Trial · NCT00884741

Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma

NCT00884741, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2016-10-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma. Trials, record NCT00884741. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00884741

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma
NCT number: NCT00884741
Status: Completed
Phases: Phase 3
Enrollment: 637 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Glioblastoma, Gliosarcoma, Supratentorial Glioblastoma
Interventions: 3-Dimensional Conformal Radiation Therapy, Bevacizumab, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Placebo, Quality-of-Life Assessment, Temozolomide
First posted: 2009-04-21
Last updated: 2019-07-24
Results first posted: 2016-10-12

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival (OS)	From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.	Survival time was defined as time from randomization to date of death from any cause and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.
Primary	Progression-free Survival (PFS)	From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.	Progression-free survival was defined as time from randomization to date of progression, death, or last follow-up, and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.
Secondary	Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0	Up to 30 days	AEs are graded by using CTCAE 3.0. The difference between the two randomized arms in the percentage of patients with grade 3 or higher toxicities reported as possibly/probably/definitely related to protocol treatment will be tested using a chi square test.
Other	Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)	Analysis can occur at or after time of primary outcome measure analysis.
Other	Neurocognitive Function Measured by the Hopkins Verbal Learning Test-Revised(HVLT-R), Trail Making Test Part A, Trail Making Test Part B, Controlled Oral Word Association Test (COWAT)	Analysis can occur at or after time of primary outcome measure analysis.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS)	From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.	All eligible randomized patients	months	MEDIAN
PRIMARY	Progression-free Survival (PFS)	From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.	All eligible randomized patients	months	MEDIAN
SECONDARY	Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0	Up to 30 days	Eligible randomized patients with adverse event data who started study treatment.	participants	NUMBER
OTHER_PRE_SPECIFIED	Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)	Analysis can occur at or after time of primary outcome measure analysis.
OTHER_PRE_SPECIFIED	Neurocognitive Function Measured by the Hopkins Verbal Learning Test-Revised(HVLT-R), Trail Making Test Part A, Trail Making Test Part B, Controlled Oral Word Association Test (COWAT)	Analysis can occur at or after time of primary outcome measure analysis.

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Survival (OS)	Randomized Arm 1: TMZ+RT + Placebo	16.1	95% Confidence Interval 14.8 to 18.7	months
Overall Survival (OS)	Randomized Arm 2: TMZ+RT + Bevacizumab	15.7	95% Confidence Interval 14.2 to 16.8	months
Progression-free Survival (PFS)	Randomized Arm 1: TMZ+RT + Placebo	7.3	95% Confidence Interval 5.6 to 7.9	months
Progression-free Survival (PFS)	Randomized Arm 2: TMZ+RT + Bevacizumab	10.7	95% Confidence Interval 10.0 to 12.2	months
Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0	Randomized Arm 1: TMZ+RT + Placebo	87		participants
Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0	Randomized Arm 2: TMZ+RT + Bevacizumab	97		participants

Source ClinicalTrials.gov

Participant flow36

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Step 1 Registration: Tissue Screening	STARTED	Step 1 Registration	978
Step 1 Registration: Tissue Screening	STARTED	Step 2 Registration: Pre-Randomization TMZ+RT	0
Step 1 Registration: Tissue Screening	STARTED	Randomized Arm 1: TMZ+RT + Placebo	0
Step 1 Registration: Tissue Screening	STARTED	Randomized Arm 2: TMZ+RT + Bevacizumab	0
Step 1 Registration: Tissue Screening	COMPLETED	Step 1 Registration	666
Step 1 Registration: Tissue Screening	COMPLETED	Step 2 Registration: Pre-Randomization TMZ+RT	0
Step 1 Registration: Tissue Screening	COMPLETED	Randomized Arm 1: TMZ+RT + Placebo	0
Step 1 Registration: Tissue Screening	COMPLETED	Randomized Arm 2: TMZ+RT + Bevacizumab	0
Step 1 Registration: Tissue Screening	NOT COMPLETED	Step 1 Registration	312
Step 1 Registration: Tissue Screening	NOT COMPLETED	Step 2 Registration: Pre-Randomization TMZ+RT	0

1 to 10 of 36Source ClinicalTrials.gov

See all 36 participant flow

Adverse events813

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Blood disorder	Blood and lymphatic system disorders	Pre-Randomization TMZ+RT	0	10
other	Blood disorder	Blood and lymphatic system disorders	Randomized Arm 1: TMZ+RT + Placebo	20	300
other	Blood disorder	Blood and lymphatic system disorders	Randomized Arm 2: TMZ+RT + Bevacizumab	19	303
other	Hemoglobin decreased	Blood and lymphatic system disorders	Pre-Randomization TMZ+RT	2	10
other	Hemoglobin decreased	Blood and lymphatic system disorders	Randomized Arm 1: TMZ+RT + Placebo	124	300
other	Hemoglobin decreased	Blood and lymphatic system disorders	Randomized Arm 2: TMZ+RT + Bevacizumab	111	303
other	Leukopenia	Blood and lymphatic system disorders	Pre-Randomization TMZ+RT	0	10
other	Leukopenia	Blood and lymphatic system disorders	Randomized Arm 1: TMZ+RT + Placebo	98	300
other	Leukopenia	Blood and lymphatic system disorders	Randomized Arm 2: TMZ+RT + Bevacizumab	119	303
other	Lymphopenia	Blood and lymphatic system disorders	Pre-Randomization TMZ+RT	2	10

1 to 10 of 813Source ClinicalTrials.gov

See all 813 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pre-Randomization TMZ+RT
Total, all-cause mortality	Randomized Arm 1: TMZ+RT + Placebo
Total, all-cause mortality	Randomized Arm 2: TMZ+RT + Bevacizumab
Total, other adverse events	Pre-Randomization TMZ+RT	7	10
Total, other adverse events	Randomized Arm 1: TMZ+RT + Placebo	292	300
Total, other adverse events	Randomized Arm 2: TMZ+RT + Bevacizumab	292	303
Total, serious adverse events	Pre-Randomization TMZ+RT	5	10
Total, serious adverse events	Randomized Arm 1: TMZ+RT + Placebo	115	300
Total, serious adverse events	Randomized Arm 2: TMZ+RT + Bevacizumab	141	303

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24552317	DERIVED

Source PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180868	NRG Oncology Network Group Operations Center	WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S.	NRG ONCOLOGY FOUNDATION, INC.	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA021661	Radiation Therapy Oncology Group	CURRAN, WALTER J.	AMERICAN COLLEGE OF RADIOLOGY	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Randomized Arm 1: TMZ+RT + Placebo vs Randomized Arm 2: TMZ+RT + Bevacizumab: Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0

Source Trial comparisons

Tests4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Trail Making Test A	Other outcome	ConductCognition
Trail Making Test B	Other outcome	ConductCognition
Verbal Fluency	Other outcome	ConductCognition
Verbal Learning	Other outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00884741

GET https://conductscience.org/api/trials/v1/NCT00884741/flow?page=2

API reference For AI assistants