NCT02798029

Frameless Fractionated Stereotactic Radiation in Treating Patients With Brain Metastases

A Phase II Study of the Efficacy, Safety, and Cost of Frameless Fractionated Stereotactic Radiation for Parenchymal Brain Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the safety and efficacy of frameless fractionated stereotactic radiation therapy for brain metastases. Frameless fractionated stereotactic radiosurgery is a specialized radiation therapy that delivers 3 to 5, high dose fractions of radiation directly to the brain lesions while sparing normal tissues.

Detailed description

PRIMARY OBJECTIVES: I. To assess the efficacy and safety of frameless fractionated stereotactic radiation therapy (FFSRT) on the treatment of solitary and oligometastatic brain metastases in the MD Anderson Houston Area Locations, MD Anderson Radiation Treatment Centers in New Mexico, MD Anderson affiliates and the main campus of MD Anderson, for patients unable or unwilling to undergo frame-based stereotactic radiosurgery (SRS). SECONDARY OBJECTIVES: I. To assess 6-month local control, intracranial progression-free survival and overall survival. II. To collect data on charges and reimbursements of patients treated with FFSRT to compare those charges and reimbursements if the same patients had been treated with single-fraction, frame-based gamma knife SRS. OUTLINE: Patients undergo FFSRT daily over 30 minutes for 3-5 days. After completion of study treatment, patients are followed up every 3 months for up to 1 year.

Conditions

• Metastatic Malignant Neoplasm in the Brain

Interventions

Type	Name	Description
RADIATION	Frameless Fractionated Stereotactic Radiation Therapy

Timeline

• Start date: 2016-08-08
• Primary completion: 2024-04-19
• Completion: 2024-04-19
• First posted: 2016-06-14
• Last updated: 2024-04-23

Locations

4 sites across 1 country: United States