Phase II Trial of Regimen for Stage III (N2) NSCLC Using Induction Treatment Followed by Resection

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that the Neoadjuvant Chemoradiotherapy was a beneficial treatment for Patients with Stage IIIA-N2 Non-Small Cell Lung Cancer, so we try to evaluate the security of treatment, the QoL of patients and the influence to the PFS and OS.

Detailed Description
-----------------
Scheme: Patients will receive different chemotherapy regimens depending on the pathological type. Squamous cell carcinoma:Docetaxel/Cisplatin and concurrent radiation (46Gy/23f) followed by surgery, consolidate Docetaxel/Cisplatin 2 cycles. Non-squamous cell carcinoma:Pemetrexed/Cisplatin and concurrent radiation (46Gy/23f) followed by surgery, consolidate Pemetrexed/Cisplatin 2 cycles.

Official Title
-----------------
A Prospective, Phase II Trial of a Trimodality Regimen for Stage III (N2) Non-small-cell Lung Cancer Using Concurrent Chemoradiotherapy as Induction Treatment Followed by Subsequent Resection

Conditions
-----------------
Non-small Cell Lung Cancer Stage IIIA

Intervention / Treatment
-----------------
* Other: Neoadjuvant Chemoradiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18≤Age≤65; ECOG performance status of 0 or 1; Pathological diagnosis with Stage IIIA-N2 NSCLC which is clinically resectable and the N2 is diagnosed by either mediastinoscopy,EBUS,PET/CT; WBC≥4.0×109/l, ANC≥1.5×109/l, PLT≥100.0×109/l, Hb≥90g/l;hepatorenal function is normal; Without a history of other malignancies before enrollment, except for non-melanoma skin cancer, in situ cervical cancer; The patient can understand the research and sign the informed consent. Exclusion Criteria: Female in pregnancy or lactating;Female of childbearing age without contraception; With acute infection or other serious underlying disease; With a significant history of neurological of psychiatric disease，including the dementia which may affect the ability to understand and sign the informed consent; Have received other treatment within the last 30 days before enrollment; With uncontrollable diabetes(blood glucose is unstable after treatment or FBG≥8mol/L).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant Treatment<br>Neoadjuvant Chemoradiotherapy | Other: Neoadjuvant Chemoradiotherapy<br>* Surgery followed by cisplatin-based regimen and concurrent radiation (46Gy/23f), consolidate the original regimen 2 cycles.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | observe and record the toxicity profile(including but not limit to mucositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edition) during the neoadjuvant chemoradiation and follow-up. | participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years | 
| QOL |  | up to 3 years | 
| OS |  | up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage IIIA-N2 NSCLC