Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

Launched by CASE COMPREHENSIVE CANCER CENTER · Jun 28, 2013

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with brain metastases, which are tumors that have spread to the brain from other cancers. The trial is exploring whether combining a type of focused radiation treatment called radiosurgery with surgical removal of the tumor can help prevent these tumors from coming back. Researchers want to find the best dose of radiation to use and will also monitor any side effects from these treatments.

To be eligible for this trial, patients should have a confirmed diagnosis of cancer (except for certain types like small cell lung cancer or lymphoma) and have between one to four brain metastases that are within specific size limits. Patients should also be able to perform daily activities reasonably well. If you join the trial, you can expect to receive the combination of radiosurgery and surgery, followed by regular check-ups to monitor your progress. This study is currently recruiting participants, and it's important to note that anyone with certain medical conditions or previous treatments may not qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
• • Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion \> 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS
• • Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection
• • Patient must have a Karnofsky performance score of ≥ 70
• Exclusion Criteria:
• • Patient deemed medically unfit to undergo surgical resection of brain metastasis
• • Prior whole brain radiotherapy
• • Patient with contraindication for imaging with MRI
• • Inability to participate in study activities due to physical or mental limitations
• • Inability or unwillingness to return for all the required follow-up visits
• • At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
• • Tumor located in the brainstem
• • Imaging or cytologic evidence of leptomeningeal disease