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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00377156
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of cerebral metastases meeting the following criteria:
* One to three presumed brain metastases
* Metastases must be from a histologically confirmed extracerebral site (e.g., lung, breast, prostate)
* Histologic confirmation may have been from the primary tumor site, from another metastatic site (e.g., osseous metastasis, adrenal metastasis), or from the metastatic brain lesion(s)
* Each lesion must measure less than 3.0 cm by contrast MRI of the brain performed within the past 21 days
* Lesions must not be within 5 mm of the optic chiasm or within the brainstem
* Eligibility for treatment with gamma knife or linear accelerator-based radiosurgery confirmed by a radiation oncologist
* No primary germ cell tumor, small cell carcinoma, or lymphoma
* No leptomeningeal metastases
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Male or female
* Menopausal status not specified
* ECOG performance status 0-2
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* Male patients must continue to use contraception for 3 months after the completion of radiotherapy
* No pacemaker or other MRI-incompatible metal in the body
* No known allergy to gadolinium
PRIOR CONCURRENT THERAPY:
* More than 7 days since prior and no concurrent chemotherapy
* No prior cranial radiotherapy
* No prior resection of cerebral metastases
* Concurrent hormonal agents, steroids, and/or anticonvulsants allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00377156
Study Brief:
Protocol Section:
NCT00377156