Brain Metastasases
Conditions
Keywords
Escalated Stereotactic radioSurgery, 26-304
Brief summary
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.
Interventions
RADIATIONStereotactic 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.
PROCEDURESurgical 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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| local failure | 1 year | pachymeningeal disease, classical leptomeningeal disease, symptomatic radiation necrosis, or death from any cause.to a composite adverse endpoint that includes This endpoint will be measured from date of receipt of SRS. These events are combined because they represent the totality of clinically meaningful central nervous system failure after resection and adjuvant radiation, are competing and partly related processes, and individually occur too infrequently to power a single-arm study. |
Countries
United States
Contacts
CONTACTLuke Pike, MD, PhD
CONTACTNelson Moss, MD
PRINCIPAL_INVESTIGATORLuke Pike, MD, PhD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed