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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT01015534
Eligibility Criteria:
Inclusion Criteria:
* Karnofsky performance status (KPS) ≥ 50
* Life expectancy ≥ 12 weeks
* Histologically confirmed non lymphomatous solid tumors at primary site
* Brain metastases diagnosed with cranial MRI/CT.
* Extracranial metastases or primary tumor uncontrolled are allowed
* Hemoglobin ≥ 10 g/dl
* Absolute neutrophil count of \> 1500/mm3
* Platelet count of ≥ 100,000/mm3
* Blood urea nitrogen (BUN) ≤ 25 mg/dl,
* Serum creatinin ≤ 1.5 mg/dl
* Serum bilirubins ≤ 1.5 mg/dl,
* Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ twice the upper normal limit
Exclusion Criteria
* Pregnant or breast feeding woman
* History of allergic reaction to iodinated contrast media
* Inability to swallow
* Systemic chemotherapy in previous 3 weeks
* Oral chemotherapy in previous 2 weeks
* Prior surgery, chemotherapy, or radiotherapy for a brain neoplasm
* Meningeal carcinomatosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01015534
Study Brief:
Protocol Section:
NCT01015534