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Sponsored by: |
Allos Therapeutics |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005887 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the brain with or without RSR13 in treating patients who have brain metastases.
Condition | Intervention | Phase |
---|---|---|
Metastatic Cancer |
Drug: efaproxiral Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases |
Study Start Date: | February 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, open label, comparative, multicenter study. Patients are stratified according to the Radiation Therapy Oncology Group RPA Class (I vs II). Patients are further stratified within the RPA class II stratum according to site of primary cancer (non-small cell lung cancer vs breast vs other). Patients are randomized to one of two treatment arms.
Patients are followed at 1 month, 3 months, every 3 months until disease progression, and then for survival.
PROJECTED ACCRUAL: A maximum of 408 (204 per treatment arm) patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Radiographically, histologically, or cytologically confirmed brain metastases with histologically or cytologically confirmed primary malignancy except the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Edward G. Shaw, MD | Wake Forest University |
Study ID Numbers: | CDR0000067957, ALLOS-RSR13RT-009 |
Study First Received: | June 2, 2000 |
Last Updated: | August 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00005887 History of Changes |
Health Authority: | United States: Federal Government |
tumors metastatic to brain |
Radiation-Sensitizing Agents Neoplasm Metastasis Efaproxiral |
Neoplasms Neoplastic Processes Antisickling Agents Pathologic Processes Radiation-Sensitizing Agents Therapeutic Uses |
Physiological Effects of Drugs Hematologic Agents Neoplasm Metastasis Pharmacologic Actions Efaproxiral |