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

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003308

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer Melanoma (Skin) Metastatic Cancer Ovarian Cancer Sarcoma	Radiation: stereotactic radiosurgery	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Primary Purpose:

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 :

Jul 1, 1998

Actual Primary Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
2	Mercy Medical Center	Des Moines	Iowa	United States	50314
3	Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316-2301
4	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
5	Alegent Health-Midlands Community Hospital	Papillion	Nebraska	United States	68128-4157
6	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico	United States	87131
7	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
8	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
9	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin	United States	54307-3453
10	Veterans Affairs Medical Center - Madison	Madison	Wisconsin	United States	53705
11	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-0001
12	Westmead Hospital	Westmead	New South Wales	Australia	2145
13	Instituto de Enfermedades Neoplasicas	Lima		Peru	34
14	San Juan City Hospital	San Juan		Puerto Rico	00936-7344