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

Phase 2

Completed

• Conditions: Sarcoma; Kidney Cancer; Ovarian Cancer; Metastatic Cancer; Melanoma (Skin)

• Registration Number: NCT00003308
• Lead Sponsor: Eastern Cooperative Oncology Group

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.

Study Timeline

• Study Start: 1999-02-02
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-09
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (14)

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

Scroll for more (4 remaining)