Trial Outcomes & Findings for Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma (NCT NCT00304031)

Last Updated: 2020-06-09

Results Overview

Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Analysis occurred after 647 deaths were reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1173 participants

Primary outcome timeframe

From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.

Results posted on

2020-06-09

Participant Flow

Sites were required to submit participant tumor tissue for central histologic review and MGMT (O-6-methylguanine-DNA methyltransferase) status determination in order for registered participants to continue on the study. Of 1173 participants initially registered, 1125 participants met these requirements and started protocol treatment.

Participant milestones

Participant milestones
Measure	No Adjuvant TMZ (Not Randomized) Concurrent radiation therapy (RT) with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.	Conventional Adjuvant TMZ Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Concomitant RT+TMZ (Pre-randomization) STARTED	1125	0	0
Concomitant RT+TMZ (Pre-randomization) Eligible Pre-randomization Population	1125	0	0
Concomitant RT+TMZ (Pre-randomization) Eligible Pre-randomization Follow-up	1120	0	0
Concomitant RT+TMZ (Pre-randomization) COMPLETED	833	0	0
Concomitant RT+TMZ (Pre-randomization) NOT COMPLETED	292	0	0
Randomization to Adjuvant TMZ Arm STARTED	0	411	422
Randomization to Adjuvant TMZ Arm Eligible Population	0	411	420
Randomization to Adjuvant TMZ Arm Unmethylated MGMT Population	0	254	262
Randomization to Adjuvant TMZ Arm Methylated MGMT Population	0	122	122
Randomization to Adjuvant TMZ Arm Quality of Life Population	0	96	95
Randomization to Adjuvant TMZ Arm COMPLETED	0	411	420
Randomization to Adjuvant TMZ Arm NOT COMPLETED	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	No Adjuvant TMZ (Not Randomized) Concurrent radiation therapy (RT) with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.	Dose-dense Adjuvant TMZ Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Concomitant RT+TMZ (Pre-randomization) Ineligible due to insufficient tissue	144	0
Concomitant RT+TMZ (Pre-randomization) Disease progression	48	0
Concomitant RT+TMZ (Pre-randomization) Patient refusal	19	0
Concomitant RT+TMZ (Pre-randomization) Death	18	0
Concomitant RT+TMZ (Pre-randomization) Physician preference	15	0
Concomitant RT+TMZ (Pre-randomization) Toxicity	10	0
Concomitant RT+TMZ (Pre-randomization) Other complicating disease	1	0
Concomitant RT+TMZ (Pre-randomization) Other, not otherwise specified	37	0
Randomization to Adjuvant TMZ Arm No follow-up collected	0	2

Baseline Characteristics

Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Adjuvant TMZ (Not Randomized ) n=292 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.	Conventional Adjuvant TMZ n=411 Participants Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=422 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.	Total n=1125 Participants Total of all reporting groups
Age, Continuous	60.5 years n=5 Participants	57 years n=7 Participants	58 years n=5 Participants	58 years n=4 Participants
Sex: Female, Male Female	126 Participants n=5 Participants	172 Participants n=7 Participants	185 Participants n=5 Participants	483 Participants n=4 Participants
Sex: Female, Male Male	166 Participants n=5 Participants	239 Participants n=7 Participants	237 Participants n=5 Participants	642 Participants n=4 Participants

PRIMARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.

Population: Randomized eligible patients.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=411 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=420 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Median Overall Survival Time	16.6 months Interval 14.9 to 18.0	14.9 months Interval 13.7 to 16.5

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.

Population: Randomized eligible patients

Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of radiation therapy. Analysis occurred after 647 deaths were reported.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=411 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=420 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Median Progression-free Survival (PFS) Time	5.5 months Interval 4.7 to 6.1	6.7 months Interval 6.2 to 7.7

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.

Population: MGMT status was not available for all randomized eligible participants. Therefore, data was only available from 376/411 on the conventional arm and 384/420 on the dose-dense arm.

Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=376 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=384 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Median Overall Survival Time by MGMT Status Methylated MGMT	21.4 months Interval 17.6 to 29.0	20.2 months Interval 15.4 to 25.1
Median Overall Survival Time by MGMT Status Unmethylated MGMT	14.6 months Interval 13.2 to 16.5	13.3 months Interval 12.3 to 14.3

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.

Population: MGMT status was not available for all randomized eligible participants. Therefore, data was only available from 376/411 on the conventional arm and 384/420 on the dose-dense arm.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=376 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=384 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Median Progression-free Survival Time by MGMT Status Unmethylated MGMT	5.1 months Interval 4.3 to 5.7	6.0 months Interval 5.5 to 6.5
Median Progression-free Survival Time by MGMT Status Methylated MGMT	6.5 months Interval 4.1 to 9.6	10.1 months Interval 7.9 to 12.4

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.

Population: Per the protocol, both arms are combined to compare between MGMT status. MGMT status and treatment response was not available for all randomized eligible participants. Therefore, data was only available for 748/831 randomized eligible patients (arms combined).

Response assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.0): Complete Response (CR), imaging no longer shows enhancing tumor, confirmed by a second scan ≥ 4 weeks later; Partial Response (PR), \>=50% decrease in tumor area (two diameters) with patient off all steroids, or on adrenal maintenance only; Minor Response (MR), \< 50% decrease in tumor area with patient off all steroids, or on adrenal maintenance only; Stable Disease (SD): scan shows no change with patient receiving stable/decreasing doses of steroids; Progression (P): \> 25% increase in tumor area with no decrease in steroid dose since last evaluation. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=240 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=508 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Best Treatment Response by MGMT Status Complete Response	47 Participants	67 Participants
Best Treatment Response by MGMT Status Partial Response	34 Participants	66 Participants
Best Treatment Response by MGMT Status Minor Response	31 Participants	55 Participants
Best Treatment Response by MGMT Status Stable Response	110 Participants	243 Participants
Best Treatment Response by MGMT Status Progressive Disease	18 Participants	77 Participants

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.

Population: Randomized eligible patients with any adverse events reported as possibly/probably/definitely related to protocol treatment

Highest grade adverse event (AE) per subject was counted. 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. Analysis occurred after 647 deaths were reported.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=351 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=369 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Distribution of Highest Grade AE Reported as Possibly/Probably/Definitely Related to Protocol Treatment Grade 0,1,2	231 Participants	175 Participants
Distribution of Highest Grade AE Reported as Possibly/Probably/Definitely Related to Protocol Treatment Grade 3,4,5	120 Participants	194 Participants

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.

Population: Per the protocol, both arms are combined to compare between 6-month progression status. Eligible pre-randomization participants with any follow-up data.

Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=676 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=444 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Overall Survival Status by Progression Status at 6 Months	20.7 months Interval 19.5 to 22.2	10.1 months Interval 8.8 to 10.9

SECONDARY outcome

Timeframe: Baseline and cycle 10 (approximately 46 weeks)

Population: Cycle 10 questionnaires were not completed by all quality of life (QOL) population participants progression-free at 6 months. Therefore, only 24/96 on the conventional arm and 20/95 on the dose-dense arm had data.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=24 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=20 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy	1.17 score on a scale Interval 0.72 to 1.61	1.18 score on a scale Interval 0.68 to 1.69

SECONDARY outcome

Timeframe: Baseline and cycle 10 (approximately 46 weeks)

Population: Cycle 10 questionnaires were not completed by all QOL population participants progression-free at 6 months. Therefore, only 17/96 on the conventional arm and 20/95 on the dose-dense arm had data.

The NCF Composite score is the arithmetic mean of the Hopkins Verbal Learning Test - Revised (HVLT-R) (Free Recall, Delayed Recall, Delayed Recognition), Trail Making Test Part A (TMTA), Trail Making Test Part B (TMTB), and Controlled Oral Word Association (COWA) test scores, all of which are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. A participant must have at least 5 of the 6 scores. A higher composite score indicates better neurocognitive function.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=17 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=20 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Mean Neurocognitive Function (NCF) Composite Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy	-0.95 score on a scale Interval -2.12 to 0.21	-1.19 score on a scale Interval -2.03 to -0.33

SECONDARY outcome

Timeframe: Baseline and cycle 10 (approximately 46 weeks)

Population: Cycle 10 questionnaires were not completed by all QOL population participants progression-free at 6 months. Therefore, only 24/96 on the conventional arm and 22/95 on the dose-dense arm had data.

Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=24 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=22 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Mean EORTC QLQ-C30 Global Health Status Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy	73.3 score on a scale Interval 64.6 to 81.9	69.7 score on a scale Interval 60.1 to 79.3

SECONDARY outcome

Timeframe: Baseline and mid-cycle 1 (approximately 12 weeks)

Population: Questionnaires were not completed by all QOL population participants. Therefore, only 41/96 on the conventional arm and 35/95 on the dose-dense arm have both baseline and mid-cycle 1 data.

The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=41 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=35 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Mean Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Mid-cyle for Cycle 1	0.48 score on a scale Interval 0.06 to 0.9	0.39 score on a scale Interval -0.08 to 0.87

SECONDARY outcome

Timeframe: Baseline and mid-cycle 4 (approximately 24 weeks)

Population: Questionnaires were not completed by all QOL population participants. Therefore, only 32/96 on the conventional arm and 24/95 on the dose-dense arm have both baseline and mid-cycle 4 data.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=32 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=24 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Mean Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Mid-cyle for Cycle 4	-0.23 score on a scale Interval -0.69 to 0.23	0.19 score on a scale Interval -0.4 to 0.77

SECONDARY outcome

Timeframe: Baseline and mid-cycle 1 (approximately 12 weeks)

Population: Questionnaires were not completed by all QOL population participants. Therefore, only 40/96 on the conventional arm and 38/95 on the dose-dense arm have both baseline and mid-cycle 1 data.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=40 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=38 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Mid-cyle for Cycle 1	-4.58 score on a scale Interval -12.63 to 3.47	-2.63 score on a scale Interval -11.37 to 6.1

SECONDARY outcome

Timeframe: Baseline and mid-cycle 4 (approximately 24 weeks)

Population: Questionnaires were not completed by all QOL population participants. Therefore, only 30/96 on the conventional arm and 23/95 on the dose-dense arm have both baseline and mid-cycle 4 data.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=30 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=23 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Mid-cyle for Cycle 4	-2.78 score on a scale Interval -13.87 to 8.32	-0.72 score on a scale Interval -11.91 to 10.46

SECONDARY outcome

Timeframe: Baseline, 10,12, 22, 24, and 46 weeks

Population: Questionnaires were not completed by all QOL population participants. Therefore, the number of participants reported below are the number with the relevant questions answered at baseline and the given time point on each arm.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=96 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=95 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Change From Baseline in Mean EORTC QLQ-C30 Global Health Status Week 10 (Cycle 1)	0.0 score on a scale Interval -6.1 to 6.1	-2.9 score on a scale Interval -8.7 to 2.9
Change From Baseline in Mean EORTC QLQ-C30 Global Health Status Week 12 (Cycle 1.5)	-4.6 score on a scale Interval -12.6 to 3.5	-2.7 score on a scale Interval -11.3 to 6.1
Change From Baseline in Mean EORTC QLQ-C30 Global Health Status Week 22 (Cycle 4)	3.9 score on a scale Interval -2.5 to 10.4	-4.4 score on a scale Interval -12.1 to 3.3
Change From Baseline in Mean EORTC QLQ-C30 Global Health Status Week 24 (Cycle 4.5)	-2.8 score on a scale Interval -13.9 to 8.3	-0.7 score on a scale Interval -11.9 to 10.5
Change From Baseline in Mean EORTC QLQ-C30 Global Health Status Week 46 (Cycle 10)	5.4 score on a scale Interval -7.5 to 18.3	-1.9 score on a scale Interval -9.8 to 6.0

SECONDARY outcome

Timeframe: baseline and cycle 4 (approximately 22 weeks)

Population: Questionnaires were not completed by all QOL population participants. Therefore, only 51/96 on the conventional arm and 40/95 on the dose-dense arm have both baseline and cycle 4 data

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=51 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=40 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Cycle 4	5 Participants	11 Participants

SECONDARY outcome

Timeframe: baseline and cycle 4 (approximately 22 weeks)

Population: Questionnaires were not completed by all QOL population participants. Therefore, only 51/96 on the conventional arm and 40/95 on the dose-dense arm have both baseline and cycle 4 data

The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (did not interfere) to 10 (interfered completely). The symptom interference score is the average of the symptom interference items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=51 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=40 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Interference Score at Cycle 4	7 Participants	13 Participants

SECONDARY outcome

Timeframe: baseline and cycle 1 (approximately 10 weeks)

Population: Per the protocol, both arms are combined. Questionnaires were not completed by all QOL population participants. Therefore, only 136/191 have both MDASI-BT and EORTC QLQ-C30 at baseline and cycle 1.

* The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 (very poor) to 7 (excellent) such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). A score worse than baseline by at least 10 is considered deterioration. * The 2x2 frequency table of SS deterioration vs. GHS deterioration is presented as four rows.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=136 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 1 Symptom Severity and GHS deterioration	18 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 1 Symptom Severity deterioration only	9 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 1 GHS deterioratoin only	31 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 1 No deterioration	78 Participants	—

SECONDARY outcome

Timeframe: baseline and cycle 4 (approximately 22 weeks)

Population: Both arms are combined per the protocol. Questionnaires were not completed by all QOL population participants. Therefore, only 86/191 have both MDASI-BT and EORTC QLQ-C30 at baseline and cycle 4.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=86 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 4 Symptom Severity and GHS deterioration	10 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 4 Symptom Severity deterioration only	5 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 4 GHS deterioration Only	18 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 4 No deterioration	53 Participants	—

SECONDARY outcome

Timeframe: baseline and cycle 10 (approximately 46 weeks)

Population: Both arms are combined per the protocol. Questionnaires were not completed by all QOL population participants. Therefore, only 44/191 have both MDASI-BT and EORTC QLQ-C30 at baseline and cycle 10.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=44 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 10 Symptom Severity and GHS deterioration	5 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 10 Symptom Severity deterioration only	4 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 10 GHS deterioration only	5 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 10 No deterioration	30 Participants	—

SECONDARY outcome

Timeframe: Baseline, 10, 12, 22, 24, and 46 weeks

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=95 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=96 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score Over Time Baseline	1.3 score on a scale Interval 1.0 to 1.5	1.1 score on a scale Interval 0.8 to 1.4
Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score Over Time Week 10 (Cycle 1)	1.4 score on a scale Interval 1.1 to 1.7	1.4 score on a scale Interval 1.1 to 1.6
Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score Over Time Week 12 (Cycle 1.5)	1.6 score on a scale Interval 1.2 to 2.1	1.5 score on a scale Interval 1.1 to 1.8
Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score Over Time Week 22 (Cycle 4)	1.0 score on a scale Interval 0.7 to 1.3	1.2 score on a scale Interval 0.9 to 1.5
Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score Over Time Week 24 (Cycle 4.5)	1.0 score on a scale Interval 0.7 to 1.3	1.1 score on a scale Interval 0.7 to 1.6
Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score Over Time Week 46 (Cycle 10)	1.2 score on a scale Interval 0.7 to 1.6	1.1 score on a scale Interval 0.7 to 1.6

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.

Population: Both arms are combined per the protocol. Questionnaires/assessments were not completed by all QOL population participants. Therefore, only 154/191 have COWA, EORTC QLQ-C30, and HVLT-R baseline assessments (final model covariates)

Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30 subscales are calculated as the mean of component items, then standardized such that subscale scores range from 0 to 100. A high score for a functional scale represents a healthy level of functioning. Controlled Oral Word Association (COWA) score is the sum of correct responses with a range of 0 to infinity. A higher score indicates better functioning. Hopkins Verbal Learning Test - Revised (HVLT-R) score ranges from 0 to 36 for total recall is 0 to 36, 0 to 12 for delayed recall, and -12 to 12 for recognition. A higher score indicates better functioning.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=154 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Determination of Impactful Baseline Instruments on Overall Survival	17.5 months Interval 14.0 to 20.9	—

SECONDARY outcome

Timeframe: Baseline, 10, 22, and 46 weeks

Population: Questionnaires were not completed by all QOL population participants. Therefore, the number of participants reported below are the number with data at baseline and the given time point on each arm.

The NCF Composite score is the arithmetic mean of the HVLT-R (Free Recall, Delayed Recall, Delayed Recognition), TMTA, TMTB, and COWA scores, all of which are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. A participant must have at least 5 of the 6 scores. A higher composite score indicates better neurocognitive function.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=96 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ n=95 Participants Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Mean Neurocognitive Function (NCF) Composite Score Over Time Baseline	-1.2 score on a scale Interval -1.6 to -0.9	-1.5 score on a scale Interval -1.8 to -1.1
Mean Neurocognitive Function (NCF) Composite Score Over Time Week 10 (Cycle 1)	-1.3 score on a scale Interval -1.7 to -1.0	-1.45 score on a scale Interval -1.9 to -1.0
Mean Neurocognitive Function (NCF) Composite Score Over Time Week 22 (Cycle 4)	-1.1 score on a scale Interval -1.6 to -0.6	-1.3 score on a scale Interval -2.0 to -0.6
Mean Neurocognitive Function (NCF) Composite Score Over Time Week 46 (Cycle 10)	-1.0 score on a scale Interval -2.1 to 0.2	-1.2 score on a scale Interval -2.0 to -0.3

SECONDARY outcome

Timeframe: baseline and cycle 1 (approximately 10 weeks)

Population: Both arms are combined per the protocol. Questionnaires/assessments were not completed by all QOL population participants. Therefore, only 116/191 have both MDASI-BT and HVLT-R at baseline and cycle 1.

* The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * The HVLT-R Delayed Recognition raw score is the number of of correctly identified words minus the number of incorrectly identified words from a list of words including 12 nouns memorized 20 minutes prior. The raw score ranges from -12 to 12. with a higher score indicates better functioning. Scores are standardized (mean 0, standard deviation 1), adjusting for age,education, and gender as necessary. A score worse than baseline by at least two is considered deterioration. * The 2x2 frequency table of SS deterioration vs. HVLT-R deterioration is presented as four rows.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=116 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition Score at Cycle 1 Cognitive and HVLT-R deterioration	10 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition Score at Cycle 1 Cognitive deterioration only	12 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition Score at Cycle 1 HVLT-R deterioration only	20 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition Score at Cycle 1 No deterioration	74 Participants	—

SECONDARY outcome

Timeframe: baseline and cycle 4 (approximately 22 weeks)

Population: Both arms are combined per the protocol. Questionnaires/assessments were not completed by all QOL population participants. Therefore, only 71/191 have both MDASI-BT and HVLT-R at baseline and cycle 4.

* The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * The HVLT-R Delayed Recognition raw score is the number of of correctly identified words minus the number of incorrectly identified words from a list of words including 12 nouns memorized 20 minutes prior. The raw score ranges from -12 to 12. with a higher score indicates better functioning. Scores are standardized (mean 0, standard deviation 1), adjusting for age,education, and gender as necessary. A score worse than baseline by at least two is considered deterioration. * The 2x2 frequency table of SS deterioration vs. HVLT-R deterioration is presented as four rows.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=71 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 4 Cognitive and Delayed Recognition deterioration	3 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 4 Cognitive deterioration only	9 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 4 Delayed Recognition deterioration only	14 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 4 No deterioration	45 Participants	—

SECONDARY outcome

Timeframe: baseline and cycle 10 (approximately 46 weeks)

Population: Both arms are combined per the protocol. Questionnaires/assessments were not completed by all QOL population participants. Therefore, only 36/191 have both MDASI-BT and HVLT-R at baseline and cycle 10.

* The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * The HVLT-R Delayed Recognition raw score is the number of of correctly identified words minus the number of incorrectly identified words from a list of words including 12 nouns memorized 20 minutes prior. The raw score ranges from -12 to 12. with a higher score indicates better functioning. Scores are standardized (mean 0, standard deviation 1), adjusting for age,education, and gender as necessary. A score worse than baseline by at least two is considered deterioration. * The 2x2 frequency table of SS deterioration vs. HVLT-R deterioration is presented as four rows.

Outcome measures

Outcome measures
Measure	Conventional Adjuvant TMZ n=36 Participants Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.	Dose-dense Adjuvant TMZ Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 10 Cognitive and Delayed Recognition deterioration	3 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 10 Cognitive deterioration only	6 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 10 Delayed Recognition deterioration only	4 Participants	—
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 10 No deterioration	23 Participants	—

Adverse Events

No Adjuvant TMZ (Not Randomized)

Serious events: 105 serious events

Other events: 216 other events

Deaths: 0 deaths

Conventional Adjuvant TMZ

Serious events: 131 serious events

Other events: 376 other events

Deaths: 0 deaths

Dose-dense Adjuvant TMZ

Serious events: 142 serious events

Other events: 392 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld

Radiation Therapy Oncology Group (RTOG)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place