Frontlight ResearchEarly access
CompletedNo phase
A Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases
Key facts
- Who runs it
- University Health Network, Toronto
- Where
- Canada and Germany2 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 30 people enrolled
- Started
- 19 Mar 2018
- Ended
- 10 Oct 2025
- Type of study
- Interventional
- Treatments tested
- Stereotactic Radiosurgery
- Record updated
- 4 March 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior cranial radiotherapy targeting the index lesion, or any prior WBRT
- 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)
- Inability to complete a MRI with contrast of the head, or a known allergy to gadolinium
- Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved
- pregnancy
- 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
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 assigned to receive neo-adjuvant stereotactic radiosurgery (NASRS).
The group in the trial
- Arm 1Other group
Neoadjuvant SRS
Treatment: Stereotactic Radiosurgery
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase II Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases
- Record updated
- 4 March 2026