A Phase II Study Analyzing Pre-Operative Stereotactic Radiosurgery Followed by Resection for Patients with 1-4 Brain Metastases
Investigating Pre-Operative Stereotactic Radiosurgery for Brain Metastases
Brief description of study.
Detailed description of study
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
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Age: 18 years - 100 years
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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
This study investigates the use of pre-operative stereotactic radiosurgery followed by surgery in patients with brain metastases. Brain metastases occur when cancer cells spread to the brain from another part of the body. The goal is to evaluate how well this treatment approach controls the cancer in the brain six months after treatment.
Participants will undergo a procedure called stereotactic radiosurgery, which is a type of radiation therapy that precisely targets brain tumors. This will be followed by surgical removal of the tumor within 1 to 3 days. The study will assess the effectiveness of this treatment in controlling the brain metastases.
- Who can participate: Adults with 1 to 4 brain metastases confirmed by MRI or CT scan, who are candidates for both radiosurgery and surgical resection, are eligible. Patients must not have received anti-VEGF therapy within 6 weeks prior to the study.
- Study details: Participants will receive stereotactic radiosurgery, followed by surgery to remove brain tumors. This study does not involve a placebo.
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