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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00884741 |
Purpose
RATIONALE: 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. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to 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.
PURPOSE: This randomized phase III trial is studying temozolomide and radiation therapy to compare how well they work when given together with or without bevacizumab in treating patients with newly diagnosed glioblastoma. (gliosarcoma closed to accrual as of 07-13-10).
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: bevacizumab Drug: temozolomide Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 942 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients undergo radiotherapy (intensity-modulated radiotherapy or 3-dimensional conformal radiotherapy) once daily 5 days a week for 6 weeks and receive concurrent oral temozolomide once daily for up to 7 weeks. Beginning 4 weeks after completion of chemoradiotherapy, patients receive adjuvant oral temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive placebo IV over 30-90 minutes once every 2 weeks beginning in week 4 of chemoradiotherapy and continuing until the completion of adjuvant temozolomide.
|
Drug: temozolomide
Given orally
Other: placebo
Given IV
|
|
Experimental: Arm II
Patients undergo chemoradiotherapy and receive adjuvant temozolomide as in arm I. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning in week 4 of chemoradiotherapy and continuing until the completion of adjuvant temozolomide.
|
Biological: bevacizumab
Given IV
Drug: temozolomide
Given orally
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma (gliosarcoma closed to accrual as of 07-13-10)
Has undergone partial or complete surgical resection of tumor within the past 3-5 weeks
Has ≥ 1 block of tumor tissue of sufficient size available for analysis of MGMT status and determination of molecular profile
PATIENT CHARACTERISTICS:
No severe, active comorbidity, including any of the following:
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or radiosensitizers for cancer of the head and neck region
Concurrent full-dose anticoagulants (e.g., warfarin or low molecular weight heparin) allowed provided both of the following criteria are met:
Contacts and Locations
Show 229 Study Locations| Study Chair: | Mark R. Gilbert, MD | M.D. Anderson Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00884741 History of Changes |
| Other Study ID Numbers: | CDR0000640428, RTOG-0825 |
| Study First Received: | April 18, 2009 |
| Last Updated: | April 7, 2011 |
| Health Authority: | Unspecified |
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adult glioblastoma adult giant cell glioblastoma |
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |
Temozolomide Dacarbazine Bevacizumab Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |