Ovarian Cancer Clinical Trial

Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma

Summary

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.

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Full Description

OBJECTIVES:

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.

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Eligibility 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 have 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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00003308

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 14 Locations for this study

See Locations Near You

Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Mercy Medical Center
Des Moines Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
Alegent Health-Midlands Community Hospital
Papillion Nebraska, 68128, United States
MBCCOP - University of New Mexico HSC
Albuquerque New Mexico, 87131, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay Wisconsin, 54307, United States
Veterans Affairs Medical Center - Madison
Madison Wisconsin, 53705, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Westmead Hospital
Westmead New South Wales, 2145, Australia
Instituto de Enfermedades Neoplasicas
Lima , 34, Peru
San Juan City Hospital
San Juan , 00936, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00003308

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

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