Erlotinib Concurrent With Radiation Therapy in Non-small-cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and efficacy of the concurrent use of erlotinib and radiation therapy in the treatment of locally advanced non-small lung cancer.

Detailed Description
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Non-small cell lung cancer (NSCLC) is still the leading cause of cancer death world-wide. Radiation therapy (RT) is one of the most important treatment choices in locally advanced NSCLC. Combination of RT and chemotherapy could improve treatment outcomes. However, the combined modality could not be used in many patients due to severe toxicities. EGFR-TKI shows great efficacy in the treatment of NSCLC, and many phase I/II studies established its safety in combination with RT. This phase II study is to further evaluate the efficacy and safety of the combination of RT and erlotinib in the treatment of locally advanced NSCLC. Eligible patients include patients with stage IIIA/IIIB NSCLC, who are not suitable for or refused to receive concurrent chemoradiotherapy. Eligible patients will receive oral erlotinib (150mg qd)throughout the course of thoracic RT (60-70 Gy). The primary endpoint is progression free survival and the second endpoints are overall survival and any grade III and above toxicities. We are going to recruit 50 patients for this study.

Official Title
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A Phase II Study on the Safety and Efficacy of Radiation Therapy and Concurrent Erlotinib in Locally Advanced Non-small-cell Lung Cancer

Conditions
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Carcinoma, Non-Small Cell Lung

Intervention / Treatment
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* Other: Radiation Therapy and EGFR-TKI target therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-70 years， Patients with stage IIIA-IIIB NSCLC adequate hematologic (WBC and platelet counts within normal limits), hepatic (total bilirubin level <= two times the upper limit of normal), and renal (creatinine clearance >= 50mL/min) functions No history of chemotherapy or less than 4 cycles neoadjuvant chemotherapy Can not tolerate or refuse concurrent chemoradiotherapy No history of thoracic RT Written informed consent obtained Exclusion Criteria: With other malignancy With severe cardiopulmonary disease Compromised liver or renal function that could not tolerate the combined therapy Received thoracic RT before Pregnant or breast-feeding women Present with active infection Uncontrolled diabetes Concurrent use of other anti-cancer agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined Treatment arm<br>All the patients received oral erlotinib and concurrent radiation therapy | Other: Radiation Therapy and EGFR-TKI target therapy<br>* Patients with locally advanced NSCLC received oral erlotinib (150 mg, qd) for about 6-7 weeks during the course of radiation therapy (60-70Gy in a fraction dose of 2 Gy, 5 fractions per week)<br>* Other names: Tarceva, Radiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of clinically definite disease progression |  | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality and any grade III and above toxicities |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small-cell lung cancer, Radiation therapy, Epidermal growth factor receptor, Tyrosine kinase inhibitor