Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)

Study Overview
=================
Brief Summary
-----------------
Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.

Detailed Description
-----------------
Patients with non-resectable Non-small Cell Lung Cancer will receive thoracic radiation therapy 60-70 Gy over 30-35 fractions and concurrent with Erlotinib 150mg/day. Followed by Erlotinib 150 mg/day consolidation treatment.

Official Title
-----------------
A Phase II Study of Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer

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

Intervention / Treatment
-----------------
* Drug: Erlotinib
* Radiation: Thoracic radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc) Tumor EGFR mutation Presence of measurable disease by RECIST stage IIIA or IIIB, non-resectable ECOG performance status 0-2 No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital. Exclusion Criteria: Carcinoid tumor, small cell carcinoma of lung Patients with any distant metastasis History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment) Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women Women and men of childbearing potential who have no willing of employing adequate contraception Tumor EGFR wild

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Concomitant Erlotinib and radiotherapy<br>Patients received Erlotinib and radiation therapy. | Drug: Erlotinib<br>* Erlotinib 150mg/day<br>Radiation: Thoracic radiotherapy<br>* 60-70Gy/30-35f<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.) |  | After the thoracic radiotherapy and concurrent Erlotinib treatment | 
| The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.) |  | Every one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | The time from the start of treatment to diease progression | 
| The overall survival |  | The time from the start of treatment to death | 
| Quality of Life (QoL was evaluated according to the FACT-L.) |  | Every one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small cell lung cancer, EGFR-TKI, Erlotinib, Radiotherapy