Adjuvant CCRT vs CT in Minimal N2 NSCLC

Study Overview
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Brief Summary
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This study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC

Detailed Description
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Approximately 15% of patients with non-small cell lung cancer are diagnosed with stage IIIA-N2 disease. However, this subgroup is heterogeneous, with lymph nodes that are only microscopically invaded to those that are radiologically visible with bulky ipsilateral mediastinal lymph node involvement. Surgical resection in selected patients results in 5-year survival rates of 7-24%. The standard treatment for locally advanced clinical N2 disease is definitive concurrent chemoradiotherapy or induction chemotherapy (± radiation) followed by operation. However, in some patients, N2 status could be confirmed only after curative operation without any evidence of N2 diseases through preoperative evaluation methods (CT, PET, mediastinoscopy). We usually define those N2 disease found only after curative operation as microscopic N2, and do adjuvant chemotherapy, radiotherapy or concurrent chemoradiotherapy. However, little data about the adjuvant therapy for completely resected N2 disease have been available, Hence, we propose a randomized phase II study of adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC.

Official Title
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A Randomized Phase II Study of Adjuvant Concurrent Chemoradiotherapy vs Chemotherapy Alone in Completely Resected Microscopic N2 Non-small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: concurrent chemoradiotherapy
* Drug: chemotherapy only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Pathologic N2 disease (involvement of N2 nodes can only be determined at the time of surgical exploration or postoperative pathologic analysis) Age ≥18years No known residual disease (negative resection margin and no extracapsular invasion of lymph node metastasis) ECOG performance status of 0 to 1 No previous chemotherapy or RT 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 Written informed consent form Exclusion Criteria: Patients with preoperative mediastinoscopic N2 positive disease Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia Patients with post-obstructive pneumonia or uncontrolled serious infection Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: concurrent chemoradiotherapy<br> | Radiation: concurrent chemoradiotherapy<br>* weekly paclitaxel 50mg/m2 plus weekly cisplatin 25mg/m2 5times with concurrent radiotherapy (5000rad/25fx) for 5 weeks followed by 2 cycles of 3-weekly paclitaxel (175mg/m2) plus cisplatin 80mg/m2.<br>|
| Active Comparator: chemotherapy only<br> | Drug: chemotherapy only<br>* four cycles of 3-weekly paclitaxel (175mg/m2) and carboplatin (AUC5.5).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | 36 months | 
| Pattern of relapse |  | 36 months | 
| Toxicity profile |  | 36 months | 
| Quality of life (QOL) |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microscopic N2 Non-small Cell Lung Cancer, Paclitaxel, Carboplatin, Cisplatin