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Temozolomide and Radiation Therapy With or Without Cediranib Maleate in Treating Patients With Newly Diagnosed 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: NCT01062425
Recruitment Status : Active, not recruiting
First Posted : February 4, 2010
Results First Posted : September 19, 2016
Last Update Posted : January 2, 2020
Sponsor:
Collaborators:
NRG Oncology
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Adult Glioblastoma
Adult Gliosarcoma
Interventions Radiation: 3-Dimensional Conformal Radiation Therapy
Drug: Cediranib Maleate
Radiation: Intensity-Modulated Radiation Therapy
Other: Laboratory Biomarker Analysis
Other: Placebo Administration
Drug: Temozolomide
Enrollment 261
Recruitment Details  
Pre-assignment Details After patient registration, sites submitted tissue for central histology and methyltransferase (MGMT) gene methylation evaluation. If tissue was evaluable and a patient continued on study, then treatment arm was assigned. Two hundred sixty-one patients were registered, 103 did not continue to treatment assignment, 158 had treatment assigned.
Arm/Group Title Placebo, TMZ, and RT Cediranib, TMZ, and RT
Hide Arm/Group Description Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
Period Title: Overall Study
Started 55 103
Completed 52 [1] 97 [1]
Not Completed 3 6
Reason Not Completed
Protocol Violation             3             6
[1]
Randomized eligible subjects are considered to have completed the study.
Arm/Group Title Placebo, TMZ, and RT Cediranib, TMZ, and RT Total
Hide Arm/Group Description Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum Total of all reporting groups
Overall Number of Baseline Participants 52 97 149
Hide Baseline Analysis Population Description
All randomized and eligible patients.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 52 participants 97 participants 149 participants
59
(37 to 82)
61
(27 to 83)
60
(27 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 97 participants 149 participants
Female
24
  46.2%
44
  45.4%
68
  45.6%
Male
28
  53.8%
53
  54.6%
81
  54.4%
1.Primary Outcome
Title 6-month Progression-free Survival Rate
Hide Description Six-month progression-free survival is the rate of patients who have NOT progressed at six months, where progressive disease is defined as any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. Progression will be determined by central review of MRI exams, assessed using MacDonald criteria for progression versus response on 2D T1 and T2 weighted images.
Time Frame From randomization to 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized eligible patients with evaluable data at six months. (From the randomized eligible patients, 2 patients withdrew prior to 6 months and 1 did not have an evaluable scan on the placebo arm, while 4 withdrew before 6 months, 3 did not have an evaluable scan, and 2 did not receive protocol treatment on the cediranib arm.)
Arm/Group Title Placebo, TMZ, and RT Cediranib, TMZ, and RT
Hide Arm/Group Description:
Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
Overall Number of Participants Analyzed 49 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.5
(12.5 to 36.5)
46.6
(36.2 to 57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TMZ, and RT, Cediranib, TMZ, and RT
Comments The null hypothesis was that the 6m PFS rates for both arms are 50%, and the alternative hypothesis was that patients receiving the experimental regimen would have a 6-month PFS rate of 66%. With 150 eligible patients, there would be an 80% statistical power to detect the 16% absolute increase in 6m PFS at a significance level of 0.15, using a one-sided Z test for two proportions.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments One-sided test with significance level of 0.15.
Method Z-test
Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS will be estimated using the Kaplan-Meier method and differences between treatment arms will be tested using the log rank test. Multivariate analyses with the Cox proportional hazard model for OS will be performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors.
Time Frame From randomization to time of death due to any cause. Patients are followed until death. Analysis occurs after all patients have been potentially followed for six months.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and eligible patients.
Arm/Group Title Placebo, TMZ, and RT Cediranib, TMZ, and RT
Hide Arm/Group Description:
Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
Overall Number of Participants Analyzed 52 97
Median (95% Confidence Interval)
Unit of Measure: Months
13.8
(9.6 to 18.9)
14.5
(12.3 to 19.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TMZ, and RT, Cediranib, TMZ, and RT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments Significance level 0.05, two-sided test.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.6 to 1.24
Estimation Comments Placebo is the reference arm for the hazard ratio.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TMZ, and RT, Cediranib, TMZ, and RT
Comments Multivariate analysis with the Cox proportional hazard model for overall survival was performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors. The covariates evaluated for the multivariate models were assigned protocol treatment, MGMT methylation status, and RPA risk class.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.648
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.62 to 1.34
Estimation Comments Placebo is reference level for the hazard ratio.
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival time is defined as time from randomization to date of first progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without progression are censored at the date of last contact. Progression is defined as any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.
Time Frame From randomization to time of first progression or death due to any cause. Patients are followed until death. Analysis occurs after all patients have been potentially followed for six months.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and eligible patients.
Arm/Group Title Placebo, TMZ, and RT Cediranib, TMZ, and RT
Hide Arm/Group Description:
Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
Overall Number of Participants Analyzed 52 97
Median (95% Confidence Interval)
Unit of Measure: Months
2.7
(2.5 to 3.7)
6.2
(4.5 to 8.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TMZ, and RT, Cediranib, TMZ, and RT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments Significance level 0.05, two-sided test.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.47 to 0.95
Estimation Comments Placebo is the reference arm for the hazard ratio.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TMZ, and RT, Cediranib, TMZ, and RT
Comments Multivariate analysis with the Cox proportional hazard model for progression-free survival was performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors. The covariates evaluated for the multivariate models were assigned protocol treatment, MGMT methylation status, and recursive partitioning analysis (RPA) risk class.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.46 to 0.97
Estimation Comments Placebo is the reference arm.
4.Secondary Outcome
Title Incidence of Grade 3+ Toxicities
Hide Description The number of patients with reported grade 3 and higher treatment-related toxicities as assessed by Common Terminology Criteria for Adverse Events version 4.0
Time Frame From randomization to six months.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and eligible patients who started protocol treatment.
Arm/Group Title Placebo, TMZ, and RT Cediranib, TMZ, and RT
Hide Arm/Group Description:
Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
Overall Number of Participants Analyzed 52 92
Measure Type: Number
Unit of Measure: participants
35 77
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TMZ, and RT, Cediranib, TMZ, and RT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments Significance level 0.05, two-sided test.
Method Chi-squared
Comments [Not Specified]
Time Frame Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Adverse Event Reporting Description All randomized and eligible patients who started protocol treatment.
 
Arm/Group Title Placebo, TMZ, and RT Cediranib, TMZ, and RT
Hide Arm/Group Description Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
All-Cause Mortality
Placebo, TMZ, and RT Cediranib, TMZ, and RT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo, TMZ, and RT Cediranib, TMZ, and RT
Affected / at Risk (%) Affected / at Risk (%)
Total   23/52 (44.23%)   53/92 (57.61%) 
Blood and lymphatic system disorders     
Anemia * 1  3/52 (5.77%)  4/92 (4.35%) 
Blood and lymphatic system disorders - Other * 1  1/52 (1.92%)  1/92 (1.09%) 
Bone marrow hypocellular * 1  0/52 (0.00%)  2/92 (2.17%) 
Febrile neutropenia * 1  1/52 (1.92%)  1/92 (1.09%) 
Leukocytosis * 1  1/52 (1.92%)  0/92 (0.00%) 
Cardiac disorders     
Atrial fibrillation * 1  0/52 (0.00%)  1/92 (1.09%) 
Endocrine disorders     
Hypothyroidism * 1  0/52 (0.00%)  1/92 (1.09%) 
Eye disorders     
Blurred vision * 1  0/52 (0.00%)  1/92 (1.09%) 
Gastrointestinal disorders     
Constipation * 1  0/52 (0.00%)  1/92 (1.09%) 
Diarrhea * 1  0/52 (0.00%)  6/92 (6.52%) 
Dry mouth * 1  0/52 (0.00%)  1/92 (1.09%) 
Hemorrhoidal hemorrhage * 1  0/52 (0.00%)  1/92 (1.09%) 
Nausea * 1  3/52 (5.77%)  4/92 (4.35%) 
Pancreatitis * 1  0/52 (0.00%)  1/92 (1.09%) 
Retroperitoneal hemorrhage * 1  1/52 (1.92%)  0/92 (0.00%) 
Vomiting * 1  2/52 (3.85%)  2/92 (2.17%) 
General disorders     
Chills * 1  0/52 (0.00%)  1/92 (1.09%) 
Death NOS * 1  2/52 (3.85%)  1/92 (1.09%) 
Edema limbs * 1  1/52 (1.92%)  2/92 (2.17%) 
Fatigue * 1  3/52 (5.77%)  6/92 (6.52%) 
Fever * 1  0/52 (0.00%)  2/92 (2.17%) 
Gait disturbance * 1  1/52 (1.92%)  0/92 (0.00%) 
Non-cardiac chest pain * 1  0/52 (0.00%)  1/92 (1.09%) 
Infections and infestations     
Abdominal infection * 1  0/52 (0.00%)  1/92 (1.09%) 
Bladder infection * 1  0/52 (0.00%)  1/92 (1.09%) 
Encephalomyelitis infection * 1  0/52 (0.00%)  1/92 (1.09%) 
Infections and infestations - Other * 1  0/52 (0.00%)  1/92 (1.09%) 
Lung infection * 1  2/52 (3.85%)  1/92 (1.09%) 
Mucosal infection * 1  0/52 (0.00%)  1/92 (1.09%) 
Sepsis * 1  1/52 (1.92%)  2/92 (2.17%) 
Soft tissue infection * 1  0/52 (0.00%)  1/92 (1.09%) 
Tooth infection * 1  1/52 (1.92%)  0/92 (0.00%) 
Urinary tract infection * 1  3/52 (5.77%)  0/92 (0.00%) 
Wound infection * 1  1/52 (1.92%)  0/92 (0.00%) 
Injury, poisoning and procedural complications     
Dermatitis radiation * 1  1/52 (1.92%)  0/92 (0.00%) 
Fall * 1  1/52 (1.92%)  0/92 (0.00%) 
Postoperative hemorrhage * 1  0/52 (0.00%)  1/92 (1.09%) 
Investigations     
Alanine aminotransferase increased * 1  0/52 (0.00%)  2/92 (2.17%) 
Aspartate aminotransferase increased * 1  0/52 (0.00%)  1/92 (1.09%) 
Creatinine increased * 1  0/52 (0.00%)  1/92 (1.09%) 
Lymphocyte count decreased * 1  2/52 (3.85%)  5/92 (5.43%) 
Neutrophil count decreased * 1  2/52 (3.85%)  8/92 (8.70%) 
Platelet count decreased * 1  3/52 (5.77%)  17/92 (18.48%) 
Weight loss * 1  0/52 (0.00%)  1/92 (1.09%) 
White blood cell decreased * 1  1/52 (1.92%)  9/92 (9.78%) 
Metabolism and nutrition disorders     
Anorexia * 1  0/52 (0.00%)  1/92 (1.09%) 
Dehydration * 1  2/52 (3.85%)  6/92 (6.52%) 
Hyperglycemia * 1  3/52 (5.77%)  3/92 (3.26%) 
Hypoalbuminemia * 1  1/52 (1.92%)  0/92 (0.00%) 
Hypokalemia * 1  1/52 (1.92%)  1/92 (1.09%) 
Hyponatremia * 1  0/52 (0.00%)  5/92 (5.43%) 
Hypophosphatemia * 1  0/52 (0.00%)  1/92 (1.09%) 
Musculoskeletal and connective tissue disorders     
Generalized muscle weakness * 1  3/52 (5.77%)  6/92 (6.52%) 
Muscle weakness left-sided * 1  0/52 (0.00%)  1/92 (1.09%) 
Pain in extremity * 1  0/52 (0.00%)  1/92 (1.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other * 1  1/52 (1.92%)  2/92 (2.17%) 
Nervous system disorders     
Ataxia * 1  1/52 (1.92%)  1/92 (1.09%) 
Central nervous system necrosis * 1  0/52 (0.00%)  1/92 (1.09%) 
Cognitive disturbance * 1  0/52 (0.00%)  2/92 (2.17%) 
Concentration impairment * 1  0/52 (0.00%)  1/92 (1.09%) 
Depressed level of consciousness * 1  0/52 (0.00%)  1/92 (1.09%) 
Dizziness * 1  1/52 (1.92%)  1/92 (1.09%) 
Dysarthria * 1  0/52 (0.00%)  1/92 (1.09%) 
Dysphasia * 1  1/52 (1.92%)  1/92 (1.09%) 
Encephalopathy * 1  0/52 (0.00%)  1/92 (1.09%) 
Headache * 1  1/52 (1.92%)  3/92 (3.26%) 
Hydrocephalus * 1  0/52 (0.00%)  1/92 (1.09%) 
Intracranial hemorrhage * 1  0/52 (0.00%)  2/92 (2.17%) 
Lethargy * 1  0/52 (0.00%)  1/92 (1.09%) 
Memory impairment * 1  0/52 (0.00%)  1/92 (1.09%) 
Nervous system disorders - Other * 1  1/52 (1.92%)  3/92 (3.26%) 
Peripheral motor neuropathy * 1  1/52 (1.92%)  0/92 (0.00%) 
Seizure * 1  5/52 (9.62%)  8/92 (8.70%) 
Somnolence * 1  1/52 (1.92%)  1/92 (1.09%) 
Stroke * 1  0/52 (0.00%)  2/92 (2.17%) 
Psychiatric disorders     
Agitation * 1  1/52 (1.92%)  0/92 (0.00%) 
Confusion * 1  1/52 (1.92%)  2/92 (2.17%) 
Hallucinations * 1  0/52 (0.00%)  1/92 (1.09%) 
Renal and urinary disorders     
Acute kidney injury * 1  0/52 (0.00%)  1/92 (1.09%) 
Hematuria * 1  0/52 (0.00%)  1/92 (1.09%) 
Renal and urinary disorders - Other * 1  1/52 (1.92%)  0/92 (0.00%) 
Urinary incontinence * 1  2/52 (3.85%)  0/92 (0.00%) 
Urinary retention * 1  0/52 (0.00%)  1/92 (1.09%) 
Urinary tract pain * 1  1/52 (1.92%)  0/92 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  1/52 (1.92%)  3/92 (3.26%) 
Hypoxia * 1  1/52 (1.92%)  1/92 (1.09%) 
Pleural effusion * 1  1/52 (1.92%)  0/92 (0.00%) 
Respiratory failure * 1  1/52 (1.92%)  0/92 (0.00%) 
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysesthesia syndrome * 1  0/52 (0.00%)  1/92 (1.09%) 
Pruritus * 1  0/52 (0.00%)  1/92 (1.09%) 
Rash acneiform * 1  1/52 (1.92%)  0/92 (0.00%) 
Rash maculo-papular * 1  0/52 (0.00%)  1/92 (1.09%) 
Surgical and medical procedures     
Surgical and medical procedures - Other * 1  0/52 (0.00%)  1/92 (1.09%) 
Vascular disorders     
Hypertension * 1  0/52 (0.00%)  2/92 (2.17%) 
Hypotension * 1  1/52 (1.92%)  2/92 (2.17%) 
Thromboembolic event * 1  5/52 (9.62%)  5/92 (5.43%) 
Vascular disorders - Other * 1  0/52 (0.00%)  1/92 (1.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo, TMZ, and RT Cediranib, TMZ, and RT
Affected / at Risk (%) Affected / at Risk (%)
Total   49/52 (94.23%)   88/92 (95.65%) 
Blood and lymphatic system disorders     
Anemia * 1  20/52 (38.46%)  27/92 (29.35%) 
Blood and lymphatic system disorders - Other * 1  5/52 (9.62%)  4/92 (4.35%) 
Ear and labyrinth disorders     
Ear pain * 1  3/52 (5.77%)  2/92 (2.17%) 
Hearing impaired * 1  3/52 (5.77%)  2/92 (2.17%) 
Tinnitus * 1  3/52 (5.77%)  6/92 (6.52%) 
Endocrine disorders     
Hypothyroidism * 1  0/52 (0.00%)  6/92 (6.52%) 
Eye disorders     
Blurred vision * 1  3/52 (5.77%)  13/92 (14.13%) 
Eye disorders - Other * 1  1/52 (1.92%)  5/92 (5.43%) 
Gastrointestinal disorders     
Abdominal pain * 1  2/52 (3.85%)  18/92 (19.57%) 
Constipation * 1  24/52 (46.15%)  41/92 (44.57%) 
Diarrhea * 1  8/52 (15.38%)  53/92 (57.61%) 
Dry mouth * 1  1/52 (1.92%)  6/92 (6.52%) 
Dyspepsia * 1  4/52 (7.69%)  7/92 (7.61%) 
Dysphagia * 1  1/52 (1.92%)  7/92 (7.61%) 
Gastroesophageal reflux disease * 1  1/52 (1.92%)  6/92 (6.52%) 
Mucositis oral * 1  0/52 (0.00%)  6/92 (6.52%) 
Nausea * 1  20/52 (38.46%)  59/92 (64.13%) 
Vomiting * 1  4/52 (7.69%)  30/92 (32.61%) 
General disorders     
Chills * 1  1/52 (1.92%)  6/92 (6.52%) 
Edema face * 1  6/52 (11.54%)  3/92 (3.26%) 
Edema limbs * 1  5/52 (9.62%)  7/92 (7.61%) 
Fatigue * 1  41/52 (78.85%)  77/92 (83.70%) 
Fever * 1  3/52 (5.77%)  7/92 (7.61%) 
Gait disturbance * 1  8/52 (15.38%)  8/92 (8.70%) 
Malaise * 1  0/52 (0.00%)  5/92 (5.43%) 
Pain * 1  3/52 (5.77%)  6/92 (6.52%) 
Infections and infestations     
Mucosal infection * 1  4/52 (7.69%)  9/92 (9.78%) 
Urinary tract infection * 1  5/52 (9.62%)  6/92 (6.52%) 
Injury, poisoning and procedural complications     
Bruising * 1  0/52 (0.00%)  7/92 (7.61%) 
Dermatitis radiation * 1  10/52 (19.23%)  15/92 (16.30%) 
Fall * 1  3/52 (5.77%)  5/92 (5.43%) 
Investigations     
Alanine aminotransferase increased * 1  14/52 (26.92%)  41/92 (44.57%) 
Alkaline phosphatase increased * 1  2/52 (3.85%)  8/92 (8.70%) 
Aspartate aminotransferase increased * 1  6/52 (11.54%)  25/92 (27.17%) 
Blood bilirubin increased * 1  3/52 (5.77%)  10/92 (10.87%) 
CD4 lymphocytes decreased * 1  3/52 (5.77%)  3/92 (3.26%) 
Creatinine increased * 1  5/52 (9.62%)  16/92 (17.39%) 
Hemoglobin increased * 1  1/52 (1.92%)  6/92 (6.52%) 
Investigations - Other * 1  10/52 (19.23%)  21/92 (22.83%) 
Lymphocyte count decreased * 1  17/52 (32.69%)  35/92 (38.04%) 
Neutrophil count decreased * 1  7/52 (13.46%)  25/92 (27.17%) 
Platelet count decreased * 1  19/52 (36.54%)  54/92 (58.70%) 
Weight loss * 1  6/52 (11.54%)  24/92 (26.09%) 
White blood cell decreased * 1  14/52 (26.92%)  40/92 (43.48%) 
Metabolism and nutrition disorders     
Anorexia * 1  22/52 (42.31%)  42/92 (45.65%) 
Dehydration * 1  2/52 (3.85%)  13/92 (14.13%) 
Hypercalcemia * 1  1/52 (1.92%)  6/92 (6.52%) 
Hyperglycemia * 1  19/52 (36.54%)  35/92 (38.04%) 
Hyperkalemia * 1  2/52 (3.85%)  11/92 (11.96%) 
Hypermagnesemia * 1  3/52 (5.77%)  8/92 (8.70%) 
Hypernatremia * 1  6/52 (11.54%)  5/92 (5.43%) 
Hypoalbuminemia * 1  8/52 (15.38%)  15/92 (16.30%) 
Hypocalcemia * 1  7/52 (13.46%)  21/92 (22.83%) 
Hypoglycemia * 1  5/52 (9.62%)  6/92 (6.52%) 
Hypokalemia * 1  12/52 (23.08%)  18/92 (19.57%) 
Hypomagnesemia * 1  4/52 (7.69%)  8/92 (8.70%) 
Hyponatremia * 1  11/52 (21.15%)  27/92 (29.35%) 
Hypophosphatemia * 1  4/52 (7.69%)  8/92 (8.70%) 
Metabolism and nutrition disorders - Other * 1  7/52 (13.46%)  15/92 (16.30%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/52 (3.85%)  6/92 (6.52%) 
Generalized muscle weakness * 1  8/52 (15.38%)  23/92 (25.00%) 
Muscle weakness left-sided * 1  3/52 (5.77%)  3/92 (3.26%) 
Musculoskeletal and connective tissue disorder - Other * 1  3/52 (5.77%)  7/92 (7.61%) 
Myalgia * 1  4/52 (7.69%)  8/92 (8.70%) 
Pain in extremity * 1  3/52 (5.77%)  10/92 (10.87%) 
Nervous system disorders     
Amnesia * 1  4/52 (7.69%)  2/92 (2.17%) 
Ataxia * 1  7/52 (13.46%)  15/92 (16.30%) 
Cognitive disturbance * 1  4/52 (7.69%)  7/92 (7.61%) 
Dizziness * 1  14/52 (26.92%)  25/92 (27.17%) 
Dysarthria * 1  1/52 (1.92%)  5/92 (5.43%) 
Dysgeusia * 1  12/52 (23.08%)  20/92 (21.74%) 
Dysphasia * 1  4/52 (7.69%)  14/92 (15.22%) 
Facial muscle weakness * 1  3/52 (5.77%)  1/92 (1.09%) 
Headache * 1  27/52 (51.92%)  48/92 (52.17%) 
Memory impairment * 1  13/52 (25.00%)  13/92 (14.13%) 
Nervous system disorders - Other * 1  2/52 (3.85%)  11/92 (11.96%) 
Paresthesia * 1  3/52 (5.77%)  4/92 (4.35%) 
Peripheral motor neuropathy * 1  5/52 (9.62%)  2/92 (2.17%) 
Peripheral sensory neuropathy * 1  3/52 (5.77%)  9/92 (9.78%) 
Seizure * 1  4/52 (7.69%)  15/92 (16.30%) 
Somnolence * 1  3/52 (5.77%)  4/92 (4.35%) 
Tremor * 1  4/52 (7.69%)  4/92 (4.35%) 
Psychiatric disorders     
Agitation * 1  3/52 (5.77%)  5/92 (5.43%) 
Anxiety * 1  8/52 (15.38%)  15/92 (16.30%) 
Confusion * 1  6/52 (11.54%)  9/92 (9.78%) 
Depression * 1  3/52 (5.77%)  14/92 (15.22%) 
Insomnia * 1  11/52 (21.15%)  20/92 (21.74%) 
Personality change * 1  3/52 (5.77%)  2/92 (2.17%) 
Renal and urinary disorders     
Urinary frequency * 1  1/52 (1.92%)  8/92 (8.70%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  5/52 (9.62%)  7/92 (7.61%) 
Dyspnea * 1  3/52 (5.77%)  15/92 (16.30%) 
Epistaxis * 1  2/52 (3.85%)  6/92 (6.52%) 
Hoarseness * 1  0/52 (0.00%)  6/92 (6.52%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  27/52 (51.92%)  47/92 (51.09%) 
Dry skin * 1  6/52 (11.54%)  12/92 (13.04%) 
Erythema multiforme * 1  3/52 (5.77%)  3/92 (3.26%) 
Pruritus * 1  4/52 (7.69%)  10/92 (10.87%) 
Rash acneiform * 1  4/52 (7.69%)  4/92 (4.35%) 
Rash maculo-papular * 1  4/52 (7.69%)  6/92 (6.52%) 
Skin and subcutaneous tissue disorders - Other * 1  6/52 (11.54%)  12/92 (13.04%) 
Skin hyperpigmentation * 1  3/52 (5.77%)  5/92 (5.43%) 
Vascular disorders     
Hypertension * 1  8/52 (15.38%)  32/92 (34.78%) 
Hypotension * 1  3/52 (5.77%)  5/92 (5.43%) 
Thromboembolic event * 1  4/52 (7.69%)  6/92 (6.52%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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, M.S.
Organization: NRG Oncology
EMail: seiferheldw@nrgoncology.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01062425    
Other Study ID Numbers: NCI-2011-02012
NCI-2011-02012 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000665163
RTOG-0837
RTOG 0837 ( Other Identifier: NRG Oncology )
RTOG-0837 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA021661 ( U.S. NIH Grant/Contract )
First Submitted: February 3, 2010
First Posted: February 4, 2010
Results First Submitted: July 28, 2016
Results First Posted: September 19, 2016
Last Update Posted: January 2, 2020