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Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma Clinical research trials and Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma. Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma clinical trial. Human subjects often receive the most effective healthcare possible for their Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma  Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma
Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma
For Condition: Cancer
Status: No longer recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: OBJECTIVES: - Evaluate whether the delivery of stereotactic radiosurgery without conventional whole brain radiation therapy 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 versus 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed renal cell carcinoma, melanoma, or sarcoma with 1-3 newly diagnosed intraparenchymal brain metastases based on contrast-enhanced MRI (CT scan acceptable if patients has a medical contraindication to MRI) - No lesion greater than 4.0 cm in diameter and, if multiple lesions are present, no more than one greater than 3.0 cm in diameter - No limitation on the extent of extracranial metastatic disease - No metastases in the brain stem, midbrain, pons, or medulla - No leptomeningeal metastases documented by MRI or CSF evaluation - No metastases within 10 mm of optic nerve or chiasm - No history of multiple liver metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 50,000/mm^3 - Hemoglobin greater than 8 g/dL Hepatic: - Not specified Renal: - Not specified Other: - No major medical illness - No psychoses - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Prior chemotherapy allowed - Systemic chemotherapy may be continued at the discretion of investigator after completion of radiosurgery Endocrine therapy: - Not specified Radiotherapy: - No prior cranial radiotherapy - Prior or concurrent radiotherapy to noncranial sites allowed Surgery: - No prior surgical resection for brain metastases - Prior stereotactic biopsy for diagnostic purposes allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MineshMehta, Study Chair, University of Wisconsin Comprehensive Cancer Center
Iowa Lutheran Hospital
Des Moines, Iowa, 50316-2301
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
United States
Instituto de Enfermedades Neoplasicas
Lima, , 34
Peru
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-0001
United States
San Juan City Hospital
San Juan, , 00936-7344
Puerto Rico
Mercy Medical Center
Des Moines, Iowa, 50314
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
Westmead Hospital
Westmead, New South Wales, 2145
Australia
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
United States
Alegent Health-Midlands Community Hospital
Papillion, Nebraska, 68128-4157
United States
Additional Information:
Study ID Numbers: CDR0000066255; E-6397
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003308
Other Cancer Studies:
1. High-Dose Chemotherapy, Total-Body Irradiation, and Autologous Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Hematologic Cancer or Solid Tumors
2. Collaborative Study of 1,3 Butadiene Biomarkers
3. Epirubicin, Carboplatin and Capecitabine in Adult Cancer Patients
4. A Phase I Study of ARQ 501 in Subjects with Cancer
5. Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction
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Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma
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