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 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT02772094
Eligibility Criteria:
Inclusion Criteria:
1. Histopathologically proved WHO grade-4 malignant glioma
2. Age: 13 years (physically mature) to 70 years
3. Karnofsky performance score before surgery: ≧70 \[Karnofsky 1951\] .
4. Adequate liver functions, including serum alanine aminotransferase (ALT or SGPT), serum aspartate aminotransferase (AST or SGOT), and alkaline phosphatase at ≤3.0 times upper limits of normal levels (ULN), total bilirubin ≤1.5mg/dl), total serum bilirubin \<3 mg/dl
5. Adequate renal function (BUN ≤25 mg/ml; creatinine≤1.8 mg/dl，creatinine clearance \>50 ml/min prior to starting therapy
6. Hemoblobin≧8 g/dl，platelet ≧100,000/μl，WBC\>2,000/μl; absolute neutrophil count \>1,000/μl
7. Prothrombin time and partial thromboplastin time≦1.5x the normal upper limit
Exclusion Criteria:
1. Pregnant or breast feeding
2. With radioactive implant
3. Acute infection, fever
4. Active collagen diseases
5. Acute cardiovascular diseases
6. Acute viral hepatitis
7. Syphilis
8. Human immunodeficiency virus (HIV) infection
9. Carrier of other transmissible infection
10. Immune deficiency due to chronic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
70 Years
Study:
NCT02772094
Study Brief:
Protocol Section:
NCT02772094