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

NCT01062425 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2022-07-26

Study results available
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Summary

This randomized phase II trial studies temozolomide, radiation therapy, and cediranib maleate to see how well they work compared with temozolomide, radiation therapy, and a placebo in treating patients with newly diagnosed glioblastoma (a type of brain tumor). Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether temozolomide and radiation therapy are more effective when given with or without cediranib maleate in treating glioblastoma.

Conditions

  • Adult Glioblastoma
  • Adult Gliosarcoma

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3-dimensional conformal radiotherapy

DRUG

Cediranib Maleate

Given PO

RADIATION

Intensity-Modulated Radiation Therapy

Undergo intensity-modulated radiation therapy

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Placebo Administration

Given PO

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

  • NRG Oncology

    collaborator OTHER

  • Radiation Therapy Oncology Group

    collaborator NETWORK

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Tracy T Batchelor · 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
2010-02-26
Primary Completion
2015-12-06
Completion
2022-05-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01062425 on ClinicalTrials.gov