Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT04343157
Eligibility Criteria:
Inclusion Criteria:
1. Patients 18 years or older
2. One to three brain metastases targets, all smaller than 3 cm in diameter (intact or resected tumor bed)
3. Eastern cooperative Oncology Group (ECOG) performance status 0-2 (score of 0, no symptoms; 1, mild symptoms; 2, symptomatic, \<50% in bed during the day)
4. Ability to answer questions and follow commands via neurocognitive testing
5. Estimated life expectancy greater than 6 months
6. Pathologic confirmation of extracerebral tumor site (eg, lung, breast, prostate) from either the primary site or a metastatic lesion
7. Willingness/Ability to undergo brain MRI scans
8. Able to give informed consent
Exclusion Criteria:
1. Pregnant or nursing women
2. Women of childbearing potential unwilling to use adequate contraception
3. Inability to complete a magnetic resonance imaging scan with contrast
4. Tumor directly invading the critical area to be spared (for example a patient with tumor invading a critical white matter tract; ineligible for cognitive-sparing)
5. Planned chemotherapy during SRS (on the day of SRS)
6. Previous whole brain radiation therapy
7. Leptomeningeal metastases (ineligible for SRS)
8. Metastases from primary germ cell tumor, small cell carcinoma, or primary CNS lymphoma (ineligible for SRS)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04343157
Study Brief:
Protocol Section:
NCT04343157