dry skin * 1  4/76 (5.26%)  5/83 (6.02%) 
Pruritus * 1  5/76 (6.58%)  2/83 (2.41%) 
Rash acneiform * 1  4/76 (5.26%)  2/83 (2.41%) 
Rash maculo-papular * 1  3/76 (3.95%)  5/83 (6.02%) 
Skin and subcutaneous tissue disorders - Other * 1  4/76 (5.26%)  7/83 (8.43%) 
Vascular disorders     
Hypertension * 1  33/76 (43.42%)  29/83 (34.94%) 
Thromboembolic event * 1  6/76 (7.89%)  4/83 (4.82%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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 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: NCT01730950    
Obsolete Identifiers: NCT02671981
Other Study ID Numbers: RTOG-1205
NCI-2012-01732 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
U10CA021661 ( U.S. NIH Grant/Contract )
First Submitted: November 15, 2012
First Posted: November 21, 2012
Results First Submitted: February 20, 2020
Results First Posted: March 17, 2020
Last Update Posted: December 29, 2022