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Trial record 1 of 1 for:    NCT00482677
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Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme

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: NCT00482677
Recruitment Status : Completed
First Posted : June 5, 2007
Results First Posted : January 23, 2018
Last Update Posted : April 9, 2020
Sponsor:
Collaborators:
European Organisation for Research and Treatment of Cancer - EORTC
Trans-Tasman Radiation Oncology Group (TROG)
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Brain and Central Nervous System Tumors
Interventions Drug: temozolomide
Genetic: DNA methylation analysis
Procedure: quality-of-life assessment
Radiation: Radiation
Enrollment 562
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Temozolomide Radiation
Hide Arm/Group Description

Temozolomide and short course radiation

temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.

DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms

quality-of-life assessment: prior to randomization until end of study

Short course radiation alone

DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms

quality-of-life assessment: prior to randomization until end of study

Radiation: Short course radiotherapy

Period Title: Overall Study
Started 281 281
Completed 281 281
Not Completed 0 0
Arm/Group Title Temozolomide Radiation Total
Hide Arm/Group Description

Temozolomide and short course radiation

temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.

DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms

quality-of-life assessment: prior to randomization until end of study

Short course radiation alone

DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms

quality-of-life assessment: prior to randomization until end of study

Radiation: Short course radiotherapy

Total of all reporting groups
Overall Number of Baseline Participants 281 281 562
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 281 participants 281 participants 562 participants
73
(65 to 90)
73
(65 to 88)
73
(65 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 281 participants 281 participants 562 participants
Female 110 109 219
Male 171 172 343
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 281 participants 281 participants 562 participants
Canada 101 98 199
Netherlands 48 49 97
Japan 8 9 17
Germany 124 125 249
ECOG Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 281 participants 281 participants 562 participants
0, 1
215
  76.5%
217
  77.2%
432
  76.9%
2
66
  23.5%
64
  22.8%
130
  23.1%
[1]
Measure Description: "The ECOG Scale of Performance Status ranges between 0 (Fully active, able to carry on all pre-disease performance without restriction) and 5 (Dead).
Resection  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 281 participants 281 participants 562 participants
Biopsy only
84
  29.9%
82
  29.2%
166
  29.5%
Complete/incomplete resection
197
  70.1%
199
  70.8%
396
  70.5%
Mini Mental Status Examination  
Median (Full Range)
Unit of measure:  Participants
Number Analyzed 281 participants 281 participants 562 participants
27
(5 to 30)
27
(7 to 30)
27
(5 to 30)
1.Primary Outcome
Title Overall Survival
Hide Description Time from date of randomization to the date of death of any causes, or censored at last known alive date.
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Temozolomide Radiation
Hide Arm/Group Description:

Temozolomide and short course radiation

temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.

DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms

quality-of-life assessment: prior to randomization until end of study

Short course radiation alone

DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms

quality-of-life assessment: prior to randomization until end of study

Radiation: Short course radiotherapy

Overall Number of Participants Analyzed 281 281
Median (95% Confidence Interval)
Unit of Measure: Months
9.33
(8.31 to 10.25)
7.62
(6.97 to 8.38)
2.Secondary Outcome
Title Progression-free Survival
Hide Description Time from date of randomization to the date of disease progression or death whichever came first, or censored at last disease assessment date.
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Temozolomide Radiation
Hide Arm/Group Description:

Temozolomide and short course radiation

temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.

DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms

quality-of-life assessment: prior to randomization until end of study

Short course radiation alone

DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms

quality-of-life assessment: prior to randomization until end of study

Radiation: Short course radiotherapy

Overall Number of Participants Analyzed 281 281
Median (95% Confidence Interval)
Unit of Measure: Months
5.29
(4.60 to 6.21)
3.94
(3.52 to 4.34)
3.Secondary Outcome
Title Adverse Events
Hide Description Evaluated according to CTCAE V3.0
Time Frame 7 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Methylation Status of the O6-methylguanine-DNA Methyltransferase Promoter
Hide Description Overall survival for patients by Methylation status of the O6-methylguanine-DNA methyltransferase promoter
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with MGMT promoter methylated.
Arm/Group Title Temozolomide Radiation
Hide Arm/Group Description:

Temozolomide and short course radiation

temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.

DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms

quality-of-life assessment: prior to randomization until end of study

Short course radiation alone

DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms

quality-of-life assessment: prior to randomization until end of study

Radiation: Short course radiotherapy

Overall Number of Participants Analyzed 88 77
Median (95% Confidence Interval)
Unit of Measure: Months
13.47
(10.25 to 15.31)
7.69
(5.82 to 10.68)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Temozolomide Radiation
Hide Arm/Group Description

Temozolomide and short course radiation

temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.

DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms

quality-of-life assessment: prior to randomization until end of study

Short course radiation alone

DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms

quality-of-life assessment: prior to randomization until end of study

Radiation: Short course radiotherapy

All-Cause Mortality
Temozolomide Radiation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Temozolomide Radiation
Affected / at Risk (%) Affected / at Risk (%)
Total   158/271 (58.30%)   135/271 (49.82%) 
Blood and lymphatic system disorders     
Febrile neutropenia   5/271 (1.85%)  1/271 (0.37%) 
Hemoglobin   0/271 (0.00%)  1/271 (0.37%) 
Cardiac disorders     
Cardiac ischemia/infarction   1/271 (0.37%)  2/271 (0.74%) 
Cardiopulmonary arrest   2/271 (0.74%)  0/271 (0.00%) 
Left ventricular systolic dysfunction   1/271 (0.37%)  0/271 (0.00%) 
Pain Cardiac/heart   1/271 (0.37%)  0/271 (0.00%) 
Supraventricular arrhythmia Atrial fibrillation   2/271 (0.74%)  1/271 (0.37%) 
Ventricular arrhythmia Ventricular tachycardia   1/271 (0.37%)  0/271 (0.00%) 
Eye disorders     
Blurred vision   2/271 (0.74%)  1/271 (0.37%) 
Glaucoma   1/271 (0.37%)  0/271 (0.00%) 
Neuropathy: cranial CN II   2/271 (0.74%)  3/271 (1.11%) 
Pain Eye   0/271 (0.00%)  1/271 (0.37%) 
Gastrointestinal disorders     
Constipation   2/271 (0.74%)  2/271 (0.74%) 
Diarrhea   1/271 (0.37%)  0/271 (0.00%) 
Dysphagia   7/271 (2.58%)  5/271 (1.85%) 
Hemorrhage, GI Lower GI NOS   1/271 (0.37%)  0/271 (0.00%) 
Hemorrhage, GI Rectum   0/271 (0.00%)  1/271 (0.37%) 
Ileus   1/271 (0.37%)  0/271 (0.00%) 
Incontinence, anal   0/271 (0.00%)  2/271 (0.74%) 
Nausea   2/271 (0.74%)  1/271 (0.37%) 
Pain Abdomen NOS   2/271 (0.74%)  1/271 (0.37%) 
Pancreatitis   2/271 (0.74%)  0/271 (0.00%) 
Perforation, GI Colon   2/271 (0.74%)  1/271 (0.37%) 
Perforation, GI Esophagus   1/271 (0.37%)  0/271 (0.00%) 
Ulcer, GI Stomach   0/271 (0.00%)  1/271 (0.37%) 
Vomiting   4/271 (1.48%)  2/271 (0.74%) 
General disorders     
Constitutional Symptoms - Other   1/271 (0.37%)  1/271 (0.37%) 
Death Death NOS   7/271 (2.58%)  7/271 (2.58%) 
Death Disease progression NOS   1/271 (0.37%)  3/271 (1.11%) 
Edema: head and neck   1/271 (0.37%)  3/271 (1.11%) 
Edema: limb   1/271 (0.37%)  1/271 (0.37%) 
Fatigue   17/271 (6.27%)  16/271 (5.90%) 
Fever   5/271 (1.85%)  3/271 (1.11%) 
Gait/walking   1/271 (0.37%)  1/271 (0.37%) 
Pain Pain NOS   0/271 (0.00%)  1/271 (0.37%) 
Syndromes - Other   1/271 (0.37%)  0/271 (0.00%) 
Hepatobiliary disorders     
Cholecystitis   1/271 (0.37%)  0/271 (0.00%) 
Infections and infestations     
Infection (documented clinically) Colon   1/271 (0.37%)  0/271 (0.00%) 
Infection (documented clinically) Lung   2/271 (0.74%)  4/271 (1.48%) 
Infection (documented clinically) Muscle   1/271 (0.37%)  0/271 (0.00%) 
Infection (documented clinically) Peritoneal cavity   1/271 (0.37%)  0/271 (0.00%) 
Infection - Other   2/271 (0.74%)  2/271 (0.74%) 
Infection with normal ANC Abdomen NOS   1/271 (0.37%)  0/271 (0.00%) 
Infection with normal ANC Bladder   0/271 (0.00%)  1/271 (0.37%) 
Infection with normal ANC Blood   4/271 (1.48%)  0/271 (0.00%) 
Infection with normal ANC Brain   1/271 (0.37%)  0/271 (0.00%) 
Infection with normal ANC Colon   1/271 (0.37%)  0/271 (0.00%) 
Infection with normal ANC Lung   6/271 (2.21%)  2/271 (0.74%) 
Infection with normal ANC Peritoneal cavity   1/271 (0.37%)  0/271 (0.00%) 
Infection with normal ANC Skin   0/271 (0.00%)  1/271 (0.37%) 
Infection with normal ANC Soft tissue NOS   0/271 (0.00%)  1/271 (0.37%) 
Infection with normal ANC Upper airway NOS   0/271 (0.00%)  1/271 (0.37%) 
Infection with normal ANC Urinary tract NOS   1/271 (0.37%)  1/271 (0.37%) 
Infection with normal ANC Wound   1/271 (0.37%)  1/271 (0.37%) 
Infection with unknown ANC Blood   1/271 (0.37%)  0/271 (0.00%) 
Infection with unknown ANC Bronchus   1/271 (0.37%)  0/271 (0.00%) 
Infection with unknown ANC Lung   1/271 (0.37%)  3/271 (1.11%) 
Infection with unknown ANC Skin   0/271 (0.00%)  1/271 (0.37%) 
Infection with unknown ANC Urinary tract NOS   1/271 (0.37%)  0/271 (0.00%) 
Injury, poisoning and procedural complications     
Dermatitis Radiation   0/271 (0.00%)  1/271 (0.37%) 
Fracture   6/271 (2.21%)  7/271 (2.58%) 
Thrombosis/embolism (vascular access)   3/271 (1.11%)  2/271 (0.74%) 
Wound complication, non-infectious   1/271 (0.37%)  0/271 (0.00%) 
Investigations     
ADH   0/271 (0.00%)  1/271 (0.37%) 
GGT   1/271 (0.37%)  0/271 (0.00%) 
Platelets   4/271 (1.48%)  2/271 (0.74%) 
Weight loss   0/271 (0.00%)  1/271 (0.37%) 
Metabolism and nutrition disorders     
Acidosis   1/271 (0.37%)  0/271 (0.00%) 
Anorexia   4/271 (1.48%)  3/271 (1.11%) 
Dehydration   3/271 (1.11%)  2/271 (0.74%) 
Diabetes   2/271 (0.74%)  1/271 (0.37%) 
Hyperglycemia   2/271 (0.74%)  2/271 (0.74%) 
Hypernatremia   0/271 (0.00%)  1/271 (0.37%) 
Hypokalemia   0/271 (0.00%)  1/271 (0.37%) 
Musculoskeletal and connective tissue disorders     
Joint-function   1/271 (0.37%)  0/271 (0.00%) 
Muscle weakness Extremity-lower   8/271 (2.95%)  2/271 (0.74%) 
Muscle weakness Extremity-upper   2/271 (0.74%)  1/271 (0.37%) 
Muscle weakness Left-sided   3/271 (1.11%)  4/271 (1.48%) 
Muscle weakness Right-sided   3/271 (1.11%)  2/271 (0.74%) 
Muscle weakness Whole body/generalized   5/271 (1.85%)  5/271 (1.85%) 
Pain Back   3/271 (1.11%)  1/271 (0.37%) 
Pain Bone   0/271 (0.00%)  2/271 (0.74%) 
Pain Extremity-limb   1/271 (0.37%)  0/271 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pain Tumor pain   0/271 (0.00%)  1/271 (0.37%) 
Nervous system disorders     
Arachnoiditis   1/271 (0.37%)  0/271 (0.00%) 
Ataxia   6/271 (2.21%)  6/271 (2.21%) 
CNS hemorrhage   2/271 (0.74%)  2/271 (0.74%) 
CNS ischemia   5/271 (1.85%)  2/271 (0.74%) 
CNS necrosis   0/271 (0.00%)  1/271 (0.37%) 
CSF leak   1/271 (0.37%)  0/271 (0.00%) 
Cognitive disturbance   16/271 (5.90%)  11/271 (4.06%) 
Dizziness   1/271 (0.37%)  1/271 (0.37%) 
Encephalopathy   0/271 (0.00%)  1/271 (0.37%) 
Hydrocephalus   3/271 (1.11%)  0/271 (0.00%) 
Involuntary movement   0/271 (0.00%)  1/271 (0.37%) 
Memory impairment   1/271 (0.37%)  3/271 (1.11%) 
Neurology - Other   2/271 (0.74%)  3/271 (1.11%) 
Neuropathy-motor   29/271 (10.70%)  22/271 (8.12%) 
Neuropathy-sensory   1/271 (0.37%)  3/271 (1.11%) 
Neuropathy: cranial CN III   1/271 (0.37%)  0/271 (0.00%) 
Neuropathy: cranial CN VII   1/271 (0.37%)  0/271 (0.00%) 
Neuropathy: cranial CN VIII   0/271 (0.00%)  1/271 (0.37%) 
Pain Head/headache   5/271 (1.85%)  7/271 (2.58%) 
Pyramidal tract dysfunction   1/271 (0.37%)  1/271 (0.37%) 
Seizure   27/271 (9.96%)  20/271 (7.38%) 
Somnolence   11/271 (4.06%)  20/271 (7.38%) 
Speech impairment   16/271 (5.90%)  21/271 (7.75%) 
Syncope   1/271 (0.37%)  3/271 (1.11%) 
Psychiatric disorders     
Confusion   17/271 (6.27%)  23/271 (8.49%) 
Mood alteration Agitation   7/271 (2.58%)  3/271 (1.11%) 
Mood alteration Anxiety   1/271 (0.37%)  1/271 (0.37%) 
Mood alteration Depression   4/271 (1.48%)  1/271 (0.37%) 
Personality   0/271 (0.00%)  2/271 (0.74%) 
Psychosis   0/271 (0.00%)  1/271 (0.37%) 
Renal and urinary disorders     
Cystitis   0/271 (0.00%)  1/271 (0.37%) 
Hemorrhage, GU Kidney   1/271 (0.37%)  0/271 (0.00%) 
Incontinence, urinary   0/271 (0.00%)  2/271 (0.74%) 
Renal failure   1/271 (0.37%)  1/271 (0.37%) 
Urinary retention   1/271 (0.37%)  0/271 (0.00%) 
Reproductive system and breast disorders     
Hemorrhage, GU Prostate   0/271 (0.00%)  1/271 (0.37%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration   2/271 (0.74%)  3/271 (1.11%) 
Cough   1/271 (0.37%)  0/271 (0.00%) 
Dyspnea   2/271 (0.74%)  6/271 (2.21%) 
Hemorrhage pulmonary Nose   2/271 (0.74%)  0/271 (0.00%) 
Hypoxia   1/271 (0.37%)  0/271 (0.00%) 
Pleural effusion   1/271 (0.37%)  0/271 (0.00%) 
Pneumonitis   4/271 (1.48%)  5/271 (1.85%) 
Pneumothorax   1/271 (0.37%)  1/271 (0.37%) 
Pulmonary - Other   2/271 (0.74%)  1/271 (0.37%) 
Pulmonary hypertension   1/271 (0.37%)  0/271 (0.00%) 
Skin and subcutaneous tissue disorders     
Decubitus   1/271 (0.37%)  0/271 (0.00%) 
Dermatology - Other   0/271 (0.00%)  1/271 (0.37%) 
Erythema multiforme   0/271 (0.00%)  1/271 (0.37%) 
Petechiae   1/271 (0.37%)  0/271 (0.00%) 
Rash   1/271 (0.37%)  1/271 (0.37%) 
Ulceration   1/271 (0.37%)  0/271 (0.00%) 
Vascular disorders     
Hematoma   0/271 (0.00%)  1/271 (0.37%) 
Hypertension   1/271 (0.37%)  0/271 (0.00%) 
Hypotension   2/271 (0.74%)  0/271 (0.00%) 
Phlebitis   1/271 (0.37%)  0/271 (0.00%) 
Thrombosis/thrombus/embolism   25/271 (9.23%)  10/271 (3.69%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Temozolomide Radiation
Affected / at Risk (%) Affected / at Risk (%)
Total   260/271 (95.94%)   256/271 (94.46%) 
Ear and labyrinth disorders     
Hearing (without monitoring program)   15/271 (5.54%)  14/271 (5.17%) 
Eye disorders     
Blurred vision   15/271 (5.54%)  21/271 (7.75%) 
Gastrointestinal disorders     
Constipation   74/271 (27.31%)  29/271 (10.70%) 
Diarrhea   19/271 (7.01%)  5/271 (1.85%) 
Dysphagia   20/271 (7.38%)  18/271 (6.64%) 
Nausea   77/271 (28.41%)  42/271 (15.50%) 
Vomiting   38/271 (14.02%)  15/271 (5.54%) 
General disorders     
Edema: limb   50/271 (18.45%)  35/271 (12.92%) 
Fatigue   158/271 (58.30%)  147/271 (54.24%) 
Gait/walking   22/271 (8.12%)  19/271 (7.01%) 
Injury, poisoning and procedural complications     
Dermatitis Radiation   22/271 (8.12%)  22/271 (8.12%) 
Metabolism and nutrition disorders     
Anorexia   41/271 (15.13%)  38/271 (14.02%) 
Musculoskeletal and connective tissue disorders     
Muscle weakness Extremity-lower   42/271 (15.50%)  34/271 (12.55%) 
Muscle weakness Whole body/generalized   17/271 (6.27%)  18/271 (6.64%) 
Pain Muscle   16/271 (5.90%)  8/271 (2.95%) 
Nervous system disorders     
Ataxia   30/271 (11.07%)  29/271 (10.70%) 
Cognitive disturbance   55/271 (20.30%)  46/271 (16.97%) 
Dizziness   43/271 (15.87%)  25/271 (9.23%) 
Memory impairment   66/271 (24.35%)  64/271 (23.62%) 
Neurology - Other   19/271 (7.01%)  16/271 (5.90%) 
Neuropathy-motor   77/271 (28.41%)  65/271 (23.99%) 
Neuropathy-sensory   24/271 (8.86%)  15/271 (5.54%) 
Pain Head/headache   64/271 (23.62%)  78/271 (28.78%) 
Seizure   73/271 (26.94%)  57/271 (21.03%) 
Somnolence   24/271 (8.86%)  39/271 (14.39%) 
Speech impairment   68/271 (25.09%)  77/271 (28.41%) 
Tremor   18/271 (6.64%)  16/271 (5.90%) 
Psychiatric disorders     
Confusion   66/271 (24.35%)  65/271 (23.99%) 
Insomnia   31/271 (11.44%)  31/271 (11.44%) 
Mood alteration Agitation   26/271 (9.59%)  16/271 (5.90%) 
Mood alteration Anxiety   19/271 (7.01%)  12/271 (4.43%) 
Mood alteration Depression   37/271 (13.65%)  20/271 (7.38%) 
Renal and urinary disorders     
Incontinence, urinary   22/271 (8.12%)  17/271 (6.27%) 
Urinary frequency   19/271 (7.01%)  16/271 (5.90%) 
Respiratory, thoracic and mediastinal disorders     
Cough   23/271 (8.49%)  27/271 (9.96%) 
Dyspnea   30/271 (11.07%)  25/271 (9.23%) 
Skin and subcutaneous tissue disorders     
Alopecia   69/271 (25.46%)  77/271 (28.41%) 
Pruritus   17/271 (6.27%)  8/271 (2.95%) 
Rash   29/271 (10.70%)  19/271 (7.01%) 
Vascular disorders     
Thrombosis/thrombus/embolism   34/271 (12.55%)  23/271 (8.49%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Keyue Ding
Organization: Canadian Cancer Trials Group
Phone: 613-5336430
EMail: kding@ctg.queensu.ca
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Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT00482677    
Obsolete Identifiers: NCT00493207
Other Study ID Numbers: CE6
CAN-NCIC-CE6 ( Registry Identifier: NCI US - Physician Data Query )
EORTC-26062-22061 ( Other Identifier: EORTC )
TROG 08.02 ( Other Identifier: Trans-Tasman Radiation Oncology Group )
SPRI-CAN-NCIC-CE.6
CDR0000547163 ( Other Identifier: PDQ )
First Submitted: June 4, 2007
First Posted: June 5, 2007
Results First Submitted: February 14, 2017
Results First Posted: January 23, 2018
Last Update Posted: April 9, 2020