Dysautonomia International

A Study of Stereotactic Radiosurgery (SRS) in People With Brain Cancer Having Tumor Resection Surgery

Purpose

The researchers are doing this study to see if treating people's brain tumors with stereotactic radiosurgery (SRS) before tumor resection surgery will prevent cancer cells from spreading to other areas of the brain, including the fluid and lining around the brain, during surgery, and lead to better surgical outcomes and fewer complications after surgery (post-surgery complications). Only one brain tumor (the index tumor) will be treated with the study radiosurgery and then removed by surgery. If there are other brain tumors, they will not be removed by surgery in this study, although they may be treated separately with standard radiation if the doctor decides it is needed.

Condition

Brain Metastasases

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Histologically or cytologically confirmed breast cancer, non-small cell lung cancer, melanoma, or gastrointestinal cancer. In malignancies for which tissue confirmation is not standard diagnostic practice (for example, hepatocellular carcinoma diagnosed by characteristic imaging), radiographic diagnosis consistent with standard of care is acceptable. In all cases, the intracranial lesion planned for resection undergoes pathologic examination as part of protocol-directed surgery. - At least one intact brain metastasis is planned for surgical resection that has not previously received stereotactic radiosurgery or other focal radiotherapy, measuring 6 cm or less in diameter. - No evidence of leptomeningeal disease based on clinical symptoms, MRI imaging of the brain or spinal cord, and/or lumbar puncture cytologic analysis. - No prior SRS to the index BM planned for surgical resection. Prior SRS to non- index lesions is permitted, with approval from the principal investigator. The interval since prior cranial radiotherapy will be recorded. All clinically significant toxicities from prior radiotherapy must have resolved to grade 1 or lower (CTCAE); patients with unresolved symptomatic (grade 2 or higher) radiation necrosis, treatment-related enhancing treatment effect, or clinically significant cerebral edema attributable to prior cranial radiation are not eligible. - No prior therapeutic craniotomy or craniectomy with biopsy. - Age ≥ 18 - Karnofsky Performance Status (KPS) of ≥ 70 and anticipated survival of >1 year - Ability to undergo contrast-enhanced MRI brain

Exclusion Criteria

Pregnant and/or breastfeeding - Prior whole brain radiotherapy. - Neurologic instability despite medical management, such that either the treating team or study investigators feel that urgent craniotomy without awaiting SRS is indicated. - Judgment by the principal investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Stereotactic RadioSurgery	Patients will be seen by an attending radiation oncologist before receiving SRS. Standard of are history and physical will be obtained. An MRI brain with contrast will be performed within seven days of the CT simulation for SRS planning. Surgical resection of the index lesion is to be performed within 10 days of SRS, and no later than 21 days to accommodate operating room availability.	Radiation: Stereotactic Radiosurgery Stereotactic Radiosurgery (SRS) to the index lesion will be delivered with standard of care technique at doses of 18Gy or 21Gy, for tumors >3cm and ≤3cm, respectively, in a single fraction. Procedure: Surgical Resection Patients will undergo standard-of-care surgical resection of the index lesion within 10 days of SRS, and no later than 21 days to accommodate operating room availability.

Recruiting Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920