Radiotherapy Combined With Iressa for EGFR Mutation Positive Patients With Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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The purpose of this study is to access the effect and safety of radiotherapy combined whth Iressa for patients with locally advanced non-small cell lung cancer with harboring active EGFR mutations.

Detailed Description
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Worldwide more than half a million new cases of lung cancer are diagnosed annually. About 80% of these tumours are of non-small cell histological type. Surgery is the treatment of choice, but only about 20% of tumours are suitable for potentially curative resection. Concurrent chemoradiotherapy is the standard treatment for locally advanced NSCLC. When Iressa was used in the first-line treatment of advanced NSCLC with EGFR mutations positive, the 12-month rates of progression-free survival were 24.9%. Therefore, we speculate that the EGFR mutations in patients with locally advanced NSCLC, Gefitinib combined with radiotherapy may be better than chemoradiotherapy. We design the study to access the effect and safety of radiotherapy combined whth Iressa for patients with locally advanced non-small cell lung cancer with harboring active EGFR mutations.

Official Title
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A Phase II Trial of Radiation Therapy Combined With Iressa in Patients With Locally Advanced Non-small Cell Lung Cancer With Harboring Active EGFR Mutations

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Other: Gefitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed diagnosis of non-squamous NSCLC; Stage ⅢA-ⅢB(not suitable for surgery) or stage Ⅳ(only single-site single transfer ); Untreated patients, or who completed ≤ 2 cycles of first-line chemotherapy (chemotherapy regimen: paclitaxel, docetaxel + cisplatin) within the previous month; Patients with tumor EGFR mutation positive (exon 19 deletion mutation or exon 21 L858R substitution mutation); Patients must be informed of the investigational nature of the study and must sign an informed consent form; Presence of at least one measurable/evaluable according to RECIST criteria. ECOG performance Status 0-2 ; Patients must have a life expectancy > 12 weeks; Patients with laboratory values as follows:WBC>4.0 x 109/L; ANC≥1.5 x 109/L; PLT≥100 x 109/L; HGB≥10 g/dL; CR≤1.5 x ULN; TBIL<1.5 x ULN; AST and ALT≤1.5 x ULN; LDH≤1.5 x ULN; AKP≤5 x ULN; FEV 1≥1.0L and >50% Corresponding normal values; Patient candidate to standard platinum-based chemotherapy; Patients must be nonpregnant and non-lactating.Patients of childbearing potential must implement an effective method of contraception during the study. All female Patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test. Exclusion Criteria: Any evidence of clinically active interstitial lung disease; Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uterine and squamous cell carcinoma of the skin； Pregnancy or lactating； Serious concomitant infection; MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia; As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease); Patients who are not suitable to participate in the trial according to researchers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy Combined With Gefitinib<br> | Other: Gefitinib<br>* Radiation Therapy: 3D-CRT/IMRT 95%PTV 60-66Gy, 1.8-2.0Gy/f,5f/w; Gefitinib: 250 mg, Qd, p.o;<br>* Other names: Iressa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (RR) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) |  | 2 years | 
| Overall survival (OS) |  | 2 years | 
| Quality of life (MD-Anderson questionnaire) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally Advanced NSCLC, EGFR Mutation Positive, Radiotherapy combined Gefitinib