NCT04069910

Stereotactic Radiation Therapy Before Surgery for the Treatment of Resectable Brain Metastases

Neoadjuvant Stereotactic Radiation Therapy for Resectable Brain Metastases

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well stereotactic radiation therapy before surgery works in treating patients with cancer that has spread to the brain (brain metastases) and can be removed by surgery (resectable). Stereotactic radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor, and may cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery may make the return of brain metastases less likely and help patients live longer compared to surgery followed by radiation therapy.

Detailed description

PRIMARY OBJECTIVE: I. To determine the rate of leptomeningeal failure after neoadjuvant radiation therapy (NaRT) versus (vs) postoperative stereotactic radiosurgery (SRS)/stereotactic radiation therapy (SRT). SECONDARY OBJECTIVES: I. Local control of brain metastases. II. Rate of salvage treatment including surgery, SRS, SRT, or whole brain radiation therapy (WBRT). III. Dose and volume of radiation to adjacent normal brain parenchyma. IV. Rate of symptomatic radiation necrosis/steroid dependency. V. Rate of distant brain failure. VI. To compare overall survival (OS) between the 2 groups. VII. To determine the number of patients who die due to neurologic causes. VIII. To assess quality of life as assessed using Functional Assessment of Cancer Therapy?Brain (FACT?BR). IX. To evaluate and compare the molecular makeup of tumor tissue in pre vs post radiation settings and determine differences in molecular and germline markers. X. To evaluate biomarkers and germline markers predicting response. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo 1, 5, or 10 fraction of SRS/SRT radiation. Surgery is performed within 72 hours of radiation therapy. ARM B: Within 2-5 weeks after standard of care surgery, patients undergo 1, 5, or 10 fraction of SRS/SRT. After completion of study treatment, patients are followed up every 3 months.

Conditions

• Malignant Neoplasm, Brain
• Brain Tumor

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Stereotactic Radiosurgery	Undergo SRS/SRT
PROCEDURE	Therapeutic Conventional Surgery	Undergo standard of care surgery

Timeline

• Start date: 2019-08-26
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2019-08-28
• Last updated: 2022-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study