Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor

Metastatic Cancer Clinical Trial

Official title: A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis

Status Recruiting

Clinical Trial Summary

RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in treating patients who are undergoing surgery to remove a metastatic brain tumor.

Clinical Trial Description

OBJECTIVES:

Primary

• Determine the 1-year local control rate in patients undergoing resection of a solitary brain metastasis comprising intraoperative radiotherapy using the INTRABEAM® system.

Secondary

• Determine the survival of patients treated with this therapy.

• Determine distant recurrence of disease in patients treated with this therapy.

• Determine the toxicity of this therapy in these patients.

• Determine the quality of life of patients treated with this therapy.

OUTLINE: This is a nonrandomized study.

Patients undergo surgical resection of a brain metastasis. Patients then undergo intraoperative radiotherapy using the INTRABEAM® system.

Quality of life is assessed at baseline and then every 3 months for 2 years.

Patients are followed within 48 hours after surgery, at 1 and 3 months, and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 31-62 patients will be accrued for this study. ;

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

• NCT number: NCT00107367
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 2004