Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma
|ClinicalTrials.gov Identifier: NCT00003308|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 23, 2013
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 or disease||Intervention/treatment||Phase|
|Kidney Cancer Melanoma (Skin) Metastatic Cancer Ovarian Cancer Sarcoma||Radiation: stereotactic radiosurgery||Phase 2|
- Evaluate whether the delivery of stereotactic radiosurgery without conventional whole brain radiotherapy is feasible in patients with 1-3 newly diagnosed brain metastases from renal cell carcinoma, melanoma, or sarcoma.
- Determine the 3-, 6-, and 12-month radiographic and neurologic intracranial patterns of progression (i.e., original lesions vs new lesions) in patients treated with this regimen.
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||September 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003308
|United States, Iowa|
|Iowa Methodist Medical Center|
|Des Moines, Iowa, United States, 50309|
|Mercy Medical Center|
|Des Moines, Iowa, United States, 50314|
|Iowa Lutheran Hospital|
|Des Moines, Iowa, United States, 50316-2301|
|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|
|Veterans Affairs Medical Center - Madison|
|Madison, Wisconsin, United States, 53705|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-0001|
|Australia, New South Wales|
|Westmead, New South Wales, Australia, 2145|
|Instituto de Enfermedades Neoplasicas|
|Lima, Peru, 34|
|San Juan City Hospital|
|San Juan, Puerto Rico, 00936-7344|
|Study Chair:||Minesh P. Mehta, MD||University of Wisconsin, Madison|