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

NCT00884741 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 637

Last updated 2019-07-24

Study results available
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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.

Conditions

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3-dimentional conformal radiation therapy

BIOLOGICAL

Bevacizumab

Given IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo intensity-modulated radiation therapy

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Placebo

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Temozolomide

Given orally

Sponsors & Collaborators

  • Radiation Therapy Oncology Group

    collaborator NETWORK

  • NRG Oncology

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Mark Gilbert · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-15
Primary Completion
2013-03-17
Completion
2013-03-17

Countries

  • United States
  • Canada
  • Israel

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00884741 on ClinicalTrials.gov