Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases
Recruiting
Phase 3
Interventional Study
Malignant Neoplasm
Metastatic Malignant Neoplasm in the Brain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 180 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 p…
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