Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases (NCT03741673) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases
United States180 participantsStarted 2018-11-08
Plain-language summary
This phase III trial studies stereotactic radiosurgery (SRS) before surgery to see how well it works compared with SRS after surgery in treating patients with cancer that has spread to the brain (brain metastases). SRS is the delivery of focused, high-dose radiation given in a single session to the tumors, with a minimal dose given to uninvolved areas of the brain.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The primary lesion pre-operatively can have a maximum diameter of =\< 4 cm for single fraction and =\< 7 cm for multifraction therapy
* Patients must be considered candidates for SRS within +/- 30 days of surgical resection as defined by either history and physical (H\&P) or presentation at brain metastasis tumor board conference note
* Patients must have a Karnofsky performance scores \>= 70 or Eastern Cooperative Oncology Group (ECOG) \>= 2 within 30 days of enrollment
* Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form
* No radiographic evidence of leptomeningeal disease on MD Anderson Cancer Center (MDACC) departmental radiology report or study neuro-radiologist review
* Documented history of malignancy
Exclusion Criteria:
* Patients who have received prior radiation therapy to the brain for any reason
* The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma
* For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.