Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With Brain Metastases

Completed · Not applicable

Conditions studied: Brain Metastases

In brief

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 - 4 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.

Key facts

Study ID

NCT03398694

Run by

Indiana University

People needed

50

Starts

2018-03-26

Expected to finish

2024-05-21

Last updated by the study team

2024-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• For known primary included in brainmetgpa.com, an estimated median survival no less than 6 months per brainmetgpa.com
• For unknown primary or known primary not included within brainmetgpa.com, an estimated median survival no less than 6 months per PI discretion Note: If patient's estimated median survival is calculated using a histology that is different than the histology demonstrated in final pathology, the patient may remain eligible for all study endpoints per PI discretion
• Surgical candidate per neurosurgeon discretion
• Surgical resection able to be performed within 1 - 4 days after radiosurgery
• Stereotactic radiosurgery candidate per radiation oncologist
• ≥ 18 years old at the time of informed consent
• Ability to provide written informed consent and HIPAA authorization. This will be assessed by the consenting physician using general questions to determine the patient's ability to understand the medical problem, proposed treatment, alternatives to proposed treatment, and understand the consequences of the medical choices.
• Platelet count > 100 k/cumm, Hgb > 7.5 gm/dL, INR < 1.3, ANC > 1.5 k/cumm
• Patients currently on cytotoxic chemotherapy or immunotherapy are eligible, not including anti-VEGF therapy
• If a patient who meets all stated eligibility criteria is enrolled on study and then discovered to be ineligible, the tissue obtained will still be deemed eligible to remain in study for evaluation.

You may not qualify if…

• 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 - 4 days after radiosurgery
• Women who are pregnant or nursing are not eligible as treatment involves unforeseeable risks to the fetus or child

Where it is running

• Indiana University Health Hospital — Indianapolis, Indiana, United States
• Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States
• Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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