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:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT00107367
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan
* Resectable disease
* Histological evidence of metastatic carcinoma by intraoperative pathology
* No primary lymphoma, germ cell carcinoma, or small cell lung cancer
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 70-100%
Life expectancy
* At least 3 months
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No uncontrolled hypertension
* No unstable angina pectoris
* No uncontrolled dysrhythmias
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No serious infection
* No other medical illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior temozolomide or polifeprosan 20 with carmustine implant (Gliadel® wafer) for brain metastasis
Endocrine therapy
* Not specified
Radiotherapy
* No prior brain radiotherapy of any kind, including local or whole brain external beam radiotherapy, brachytherapy, or stereotactic radiosurgery
* No concurrent external beam radiotherapy to the brain
* Not planning adjuvant whole brain radiotherapy after study therapy
Surgery
* Not specified
Other
* No other prior conventional or investigational local or systemic agents for brain metastasis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00107367
Study Brief:
Protocol Section:
NCT00107367