The purpose of the study is to determine whether treatment with pre-operative hypofractionated stereotactic radiosurgery followed by surgery will improve time to local failure (TTLF) compared to the current standard of care.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed solid tumor malignancy other than lymphoma, or germ cell tumor. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician.
* Life expectancy must be deemed to be 3 months or more by a neurosurgeon, radiation oncologist, or medical oncologist with expertise in the treatment of metastatic cancer to the brain.
* Participants must have MRI evidence of \>/=1 brain metastasis no less than 10 mm and no greater than 60 mm in maximum diameter, deemed surgically resectable by neurosurgeon, not previously treated with Stereotactic Radiosurgery (SRS) or appropriate for fSRS.
* Each non-index lesion must be \</= 4.0 cm in maximal extent on contrasted MRI scan, and not otherwise require resection. The number of non-index lesions allowed will be at the treating physician's discretion, providing the use of whole brain radiotherapy is not used for treatment of these lesions.
* Participants must be either asymptomatic from their brain metastases or have symptoms which are well controlled with steroid medication.
* Systemic therapy such as immunotherapy, targeted therapy, or chemotherapy are permitted at treating physician's discretion.
* Karnofsky Performance Status (KPS) \>/=60.
* This study permits the re-enrollment of participant who has discontinued the study due to pre-treatment failure (i.e., the participant has not been treated). If re-enrolled, participant must be re-consented.
* Women of Childbearin…
What they're measuring
1
Time from surgery until Intracranial Progression
Timeframe: up to 12 months
Trial details
NCT IDNCT05267587
SponsorH. Lee Moffitt Cancer Center and Research Institute