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| Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003308 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients with newly diagnosed brain metastases from kidney cancer, melanoma, or sarcoma.
| Condition | Intervention | Phase |
|
Brain and Central Nervous System Tumors Kidney Cancer Melanoma (Skin) Ovarian Cancer Sarcoma |
Procedure: stereotactic radiosurgery |
Phase II |
| MedlinePlus related topics: | Cancer Kidney Cancer Melanoma Ovarian Cancer Soft Tissue Sarcoma |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Trial of Radiosurgery for 1 to 3 Newly Diagnosed Brain Metastases From Renal Cell, Melanoma and Sarcoma |
| Study Start Date: | July 1998 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to maximum tumor diameter (2 cm vs greater than 2 cm to 3 cm vs greater than 3 cm to 4 cm).
Patients undergo stereotactic radiosurgery at an assigned dose according to tumor diameter. Patients undergo MRI or CT scan at 3, 6, and 12 months after treatment or until disease progression.
All other therapies are allowed after stereotactic radiosurgery except external beam whole brain radiotherapy or resection of brain metastases, unless there is documented progression or unrelenting mass effect that necessitates craniotomy.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 7.2 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Iowa | |||||
| Iowa Lutheran Hospital | |||||
| Des Moines, Iowa, United States, 50316-2301 | |||||
| Iowa Methodist Medical Center | |||||
| Des Moines, Iowa, United States, 50309 | |||||
| Mercy Medical Center | |||||
| Des Moines, Iowa, United States, 50314 | |||||
| United States, Michigan | |||||
| CCOP - Kalamazoo | |||||
| Kalamazoo, Michigan, United States, 49007-3731 | |||||
| United States, Nebraska | |||||
| Alegent Health-Midlands Community Hospital | |||||
| Papillion, Nebraska, United States, 68128-4157 | |||||
| United States, New Mexico | |||||
| MBCCOP - University of New Mexico HSC | |||||
| Albuquerque, New Mexico, United States, 87131 | |||||
| United States, Ohio | |||||
| Ireland Cancer Center | |||||
| Cleveland, Ohio, United States, 44106-5065 | |||||
| United States, Pennsylvania | |||||
| Milton S. Hershey Medical Center | |||||
| Hershey, Pennsylvania, United States, 17033-0850 | |||||
| United States, Wisconsin | |||||
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | |||||
| Green Bay, Wisconsin, United States, 54307-3453 | |||||
| University of Wisconsin Comprehensive Cancer Center | |||||
| Madison, Wisconsin, United States, 53792-0001 | |||||
| Veterans Affairs Medical Center - Madison | |||||
| Madison, Wisconsin, United States, 53705 | |||||
| Australia, New South Wales | |||||
| Westmead Hospital | |||||
| Westmead, New South Wales, Australia, 2145 | |||||
| Peru | |||||
| Instituto de Enfermedades Neoplasicas | |||||
| Lima, Peru, 34 | |||||
| Puerto Rico | |||||
| San Juan City Hospital | |||||
| San Juan, Puerto Rico, 00936-7344 | |||||
| Eastern Cooperative Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Minesh P. Mehta, MD | University of Wisconsin, Madison |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
|
Manon R, O'Neill A, Knisely J, Werner-Wasik M, Lazarus HM, Wagner H, Gilbert M, Mehta M; Eastern Cooperative Oncology Group. Phase II trial of radiosurgery for one to three newly diagnosed brain metastases from renal cell carcinoma, melanoma, and sarcoma: an Eastern Cooperative Oncology Group study (E 6397). J Clin Oncol. 2005 Dec 1;23(34):8870-6.
  |
|
Mañon RR, Oneill A, Mehta M, et al.: Phase II trial of radiosurgery (RS) for 1 to 3 newly diagnosed brain metastases from renal cell, melanoma, and sarcoma: an Eastern Cooperative Oncology Group study (E6397). [Abstract] J Clin Oncol 22 (Suppl 14): A-1507, 108s, 2004.
  |
| Study ID Numbers: | CDR0000066255, E-6397 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003308 |
| Health Authority: | United States: Federal Government |
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