A Phase II Study Analyzing Pre-Operative Stereotactic Radiosurgery Followed by Resection for Patients with 1-4 Brain Metastases

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study

This is a prospective, single arm, phase II trial to determine the local control at 6 months utilizing pre-operative stereotactic radiosurgery followed by surgery within 1 - 3 days in subjects with a diagnosis of 1-4 brain metastases and with an indication for surgical resection of at least one brain metastasis at the discretion of a neurosurgeon.

Detailed description of study

The purpose of this study is to evaluate 6 month in-brain local control utilizing pre-operative stereotactic radiosurgery followed by surgical resection for brain metastases.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: brain metastasis,solid tumor brain metastases,solid tumor,brain tumor,tumors,cancer,oncology
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
Radiographically confirmed solid tumor brain metastases
Criteria for surgical resection of at least one metastasis per neurosurgeon discretion
A diagnostic MRI Brain or CT Head demonstrating the presence of 1-4 solid tumor brain metastases and lesion to be resected no more than 5 cm in any direction, performed within 30 days prior to stereotactic radiosurgery. If multiple lesions are present, then the total brain metastases volume can be no more than 30 cm3 excluding the lesion to be resected.
Surgical candidate per neurosurgeon discretion 7. Surgical resection able to be performed within 1 - 3 days after radiosurgery
Stereotactic radiosurgery candidate per radiation oncologist
Patients currently on cytotoxic chemotherapy or immunotherapy are eligible, not including anti-VEGF therapy
Exclusion Criteria
Patients who received anti-VEGF therapy within 6 weeks prior to enrollment, as there is increased risk of fatal brain hemorrhage with surgical resection
Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up
Patients with more than 4 brain metastases on MRI Brain or CT Head
Lesion to be resected is more than 5 cm
Total volume of metastatic disease more than 30 cm3 excluding lesion to be resected
Patients with leptomeningeal metastases documented by MRI or CSF evaluation
Previous whole brain radiation therapy
Previous radiation therapy to lesion to be resected
Planned adjuvant focal therapy including additional radiation therapy to the brain
Not a surgical candidate per neurosurgeon's discretion
Not a radiosurgical candidate per radiation oncologist's discretion
Surgery unable to be performed between 1 - 3 days after radiosurgery
Women who are pregnant or nursing are not eligible as treatment involves unforeseeable risks to the fetus or child
Patients who have a known primary and have an estimated median survival less than 6 months per ds-GPA
Patients who have an unknown primary and have an estimated median survival less than 6 months per GPA

Updated on 04 Aug 2024. Study ID: 1707314702 (IUSCC-0627)

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