Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced NSCLC.

Official Title
-----------------
A Randomized, Two Arm Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine, Nedaplatin, iV
* Radiation: 3DCRT
* Radiation: 3DCRT
* Drug: Gemcitabine，Nedaplatin, BAI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stage IIIA&IIIB NSCLC male or female, Age ≥18Years, ≤70Years Life expectation of at least 12weeks. PS performance 0-2 Measurable disease according to the Response Evaluation Criteria in Solid Tumours ( RECIST) Exclusion Criteria: Patient with prior chemotherapy or radiology for IIIA or IIIB NSCLC

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine, Nedaplatin,BAI plus 3DCRT<br>Gemcitabine(1000mg/m2)，Nedaplatin(60mg/m2),BAI, Day 1/4weeks. 4weeks per cycle. Tumor assessment will be perforemd after 2 cycles. if no PD, patient will be treated with 3DCRTfor 1 month. for patient PD after 3DCRT, complete the study. patient no PD after 3DCRT will receive 2 cycle of chemo with Gemcitabine. Nedaplatin. then patient will be followed for 1 year.. | Radiation: 3DCRT<br>* non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.<br>Drug: Gemcitabine，Nedaplatin, BAI<br>* Drug: Gemcitabine, Nedaplatin, iV Gemcitabine, Injection, 1000mg/m2, D1/4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles. BAI<br>|
| Other: Gemcitabine, Nedaplatin, IV Plus 3DCRT<br>Gemcitabine 100mg/m2, D1 & D8 every 4 weeks Nedaplatin 75mg/m2, D1 every 4 weeks. every 4 weeks per cycle. Tumor assessment will be performed after 2 cycles. if no PD, patient will be treated with 3DCRT for 1 month. for patient PD after 3DCRT, complete the study. patient no PD after 3DCRT will receive 2 cycle of chemo with Gemcitabine. Nedaplatin. then patient will be followed for 1 year. | Drug: Gemcitabine, Nedaplatin, iV<br>* Gemcitabine, Injection, 1000mg/m2, D1 & D7/ 4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles.<br>Radiation: 3DCRT<br>* non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Regular tumour assessments (based on RECIST criteria) for determining disease response and progression using CT and MRI scans, and overall survival.The primary efficacy variable is progression free survival (PFS), defined as the time between randomisation and the date of first documented disease progression or death from any cause, whichever comes first. Disease progression is defined according to the RECIST criteria. | every 2 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | after Progressive Disease, patient will be contact every 3 month for the survival information. | every 3 month after Progressive Disease | 
| Time to Progressive Disease (RECIST Criteria) | Regular tumour assessments (based on RECIST criteria) for determining disease response and progression using CT and MRI scans.Time to Progression (TTP) is defined as the time between randomisation and the date of the first documented disease progression. | Every 2 cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BAI, 3DCRT