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

NCT ID: NCT00003308

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-02-02

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.

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.

Conditions

Kidney Cancer; Melanoma (Skin); Metastatic Cancer; Ovarian Cancer; Sarcoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

stereotactic radiosurgery

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

Minesh P. Mehta, MD

Role: STUDY_CHAIR

University of Wisconsin, Madison

Locations

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Mercy Medical Center

Des Moines, Iowa, United States

Iowa Lutheran Hospital

Des Moines, Iowa, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

Alegent Health-Midlands Community Hospital

Papillion, Nebraska, United States

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, United States

Ireland Cancer Center

Cleveland, Ohio, United States

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, United States

Veterans Affairs Medical Center - Madison

Madison, Wisconsin, United States

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Westmead Hospital

Westmead, New South Wales, Australia

Instituto de Enfermedades Neoplasicas

Lima, , Peru

San Juan City Hospital

San Juan, , Puerto Rico

Countries

United States; Australia; Peru; Puerto Rico

References

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. doi: 10.1200/JCO.2005.01.8747.

Reference Type: RESULT

PMID: 16314647 (View on PubMed)

Other Identifiers

E-6397

Identifier Type: -

Identifier Source: secondary_id

CDR0000066255

Identifier Type: -

Identifier Source: org_study_id