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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT01066234
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed diagnosis of stage IIIA(N2) NSCLC that was completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve lobectomy through any incision (thoracoscopic or video-assisted thorascopic surgery approaches were acceptable)
2. "Pathologic N2" disease (involvement of N2 nodes can only be determined at the time of surgical exploration or postoperative pathologic analysis)
3. Age ≥18years
4. No known residual disease (negative resection margin and no extracapsular invasion of lymph node metastasis)
5. ECOG performance status of 0 to 1
6. No previous chemotherapy or RT
7. Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; creatinine clearance ≥ 50mL/min
8. Written informed consent form
Exclusion Criteria:
1. Patients with preoperative mediastinoscopic N2 positive disease
2. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
3. Patients with post-obstructive pneumonia or uncontrolled serious infection
4. Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
5. Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01066234
Study Brief:
Protocol Section:
NCT01066234