Overview

Adjuvant CCRT vs CT in Minimal N2 NSCLC

Status:
Completed

Trial end date:
2021-01-18

Target enrollment:
0

Participant gender:
All

Summary

This study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Samsung Medical Center

Treatments:

Paclitaxel

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