Status:
RECRUITING
A Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases
Lead Sponsor:
University Health Network, Toronto
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will be a non-randomized phase II trial for patients with one to six brain metastases, at least one of which is appropriate for surgical resection. Upon registration, patients will be assig...
Detailed Description
Recently, a novel treatment strategy for large brain metastases was described whereby lesions appropriate for resection were treated with a single fraction of SRS pre-operatively. In a retrospective a...
Eligibility Criteria
Inclusion
- Lymphoma, small cell carcinoma, and seminoma are excluded
- A lesion appropriate for resection, not previously treated with SRS. Lesions should be \> 2 cm and \< 4 cm in largest dimension, and require resection ( e.g. due to mass effect or to obtain a tissue diagnosis). Index lesions will be treated with SRS and surgery, as outlined in the treatment section of the protocol.
- Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for participation in this study, including the ability to tolerate NaSRS, e.g., the ability to lie flat in a stereotactic head frame.
- Any unresected lesions or lesions for which there is no planned immediate resection (non index lesions) must measure \< 3.0 cm in maximal extent on the contrasted MRI or CT brain scan obtained ≤ 35 days prior to pre-registration. Unresected lesions will be treated with SRS as outlined in the treatment section of the protocol. .
- ECOG ≤ 2
- MRI confirmed 1-6 lesions, one of which is the index lesion. Each non-index lesion (up to 5) must measure ≤ 3.0 cm in maximal extent on contrasted MRI scan, and not otherwise require resection.
- Note: The pre-registration MRI may be obtained ≤ 35 days prior to enrolment.
Exclusion
- Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved.
- pregnancy
- Prior cranial radiotherapy targeting the index lesion, or any prior WBRT.
- Inability to complete a MRI with contrast of the head, or a known allergy to gadolinium.
- Cytotoxic Chemotherapy within 7 days prior to SRS (molecularly targeted therapies , including immune-modulatory drugs, can be given within seven days of SRS at the discretion of the treating physician)
- Metastatic germ cell tumor, small cell carcinoma, or lymphoma or any primary brain tumor
- Imaging Findings:
- Widespread definitive leptomeningeal metastasis.
- A brain metastasis that is located ≤ 2 mm of the optic chiasm
- Evidence of midline shift
- Fourth ventricular narrowing, concerning for hydrocephalus
Key Trial Info
Start Date :
March 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03368625
Start Date
March 19 2018
End Date
December 1 2027
Last Update
February 20 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University Health Network
Toronto, Ontario, Canada, L4W4C2
2
Charité Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, Germany, 13353