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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