CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 637 enrolled
Drug / intervention
Bevacizumab +6 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00884741
NCT00884741Phase 3Completed

Phase III Double-blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

National Cancer Institute (NCI)·interventional·Posted Apr 21, 2009·Updated Jul 24, 2019

In Brief

A Phase 3 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Bevacizumab, and 5 other interventions for Glioblastoma and 2 related conditions. Completed, enrolled 637 participants across 330 sites in 3 countries.

Detailed Summary

This randomized phase III trial studies temozolomide (TMZ) and radiation therapy (RT) to compare how well they work with or without bevacizumab in treating patients with newly diagnosed glioblastoma or gliosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may find tumor cells and help kill them. It is not yet known whether temozolomide and radiation therapy are more effective when given together with or without bevacizumab in treating glioblastoma or gliosarcoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Israel, United States

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 21, 2009
Enrollment StartApr 15, 2009
Primary CompletionMar 17, 2013
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 17.2 years ago

Interventions

3-Dimensional Conformal Radiation Therapyradiation

Undergo 3-dimentional conformal radiation therapy

Bevacizumabbiological

Given IV

Intensity-Modulated Radiation Therapyradiation

Undergo intensity-modulated radiation therapy

Laboratory Biomarker Analysisother

Correlative studies

Placeboother

Given IV

Quality-of-Life Assessmentother

Ancillary studies

Temozolomidedrug

Given orally