Trial Outcomes & Findings for Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme (NCT NCT00482677)
NCT ID: NCT00482677
Last Updated: 2023-08-22
Results Overview
Time from date of randomization to the date of death of any causes, or censored at last known alive date.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
562 participants
Primary outcome timeframe
7 years
Results posted on
2023-08-22
Participant Flow
Participant milestones
| Measure |
Temozolomide
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
|
Radiation
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 Study
STARTED
|
281
|
281
|
|
Overall Study
COMPLETED
|
281
|
281
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
Temozolomide
n=281 Participants
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
|
Radiation
n=281 Participants
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
n=562 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73 years
n=5 Participants
|
73 years
n=7 Participants
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
343 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
101 participants
n=5 Participants
|
98 participants
n=7 Participants
|
199 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
48 participants
n=5 Participants
|
49 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
124 participants
n=5 Participants
|
125 participants
n=7 Participants
|
249 participants
n=5 Participants
|
|
ECOG Performance Status
0, 1
|
215 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
432 Participants
n=5 Participants
|
|
ECOG Performance Status
2
|
66 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Resection
Biopsy only
|
84 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Resection
Complete/incomplete resection
|
197 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
396 Participants
n=5 Participants
|
|
Mini Mental Status Examination
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 yearsTime from date of randomization to the date of death of any causes, or censored at last known alive date.
Outcome measures
| Measure |
Temozolomide
n=281 Participants
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
|
Radiation
n=281 Participants
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 Survival
|
9.33 Months
Interval 8.31 to 10.25
|
7.62 Months
Interval 6.97 to 8.38
|
SECONDARY outcome
Timeframe: 7 yearsTime from date of randomization to the date of disease progression or death whichever came first, or censored at last disease assessment date.
Outcome measures
| Measure |
Temozolomide
n=281 Participants
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
|
Radiation
n=281 Participants
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
|
|---|---|---|
|
Progression-free Survival
|
5.29 Months
Interval 4.6 to 6.21
|
3.94 Months
Interval 3.52 to 4.34
|
SECONDARY outcome
Timeframe: 7 yearsEvaluated according to CTCAE V3.0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 yearsPopulation: Patients with MGMT promoter methylated.
Overall survival for patients by Methylation status of the O6-methylguanine-DNA methyltransferase promoter
Outcome measures
| Measure |
Temozolomide
n=88 Participants
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
|
Radiation
n=77 Participants
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
|
|---|---|---|
|
Methylation Status of the O6-methylguanine-DNA Methyltransferase Promoter
|
13.47 Months
Interval 10.25 to 15.31
|
7.69 Months
Interval 5.82 to 10.68
|
Adverse Events
Temozolomide
Serious events: 158 serious events
Other events: 260 other events
Deaths: 0 deaths
Radiation
Serious events: 135 serious events
Other events: 256 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temozolomide
n=271 participants at risk
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
|
Radiation
n=271 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.8%
5/271
|
0.37%
1/271
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/271
|
0.37%
1/271
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.37%
1/271
|
0.74%
2/271
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.74%
2/271
|
0.00%
0/271
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.37%
1/271
|
0.00%
0/271
|
|
Cardiac disorders
Pain Cardiac/heart
|
0.37%
1/271
|
0.00%
0/271
|
|
Cardiac disorders
Supraventricular arrhythmia Atrial fibrillation
|
0.74%
2/271
|
0.37%
1/271
|
|
Cardiac disorders
Ventricular arrhythmia Ventricular tachycardia
|
0.37%
1/271
|
0.00%
0/271
|
|
Eye disorders
Blurred vision
|
0.74%
2/271
|
0.37%
1/271
|
|
Eye disorders
Glaucoma
|
0.37%
1/271
|
0.00%
0/271
|
|
Eye disorders
Neuropathy: cranial CN II
|
0.74%
2/271
|
1.1%
3/271
|
|
Eye disorders
Pain Eye
|
0.00%
0/271
|
0.37%
1/271
|
|
Gastrointestinal disorders
Constipation
|
0.74%
2/271
|
0.74%
2/271
|
|
Gastrointestinal disorders
Diarrhea
|
0.37%
1/271
|
0.00%
0/271
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
7/271
|
1.8%
5/271
|
|
Gastrointestinal disorders
Hemorrhage, GI Lower GI NOS
|
0.37%
1/271
|
0.00%
0/271
|
|
Gastrointestinal disorders
Hemorrhage, GI Rectum
|
0.00%
0/271
|
0.37%
1/271
|
|
Gastrointestinal disorders
Ileus
|
0.37%
1/271
|
0.00%
0/271
|
|
Gastrointestinal disorders
Incontinence, anal
|
0.00%
0/271
|
0.74%
2/271
|
|
Gastrointestinal disorders
Nausea
|
0.74%
2/271
|
0.37%
1/271
|
|
Gastrointestinal disorders
Pain Abdomen NOS
|
0.74%
2/271
|
0.37%
1/271
|
|
Gastrointestinal disorders
Pancreatitis
|
0.74%
2/271
|
0.00%
0/271
|
|
Gastrointestinal disorders
Perforation, GI Colon
|
0.74%
2/271
|
0.37%
1/271
|
|
Gastrointestinal disorders
Perforation, GI Esophagus
|
0.37%
1/271
|
0.00%
0/271
|
|
Gastrointestinal disorders
Ulcer, GI Stomach
|
0.00%
0/271
|
0.37%
1/271
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
4/271
|
0.74%
2/271
|
|
General disorders
Constitutional Symptoms - Other
|
0.37%
1/271
|
0.37%
1/271
|
|
General disorders
Death Death NOS
|
2.6%
7/271
|
2.6%
7/271
|
|
General disorders
Death Disease progression NOS
|
0.37%
1/271
|
1.1%
3/271
|
|
General disorders
Edema: head and neck
|
0.37%
1/271
|
1.1%
3/271
|
|
General disorders
Edema: limb
|
0.37%
1/271
|
0.37%
1/271
|
|
General disorders
Fatigue
|
6.3%
17/271
|
5.9%
16/271
|
|
General disorders
Fever
|
1.8%
5/271
|
1.1%
3/271
|
|
General disorders
Gait/walking
|
0.37%
1/271
|
0.37%
1/271
|
|
General disorders
Pain Pain NOS
|
0.00%
0/271
|
0.37%
1/271
|
|
General disorders
Syndromes - Other
|
0.37%
1/271
|
0.00%
0/271
|
|
Hepatobiliary disorders
Cholecystitis
|
0.37%
1/271
|
0.00%
0/271
|
|
Infections and infestations
Infection (documented clinically) Colon
|
0.37%
1/271
|
0.00%
0/271
|
|
Infections and infestations
Infection (documented clinically) Lung
|
0.74%
2/271
|
1.5%
4/271
|
|
Infections and infestations
Infection (documented clinically) Muscle
|
0.37%
1/271
|
0.00%
0/271
|
|
Infections and infestations
Infection (documented clinically) Peritoneal cavity
|
0.37%
1/271
|
0.00%
0/271
|
|
Infections and infestations
Infection - Other
|
0.74%
2/271
|
0.74%
2/271
|
|
Infections and infestations
Infection with normal ANC Abdomen NOS
|
0.37%
1/271
|
0.00%
0/271
|
|
Infections and infestations
Infection with normal ANC Bladder
|
0.00%
0/271
|
0.37%
1/271
|
|
Infections and infestations
Infection with normal ANC Blood
|
1.5%
4/271
|
0.00%
0/271
|
|
Infections and infestations
Infection with normal ANC Brain
|
0.37%
1/271
|
0.00%
0/271
|
|
Infections and infestations
Infection with normal ANC Colon
|
0.37%
1/271
|
0.00%
0/271
|
|
Infections and infestations
Infection with normal ANC Lung
|
2.2%
6/271
|
0.74%
2/271
|
|
Infections and infestations
Infection with normal ANC Peritoneal cavity
|
0.37%
1/271
|
0.00%
0/271
|
|
Infections and infestations
Infection with normal ANC Skin
|
0.00%
0/271
|
0.37%
1/271
|
|
Infections and infestations
Infection with normal ANC Soft tissue NOS
|
0.00%
0/271
|
0.37%
1/271
|
|
Infections and infestations
Infection with normal ANC Upper airway NOS
|
0.00%
0/271
|
0.37%
1/271
|
|
Infections and infestations
Infection with normal ANC Urinary tract NOS
|
0.37%
1/271
|
0.37%
1/271
|
|
Infections and infestations
Infection with normal ANC Wound
|
0.37%
1/271
|
0.37%
1/271
|
|
Infections and infestations
Infection with unknown ANC Blood
|
0.37%
1/271
|
0.00%
0/271
|
|
Infections and infestations
Infection with unknown ANC Bronchus
|
0.37%
1/271
|
0.00%
0/271
|
|
Infections and infestations
Infection with unknown ANC Lung
|
0.37%
1/271
|
1.1%
3/271
|
|
Infections and infestations
Infection with unknown ANC Skin
|
0.00%
0/271
|
0.37%
1/271
|
|
Infections and infestations
Infection with unknown ANC Urinary tract NOS
|
0.37%
1/271
|
0.00%
0/271
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
0.00%
0/271
|
0.37%
1/271
|
|
Injury, poisoning and procedural complications
Fracture
|
2.2%
6/271
|
2.6%
7/271
|
|
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access)
|
1.1%
3/271
|
0.74%
2/271
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
0.37%
1/271
|
0.00%
0/271
|
|
Investigations
ADH
|
0.00%
0/271
|
0.37%
1/271
|
|
Investigations
GGT
|
0.37%
1/271
|
0.00%
0/271
|
|
Investigations
Platelets
|
1.5%
4/271
|
0.74%
2/271
|
|
Investigations
Weight loss
|
0.00%
0/271
|
0.37%
1/271
|
|
Metabolism and nutrition disorders
Acidosis
|
0.37%
1/271
|
0.00%
0/271
|
|
Metabolism and nutrition disorders
Anorexia
|
1.5%
4/271
|
1.1%
3/271
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
3/271
|
0.74%
2/271
|
|
Metabolism and nutrition disorders
Diabetes
|
0.74%
2/271
|
0.37%
1/271
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.74%
2/271
|
0.74%
2/271
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/271
|
0.37%
1/271
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/271
|
0.37%
1/271
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
0.37%
1/271
|
0.00%
0/271
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Extremity-lower
|
3.0%
8/271
|
0.74%
2/271
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Extremity-upper
|
0.74%
2/271
|
0.37%
1/271
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Left-sided
|
1.1%
3/271
|
1.5%
4/271
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Right-sided
|
1.1%
3/271
|
0.74%
2/271
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Whole body/generalized
|
1.8%
5/271
|
1.8%
5/271
|
|
Musculoskeletal and connective tissue disorders
Pain Back
|
1.1%
3/271
|
0.37%
1/271
|
|
Musculoskeletal and connective tissue disorders
Pain Bone
|
0.00%
0/271
|
0.74%
2/271
|
|
Musculoskeletal and connective tissue disorders
Pain Extremity-limb
|
0.37%
1/271
|
0.00%
0/271
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain Tumor pain
|
0.00%
0/271
|
0.37%
1/271
|
|
Nervous system disorders
Arachnoiditis
|
0.37%
1/271
|
0.00%
0/271
|
|
Nervous system disorders
Ataxia
|
2.2%
6/271
|
2.2%
6/271
|
|
Nervous system disorders
CNS hemorrhage
|
0.74%
2/271
|
0.74%
2/271
|
|
Nervous system disorders
CNS ischemia
|
1.8%
5/271
|
0.74%
2/271
|
|
Nervous system disorders
CNS necrosis
|
0.00%
0/271
|
0.37%
1/271
|
|
Nervous system disorders
CSF leak
|
0.37%
1/271
|
0.00%
0/271
|
|
Nervous system disorders
Cognitive disturbance
|
5.9%
16/271
|
4.1%
11/271
|
|
Nervous system disorders
Dizziness
|
0.37%
1/271
|
0.37%
1/271
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/271
|
0.37%
1/271
|
|
Nervous system disorders
Hydrocephalus
|
1.1%
3/271
|
0.00%
0/271
|
|
Nervous system disorders
Involuntary movement
|
0.00%
0/271
|
0.37%
1/271
|
|
Nervous system disorders
Memory impairment
|
0.37%
1/271
|
1.1%
3/271
|
|
Nervous system disorders
Neurology - Other
|
0.74%
2/271
|
1.1%
3/271
|
|
Nervous system disorders
Neuropathy-motor
|
10.7%
29/271
|
8.1%
22/271
|
|
Nervous system disorders
Neuropathy-sensory
|
0.37%
1/271
|
1.1%
3/271
|
|
Nervous system disorders
Neuropathy: cranial CN III
|
0.37%
1/271
|
0.00%
0/271
|
|
Nervous system disorders
Neuropathy: cranial CN VII
|
0.37%
1/271
|
0.00%
0/271
|
|
Nervous system disorders
Neuropathy: cranial CN VIII
|
0.00%
0/271
|
0.37%
1/271
|
|
Nervous system disorders
Pain Head/headache
|
1.8%
5/271
|
2.6%
7/271
|
|
Nervous system disorders
Pyramidal tract dysfunction
|
0.37%
1/271
|
0.37%
1/271
|
|
Nervous system disorders
Seizure
|
10.0%
27/271
|
7.4%
20/271
|
|
Nervous system disorders
Somnolence
|
4.1%
11/271
|
7.4%
20/271
|
|
Nervous system disorders
Speech impairment
|
5.9%
16/271
|
7.7%
21/271
|
|
Nervous system disorders
Syncope
|
0.37%
1/271
|
1.1%
3/271
|
|
Psychiatric disorders
Confusion
|
6.3%
17/271
|
8.5%
23/271
|
|
Psychiatric disorders
Mood alteration Agitation
|
2.6%
7/271
|
1.1%
3/271
|
|
Psychiatric disorders
Mood alteration Anxiety
|
0.37%
1/271
|
0.37%
1/271
|
|
Psychiatric disorders
Mood alteration Depression
|
1.5%
4/271
|
0.37%
1/271
|
|
Psychiatric disorders
Personality
|
0.00%
0/271
|
0.74%
2/271
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/271
|
0.37%
1/271
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/271
|
0.37%
1/271
|
|
Renal and urinary disorders
Hemorrhage, GU Kidney
|
0.37%
1/271
|
0.00%
0/271
|
|
Renal and urinary disorders
Incontinence, urinary
|
0.00%
0/271
|
0.74%
2/271
|
|
Renal and urinary disorders
Renal failure
|
0.37%
1/271
|
0.37%
1/271
|
|
Renal and urinary disorders
Urinary retention
|
0.37%
1/271
|
0.00%
0/271
|
|
Reproductive system and breast disorders
Hemorrhage, GU Prostate
|
0.00%
0/271
|
0.37%
1/271
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.74%
2/271
|
1.1%
3/271
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.37%
1/271
|
0.00%
0/271
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.74%
2/271
|
2.2%
6/271
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary Nose
|
0.74%
2/271
|
0.00%
0/271
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.37%
1/271
|
0.00%
0/271
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.37%
1/271
|
0.00%
0/271
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
4/271
|
1.8%
5/271
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.37%
1/271
|
0.37%
1/271
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
0.74%
2/271
|
0.37%
1/271
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.37%
1/271
|
0.00%
0/271
|
|
Skin and subcutaneous tissue disorders
Decubitus
|
0.37%
1/271
|
0.00%
0/271
|
|
Skin and subcutaneous tissue disorders
Dermatology - Other
|
0.00%
0/271
|
0.37%
1/271
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/271
|
0.37%
1/271
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.37%
1/271
|
0.00%
0/271
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.37%
1/271
|
0.37%
1/271
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.37%
1/271
|
0.00%
0/271
|
|
Vascular disorders
Hematoma
|
0.00%
0/271
|
0.37%
1/271
|
|
Vascular disorders
Hypertension
|
0.37%
1/271
|
0.00%
0/271
|
|
Vascular disorders
Hypotension
|
0.74%
2/271
|
0.00%
0/271
|
|
Vascular disorders
Phlebitis
|
0.37%
1/271
|
0.00%
0/271
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
9.2%
25/271
|
3.7%
10/271
|
Other adverse events
| Measure |
Temozolomide
n=271 participants at risk
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
|
Radiation
n=271 participants at risk
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
|
|---|---|---|
|
Ear and labyrinth disorders
Hearing (without monitoring program)
|
5.5%
15/271
|
5.2%
14/271
|
|
Eye disorders
Blurred vision
|
5.5%
15/271
|
7.7%
21/271
|
|
Gastrointestinal disorders
Constipation
|
27.3%
74/271
|
10.7%
29/271
|
|
Gastrointestinal disorders
Diarrhea
|
7.0%
19/271
|
1.8%
5/271
|
|
Gastrointestinal disorders
Dysphagia
|
7.4%
20/271
|
6.6%
18/271
|
|
Gastrointestinal disorders
Nausea
|
28.4%
77/271
|
15.5%
42/271
|
|
Gastrointestinal disorders
Vomiting
|
14.0%
38/271
|
5.5%
15/271
|
|
General disorders
Edema: limb
|
18.5%
50/271
|
12.9%
35/271
|
|
General disorders
Fatigue
|
58.3%
158/271
|
54.2%
147/271
|
|
General disorders
Gait/walking
|
8.1%
22/271
|
7.0%
19/271
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
8.1%
22/271
|
8.1%
22/271
|
|
Metabolism and nutrition disorders
Anorexia
|
15.1%
41/271
|
14.0%
38/271
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Extremity-lower
|
15.5%
42/271
|
12.5%
34/271
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Whole body/generalized
|
6.3%
17/271
|
6.6%
18/271
|
|
Musculoskeletal and connective tissue disorders
Pain Muscle
|
5.9%
16/271
|
3.0%
8/271
|
|
Nervous system disorders
Ataxia
|
11.1%
30/271
|
10.7%
29/271
|
|
Nervous system disorders
Cognitive disturbance
|
20.3%
55/271
|
17.0%
46/271
|
|
Nervous system disorders
Dizziness
|
15.9%
43/271
|
9.2%
25/271
|
|
Nervous system disorders
Memory impairment
|
24.4%
66/271
|
23.6%
64/271
|
|
Nervous system disorders
Neurology - Other
|
7.0%
19/271
|
5.9%
16/271
|
|
Nervous system disorders
Neuropathy-motor
|
28.4%
77/271
|
24.0%
65/271
|
|
Nervous system disorders
Neuropathy-sensory
|
8.9%
24/271
|
5.5%
15/271
|
|
Nervous system disorders
Pain Head/headache
|
23.6%
64/271
|
28.8%
78/271
|
|
Nervous system disorders
Seizure
|
26.9%
73/271
|
21.0%
57/271
|
|
Nervous system disorders
Somnolence
|
8.9%
24/271
|
14.4%
39/271
|
|
Nervous system disorders
Speech impairment
|
25.1%
68/271
|
28.4%
77/271
|
|
Nervous system disorders
Tremor
|
6.6%
18/271
|
5.9%
16/271
|
|
Psychiatric disorders
Confusion
|
24.4%
66/271
|
24.0%
65/271
|
|
Psychiatric disorders
Insomnia
|
11.4%
31/271
|
11.4%
31/271
|
|
Psychiatric disorders
Mood alteration Agitation
|
9.6%
26/271
|
5.9%
16/271
|
|
Psychiatric disorders
Mood alteration Anxiety
|
7.0%
19/271
|
4.4%
12/271
|
|
Psychiatric disorders
Mood alteration Depression
|
13.7%
37/271
|
7.4%
20/271
|
|
Renal and urinary disorders
Incontinence, urinary
|
8.1%
22/271
|
6.3%
17/271
|
|
Renal and urinary disorders
Urinary frequency
|
7.0%
19/271
|
5.9%
16/271
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
23/271
|
10.0%
27/271
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
30/271
|
9.2%
25/271
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.5%
69/271
|
28.4%
77/271
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.3%
17/271
|
3.0%
8/271
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.7%
29/271
|
7.0%
19/271
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
12.5%
34/271
|
8.5%
23/271
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place