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| Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033254 |
Purpose
RATIONALE: 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.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without thalidomide in treating patients who have brain metastases.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: thalidomide Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Phase III Study Of Conventional Radiation Therapy Plus Thalidomide (NSC# 66847) Versus Conventional Radiation Therapy For Multiple Brain Metastases |
| Study Start Date: | June 2002 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least 1 measurable brain metastasis by MRI
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 258 Study Locations| Study Chair: | Jonathan P. S. Knisely, MD, FRCPC | Yale University |
More Information
| Study ID Numbers: | CDR0000069268, RTOG-BR-0118, RTOG-DEV-1006 |
| Study First Received: | April 9, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00033254 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult tumors metastatic to brain |
|
Anti-Bacterial Agents Immunologic Factors Thalidomide Neoplasm Metastasis |
Central Nervous System Neoplasms Angiogenesis Inhibitors Immunosuppressive Agents Nervous System Neoplasms |
|
Anti-Infective Agents Thalidomide Immunologic Factors Antineoplastic Agents Growth Substances Nervous System Diseases Physiological Effects of Drugs Central Nervous System Neoplasms Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions |
Anti-Bacterial Agents Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Therapeutic Uses Neoplasm Metastasis Growth Inhibitors Angiogenesis Modulating Agents Nervous System Neoplasms Leprostatic Agents |