Clinical trial · Interventional
Adjuvant CCRT vs CT in Minimal N2 NSCLC
A Randomized Phase II Study of Adjuvant Concurrent Chemoradiotherapy vs Chemotherapy Alone in Completely Resected Microscopic N2 Non-small Cell Lung Cancer
NCT01066234CI-TRIAL-00050805completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy only | Drug | — | UNRESOLVED |
| concurrent chemoradiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- concurrent chemoradiotherapy
- interventionNames
- Radiation: concurrent chemoradiotherapy
- type
- ACTIVE_COMPARATOR
- label
- chemotherapy only
- interventionNames
- Drug: chemotherapy only
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 36 months
Secondary outcomes (4)
- measure
- Overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSun JM, Noh JM, Oh D, Kim HK, Lee SH, Choi YS, Pyo H, Ahn JS, Jung SH, Ahn YC, Kim J, Ahn MJ, Zo JI, Shim YM, Park K. Randomized Phase II Trial Comparing Chemoradiotherapy with Chemotherapy for Completely Resected Unsuspected N2-Positive Non-Small Cell Lung Cancer. J Thorac Oncol. 2017 Dec;12(12):1806-1813. doi: 10.1016/j.jtho.2017.09.1954. Epub 2017 Sep 28. PMID 28962948