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Radiation Therapy Plus Chemotherapy in Treating Patients With Supratentorial Glioblastoma Multiforme

Phase 3
Completed
Conditions
Brain and Central Nervous System Tumors
Registration Number
NCT00002545
Lead Sponsor
Radiation Therapy Oncology Group
Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy and carmustine in treating patients who have supratentorial glioblastoma multiforme.

Detailed Description

OBJECTIVES: I. Determine whether the use of radiosurgery (stereotactic external-beam irradiation) prior to conventional radiotherapy with carmustine (BCNU) improves overall survival compared to conventional radiotherapy plus BCNU alone in patients with supratentorial glioblastoma multiforme. II. Determine and compare the frequency and severity of toxicities associated with these regimens. III. Compare the effects of these two regimens on neurologic function and quality of life.

OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy. Tumor irradiation using megavoltage equipment (at least 4 MV photons); plus Carmustine, BCNU, NSC-409962. Arm II: Radiosurgery followed by Radiotherapy plus Single-Agent Chemotherapy. Stereotactic tumor irradiation; followed by tumor irradiation as in Arm I; plus BCNU.

PROJECTED ACCRUAL: 200 patients will be entered over approximately 3 years.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (260)

Veterans Affairs Medical Center - Birmingham

πŸ‡ΊπŸ‡Έ

Birmingham, Alabama, United States

University of Alabama Comprehensive Cancer Center

πŸ‡ΊπŸ‡Έ

Birmingham, Alabama, United States

Huntsville Hospital System

πŸ‡ΊπŸ‡Έ

Huntsville, Alabama, United States

Urology Associates - Mobile AL

πŸ‡ΊπŸ‡Έ

Mobile, Alabama, United States

MBCCOP - University of South Alabama

πŸ‡ΊπŸ‡Έ

Mobile, Alabama, United States

Alabama Oncology, LLC

πŸ‡ΊπŸ‡Έ

Montgomery, Alabama, United States

Radiation Oncology Associates of West Alabama

πŸ‡ΊπŸ‡Έ

Tuscallosa, Alabama, United States

Providence Cancer Therapy Center

πŸ‡ΊπŸ‡Έ

Anchorage, Alaska, United States

St. Joseph's Hospital and Medical Center

πŸ‡ΊπŸ‡Έ

Phoenix, Arizona, United States

Arizona Cancer Center

πŸ‡ΊπŸ‡Έ

Tucson, Arizona, United States

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Veterans Affairs Medical Center - Birmingham
πŸ‡ΊπŸ‡ΈBirmingham, Alabama, United States

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