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:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT01872416
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients \>=18 years of age
2. the histological diagnosis of small cell lung cancer;
3. Patients who had first-line treatment failure or relapse after first-line therapy;
4. enough tumor tissue specimens for molecular marker analysis;
5. Measurable disease by RECIST criteria
6. ECOG performance status of \<=2.
7. Life expectancy of at least 3 months.
8. Laboratory values as follows:: ANC ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; HB ≥ 90g/L; serum bilirubin ≤ 1.5 upper limit of normal (N); ALT/AST≤ 2N (in patients with liver metastases :ALT/AST≤ 5N) creatinine≤1.25 N;and clearance rate of creatinine ≥ 60mLl/min; proteinuria \< 2+, or were detected in 24 hour urine protein, protein content is ≤1g
9. Patient must be accessible for treatment and follow-up
10. All patients must be able to understand the nature of the study and give written informed consent prior to study entry
Exclusion Criteria:
1. mixed small cell lung cancer;
2. patients had a previous diagnosis of malignant tumor;
3. HIV infection;
4. A history of cardiac disease as defined by malignant hypertension, unstable angina, congestive heart failure of \> grade 2 per New York Heart Association (NYHA) criteria, myocardial infarction within the previous 6 months, or symptomatic cardiac arrhythmias.
5. patients had the motor or sensory neurons lesions/symptoms of NCI - CTC AE \> 1;
6. patients had serious active infections;
7. patients were allergic to ifosfamide or liposomal doxorubicin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01872416
Study Brief:
Protocol Section:
NCT01872416