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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00304031 |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known which schedule of temozolomide when given together with radiation therapy is more effective in treating glioblastoma or gliosarcoma.
PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed glioblastoma or gliosarcoma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: temozolomide Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma |
Estimated Enrollment: | 834 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.
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Drug: temozolomide
Given orally
Radiation: radiation therapy
Patients undergo radiotherapy daily, 5 days per week for 6 weeks.
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Arm II: Experimental
Patients receive oral temozolomide on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.
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Drug: temozolomide
Given orally
Radiation: radiation therapy
Patients undergo radiotherapy daily, 5 days per week for 6 weeks.
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to recursive partitioning analysis class (III vs IV vs V), MGMT gene methylation status (methylated vs nonmethylated vs indeterminate), and radiotherapy criteria used (standard vs revised European).
Patients undergo radiotherapy daily, 5 days per week for 6 weeks. Patients also receive oral temozolomide daily during radiotherapy. Patients are then randomized to 1 of 2 treatment arms. Randomized treatment begins approximately 4 weeks after completion of radiotherapy.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 2 years, and then every 6 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 834 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven glioblastoma or gliosarcoma
Diagnosis must be made by open biopsy or tumor resection
Contrast-enhanced MRI or CT scan (if MRI is not available) of the brain must be performed preoperatively and postoperatively prior to initiation of radiotherapy, within 28 days prior to study entry
Meets 1 of the following recursive positioning analysis classifications:
Class III
Class IV, meeting 1 of the following criteria:
Class V, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
No severe, active comorbidity, including any of the following:
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or radiosensitizers (including polifeprosan 20 with carmustine implant [Gliadel wafers] or any other intratumoral or intracavitary treatment) for cancers of the head and neck region
Study Chair: | Mark R. Gilbert, MD | M.D. Anderson Cancer Center |
Investigator: | Minesh P. Mehta, MD | University of Wisconsin, Madison |
Study Chair: | Roger Stupp, MD | Centre Hospitalier Universitaire Vaudois |
Responsible Party: | Radiation Therapy Oncology Group ( Walter John Curran, Jr ) |
Study ID Numbers: | CDR0000465183, RTOG-0525, EORTC-26052, EORTC-22053 |
Study First Received: | March 15, 2006 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00304031 History of Changes |
Health Authority: | Unspecified |
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Adjuvants, Immunologic Central Nervous System Neoplasms Temozolomide Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Antineoplastic Agents, Alkylating Gliosarcoma Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Astrocytoma Antineoplastic Agents Nervous System Diseases Neoplasms, Nerve Tissue Central Nervous System Neoplasms Temozolomide Pharmacologic Actions Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Antineoplastic Agents, Alkylating Glioma Neoplasms, Neuroepithelial Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |