NCT00033254

Radiation Therapy With or Without Thalidomide in Treating Patients With Brain Metastases

A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (NSC#66847) Versus Conventional Radiation Therapy for Multiple Brain Metastases

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized phase III trial to compare the effectiveness of radiation therapy with or without thalidomide in treating patients who have brain metastases. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as thalidomide may stop the growth of brain metastases by stopping blood flow to the tumor. It is not yet known whether radiation therapy is more effective with or without thalidomide in treating brain metastases.

Detailed description

OBJECTIVES: I. Compare the overall survival of patients with multiple brain metastases treated with radiotherapy with or without thalidomide. II. Compare the time to tumor progression in patients treated with these regimens. III. Compare the time to neuro-cognitive progression in patients treated with these regimens. IV. Compare the cause of death distribution in patients treated with these regimens. V. Compare the frequency of toxic effects of these regimens in these patients. VI. Evaluate and compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to recursive partitioning analysis class (I vs II) and planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo radiotherapy once daily 5 days a week for 3 weeks. Arm II: Patients undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients receive oral thalidomide once daily. Treatment with thalidomide continues for 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at completion of radiotherapy, and then every 2 months for 1 year. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 332 patients (166 per treatment arm) will be accrued for this study within 14.5 months.

Conditions

• Tumors Metastatic to Brain

Interventions

Type	Name	Description
RADIATION	radiation therapy	Undergo conventional radiation therapy
DRUG	thalidomide	Given orally
PROCEDURE	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2002-03-01
• Primary completion: 2006-05-01
• First posted: 2003-01-27
• Last updated: 2020-10-30

Locations

1 site across 1 country: United States