NCT01891318

Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety (risk of acute and long-term toxicities) of neoadjuvant radiosurgery at escalating doses followed by surgical resection of brain metastases. (Phase I) II. To determine the local control of brain metastases treated with neoadjuvant radiosurgery followed by surgical resection. (Phase II) SECONDARY OBJECTIVES: I. To determine the rate of distant brain failure when brain metastases are managed with neoadjuvant radiosurgery followed by surgical resection. II. To estimate the rate of salvage surgery, whole brain radiation therapy (WBRT), or stereotactic radiosurgery (SRS) for participants treated with neoadjuvant radiosurgery followed by surgical resection. III. To determine the rate of radiation necrosis/steroid dependency. IV. To determine the radiobiologic impact of neoadjuvant radiosurgery for resected brain metastases. OUTLINE: This is a phase I, dose-escalation study of radiosurgery followed by a phase II study. The following outcomes were removed from the protocol in an amendment: * Changes in neurocognitive function as measured by the Hopkins Verbal Learning Test (HVLT), Controlled Oral Word Association (COWA) \& Trailmaking Test B, and Trailmaking Test A * QOL measured by FACT-BR and EORTC-QLQ30

Conditions

• Tumors Metastatic to Brain

Interventions

Type	Name	Description
RADIATION	radiosurgery	Undergo radiosurgery
PROCEDURE	therapeutic conventional surgery	Undergo surgical resection
PROCEDURE	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2013-07-03
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2013-07-03
• Last updated: 2025-07-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study