Radiation Therapy and Tamoxifen in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme

Phase 2

Completed

• Conditions: Brain and Central Nervous System Tumors
• Interventions: Drug: tamoxifen citrate; Radiation: radiation therapy

• Registration Number: NCT00006388
• Lead Sponsor: Radiation Therapy Oncology Group

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as tamoxifen may make the tumor cells more sensitive to radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with tamoxifen in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.

Detailed Description

OBJECTIVES: I. Determine whether high-dose tamoxifen initiated at the beginning of conventional radiotherapy improves the median survival time of adults with newly diagnosed, supratentorial glioblastoma multiforme. II. Determine the feasibility and toxicity of high-dose tamoxifen in these patients. III. Determine the overall survival with respect to protein kinase C lab correlates in patients treated with this regimen.

OUTLINE: This is a multicenter study. Beginning within 5 weeks after surgery, patients undergo radiotherapy to the brain 5 days a week for 6 weeks. Patients receive high-dose oral tamoxifen every 6 hours beginning on day 1 of radiotherapy and continuing in the absence of disease progression. Patients are followed every 3 months through year 1, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 6 months.

Study Timeline

• Study First Submitted: 2000-10-04
• Study Start: 2000-12
• Primary Completion: 2003-10
• Study First Submitted QC: 2004-02-11
• Study First Posted: 2004-02-12
• Status Verified: 2015-11
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation plus Tamoxifen	tamoxifen citrate	-
Radiation plus Tamoxifen	radiation therapy	-

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.

Trial Locations

Locations (257)

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

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

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

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

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

Radiation Oncology Associates of West Alabama; 🇺🇸 Tuscaloosa, Alabama, United States

Providence Alaska Medical Center; 🇺🇸 Anchorage, Alaska, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

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

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