Clinical Trials Directory

Trials / Completed

CompletedNCT00003308

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
—
Sponsor
Eastern Cooperative Oncology Group · Network
Sex
All
Age
18 Years – 120 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
RADIATIONstereotactic radiosurgery

Timeline

Start date
1999-02-02
Primary completion
2004-09-01
First posted
2003-01-27
Last updated
2023-06-22

Locations

14 sites across 4 countries: United States, Australia, Peru, Puerto Rico

Source: ClinicalTrials.gov record NCT00003308. Inclusion in this directory is not an endorsement.

Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma (NCT00003308) · Clinical Trials Directory