A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients With Resectable Brain Metastases
Objective
This phase III trial compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases.
Study Arms
Active Comparator: Arm I (surgery, stereotactic radiosurgery)
- Experimental: Arm II (stereotactic radiosurgery, surgery)
Eligibility
- Radiographic confirmation of 1-4 brain metastases, one of which requires resection, as defined by magnetic resonance imaging (MRI) with contrast obtained within 14 days prior to registration
- The maximum diameter of the lesion to be resected on the post-contrast MRI, as measured on any orthogonal plane (axial, sagittal, coronal), must measure > 2.0 cm and < 5.0 cm.
- The maximum diameter of the lesions not to be resected must measure < 4.0 cm
- Known active or history of invasive non-central nervous system (CNS) primary cancer based on documented pathologic diagnosis within the past 3 years
- All brain metastases must be located > 5 mm from the optic chiasm and outside the brainstem
- Patient is able to medically tolerate surgery and SRS
- The lesion chosen for surgical therapy must be deemed an appropriate target for safe, gross total resection by the treating surgeon
- History/physical examination within 14 days prior to registration
- Age >= 18
- Karnofsky performance status (KPS) >= 60 within 14 days prior to registration
- A negative urine or serum pregnancy test (in persons of childbearing potential) within =< 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal for at least 12 consecutive months
- Participants who are sexually active must agree to use medically acceptable forms of contraception during treatment on this study to prevent pregnancy
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
NCT ID
NCT05438212
