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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT00121420
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Karnofsky performance status (KPS) ≥ 70
* Histologically confirmed malignancy with the presence of one to four intraparenchymal brain metastases
* Each patient must sign a study-specific Informed Consent form
Exclusion Criteria:
* Previous cranial radiation
* Complete resection of all known brain metastases
* Known leptomeningeal metastases
* Known liver metastases
* Clinical or radiologic evidence of progression (other than study lesion\[s) within 1 month prior to enrollment
* Patients with metastases within 10 mm of the optic apparatus
* Patients with metastases in the brainstem, midbrain, pons, or medulla
* Planned chemotherapy during WBRT and/or SRS
* Uncontrolled hypertension
* Women who are pregnant or lactating
and Laboratory values as follows:
* LDH \> 1.3 x upper limit of normal (ULN)
* ANC \< 1500/mm3
* Platelets \< 50,000/mm3
* Creatinine \> 2.0 mg/dL
* AST or ALT \> 3 x ULN
* Total bilirubin \> 2 x ULN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00121420
Study Brief:
Protocol Section:
NCT00121420