Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases
A Phase II Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases
This study is testing if giving a special type of radiation treatment before surgery can help people with one to six brain tumors do better and have fewer side effects than the usual treatments after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT03368625 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of neoadjuvant stereotactic radiosurgery (NASRS) for patients with one to six brain metastases, where at least one lesion is suitable for surgical removal. Participants will receive a single fraction of SRS before surgery, aiming to improve local control and reduce complications compared to traditional post-operative treatments. The trial is based on promising retrospective data showing lower rates of leptomeningeal failure and symptomatic radiation toxicity with this approach. The goal is to establish the value of NASRS in treating brain metastases that require resection.
Who should consider this trial
Good fit: Ideal candidates are patients with one to six brain metastases, with at least one lesion measuring between 2 cm and 4 cm that is deemed appropriate for surgical resection.
Not a fit: Patients with lymphoma, small cell carcinoma, or seminoma, as well as those with lesions not suitable for resection or previously treated with SRS, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with large brain metastases by enhancing local control and minimizing treatment-related side effects.
How similar studies have performed: Previous studies have shown promising results with similar neoadjuvant approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Toronto, Ontario and 1 other locations
- University Health Network — Toronto, Ontario, Canada (Recruiting)
- Charité Universitätsmedizin Berlin, Campus Virchow Klinikum — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: David Shultz, MD — University Health Network, Toronto
- Study coordinator: David Shultz, M.D.
- Email: david.shultz@rmp.uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.