Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme

Phase 2

Completed

• Conditions: Brain and Central Nervous System Tumors
• Interventions: Drug: carmustine; Radiation: radiation therapy; Radiation: stereotactic radiosurgery

• Registration Number: NCT00006386
• Lead Sponsor: Radiation Therapy Oncology Group

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by carmustine in treating patients who have supratentorial glioblastoma multiforme.

Detailed Description

OBJECTIVES:

* Determine the overall and progression-free survival in patients with supratentorial glioblastoma multiforme treated with accelerated radiotherapy and conformal stereotactic radiotherapy boost followed by carmustine.

* Determine the short and long-term toxicity of this regimen in these patients.

* Determine the feasibility of this regimen in these patients.

OUTLINE: Patients receive daily accelerated radiotherapy 5 days a week on weeks 1-2. On weeks 3-6, patients receive accelerated radiotherapy 4 days a week (3 days a week on week 6) and conformal stereotactic radiotherapy boost once weekly. Patients then receive carmustine IV over 1-2 hours on days 1-3 every 8 weeks for 6 courses beginning within 1 month after the completion of radiotherapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 15 months.

Study Timeline

• Study First Submitted: 2000-10-04
• Study Start: 2001-03
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-11
• Study Completion: 2009-02
• Status Verified: 2015-11
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
External beam radiotherapy with stereotactic boost	radiation therapy	External beam radiotherapy (EBXRT): 50 Gy in 25 daily fractions of 2 Gy. Stereotactic radiotherapy (SRT) boost: 4 treatments of 5 or 7 Gy, once per week during weeks 3-6. Patients will not receive EBXRT on the SRT treatment days.
External beam radiotherapy with stereotactic boost	stereotactic radiosurgery	External beam radiotherapy (EBXRT): 50 Gy in 25 daily fractions of 2 Gy. Stereotactic radiotherapy (SRT) boost: 4 treatments of 5 or 7 Gy, once per week during weeks 3-6. Patients will not receive EBXRT on the SRT treatment days.
External beam radiotherapy with stereotactic boost	carmustine	External beam radiotherapy (EBXRT): 50 Gy in 25 daily fractions of 2 Gy. Stereotactic radiotherapy (SRT) boost: 4 treatments of 5 or 7 Gy, once per week during weeks 3-6. Patients will not receive EBXRT on the SRT treatment days.

Primary Outcome Measures

Name	Time	Method
Overall Survival	From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	From registration to date of progression, death or last follow-up. Analysis occurs at the same time as the primary outcome analysis.

Trial Locations

Locations (236)

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Comprehensive Cancer Institute of Huntsville; 🇺🇸 Huntsville, Alabama, United States

Huntsville Hospital System; 🇺🇸 Huntsville, Alabama, United States

MBCCOP - Gulf Coast; 🇺🇸 Mobile, Alabama, United States

Alabama Oncology, LLC; 🇺🇸 Montgomery, Alabama, United States

DCH Cancer Treatment Center; 🇺🇸 Tuscaloosa, Alabama, United States

Foundation for Cancer Research and Education; 🇺🇸 Phoenix, Arizona, United States

Mount Diablo Medical Center; 🇺🇸 Concord, California, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Saint Agnes Cancer Center; 🇺🇸 Fresno, California, United States

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