Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT04895592
Brief Summary:
This early phase I trial identifies the side effects of stereotactic radiosurgery before surgery in treating patients with cancer that has spread to the brain (brain metastases). Radiation may stimulate an anti-tumor immune response. Giving stereotactic radiosurgery before surgery may reduce the risk of the cancer coming back after surgery.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the safety of pre-operative stereotactic radiosurgery (SRS) followed by surgery for brain metastasis.
SECONDARY OBJECTIVES:
I. To evaluate the immune niche in brain metastasis following SRS in the presence of low or high dose dexamethasone.
II. To evaluate the impact of pre-operative SRS on survival outcomes.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM A: Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive low dose dexamethasone orally (PO) or intravenously (IV) for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
ARM B: Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive high dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
After completion of study intervention, patients are followed up for 120 days, and then every 12 weeks thereafter.
Study:
NCT04895592
Study Brief:
Protocol Section:
NCT04895592