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

Ovarian Cancer Clinical Trial

Official title:

A Phase II Trial of Radiosurgery for 1 to 3 Newly Diagnosed Brain Metastases From Renal Cell, Melanoma and Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003308
• Other study ID #: CDR0000066255
• Secondary ID: E-6397
• Status: Completed
• Phase: Phase 2
• Start date: February 2, 1999

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Melanoma
• Melanoma (Skin)
• Metastatic Cancer
• Ovarian Cancer
• Sarcoma

Intervention

Radiation:
• stereotactic radiosurgery

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales
Peru	Instituto de Enfermedades Neoplasicas	Lima
Puerto Rico	San Juan City Hospital	San Juan
United States	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Iowa Lutheran Hospital	Des Moines	Iowa
United States	Iowa Methodist Medical Center	Des Moines	Iowa
United States	Mercy Medical Center	Des Moines	Iowa
United States	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Veterans Affairs Medical Center - Madison	Madison	Wisconsin
United States	Alegent Health-Midlands Community Hospital	Papillion	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Peru,  Puerto Rico, 

References & Publications (1)

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: — View Citation