Pre-operative Hypofractionated Stereotactic Radiosurgery for Resectable Brain Metastases

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country49 target enrollmentMarch 11, 2022

ConditionsBrain Metastases Brain Lesion

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Brain Metastases
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Enrollment: 49
Locations: 1
Primary Endpoint: Time from Start of fSRS until Progression
Status: Active, Not Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 11, 2022

End Date

August 21, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Responsible Party

Sponsor

Eligibility Criteria

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) \>/=
•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 Childbearing Potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to the start of radiation therapy.
•Azoospermic males and WOCBP whoa re continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described.

Exclusion Criteria

•Participants who have germ cell tumors, primary brain tumor, or lymphoma
•Participants with symptoms related to brain metastases not able to be controlled with steroids.
•Women who are pregnant or breastfeeding
•Women of childbearing potential who are not using an effective method of contraception
•Participants deemed medically unfit to undergo surgical resection of brain metastasis by the treating neurosurgeon because of medical comorbidities, such as those who are neurologically or hemodynamically unstable despite appropriate medical interventions.
•Participants who have had whole brain radiation within the previous three months.
•Any prior cranial radiotherapy targeting the index lesion
•Index lesion located in the brainstem
•Any participants with the following imaging findings:
•Widespread definitive leptomeningeal metastasis Infratentorial mass effect with fourth ventricle effacement or hydrocephalus Supratentorial mass effect with greater than 10 mm of midline shift or hydrocephalus.

Outcomes

Primary Outcomes

Time from Start of fSRS until Progression

Time Frame: up to 12 months

Time from start of hypofractionated stereotactic radiosurgery until first occurrence of local progression of disease, or death. If none of these events occur, patients will be censored on date of last contact.