Study of 3D Radiotherapy With or Without Erlotinib (Tarceva®) in Patients With Localized Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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A phase II, multicenter, randomized trial of 3D Radiotherapy versus 3D Radiotherapy and erlotinib (Tarceva®) in patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment, to compare safety and toxicity profile, and the progression-free survival in both arms of treatment (3D Radiotherapy versus 3D Radiotherapy + erlotinib) in patients who have not received previous chemotherapy.

Official Title
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Phase II Randomized Trial of 3D Radiotherapy Versus the Combination of 3D Radiotherapy and Erlotinib (Tarceva®) in Patients With Localized-Unresectable Non-Small Cell Lung Cancer Non Susceptible for Chemotherapy Treatment.

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Erlotinib (Tarceva®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent prior to any specific procedure of the protocol. Histologically confirmed diagnosis of non small cell lung cancer. Unresectable (IA-IIIB) non-small cell lung cancer. Patients non susceptible for chemotherapy treatment Measurable disease according to RECIST criteria Age > 18 years. ECOG performance status < 2. Adequate bone marrow, hepatic, renal and respiratory function. Patients capable of following an adequate therapeutic compliance and accessible for a correct follow-up. Women at a fertile age must have a negative serum or urine pregnancy test within the 7 days prior to the beginning of the treatment. Patients of both genders at a fertile age, including those women having their last menstruation within the two previous years, must follow effective contraceptive measures. Exclusion Criteria: Prior chemotherapy or radiotherapy. History of other curatively treated malignancy and no evidence of disease within the past 5 years except squamous cell skin cancer, or resected cervix carcinoma. Pregnant or lactating women. Any other severe disease or clinical conditions, as, but not only: Unstable cardiopathy despite treatment, myocardial infarction within the 6 months before entering the study Uncontrolled active infection Uncontrolled peptic ulcer, unstable diabetes mellitus or any other contraindication for treatment with corticosteroids. Autoimmune diseases. Concomitant treatment with any other antineoplastic therapy. Prior experimental pharmacological agent within the 3 weeks prior to the inclusion of the study. Prior treatment with EGFR targeted therapies. Erlotinib known hypersensibility. Any radiotherapy treatment contraindication. History of significant neurological or psychiatric disorders, including epileptic seizures. Any significant ophthalmologic impairment of the eye surface (Use of contact lenses is not recommended) Inability to take oral medication and surgical procedures affecting the absorption or implying intravenous or parenteral feeding. Any other underlying severe process affecting the ability to take part in the study.

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>RT + Tarceva | Drug: Erlotinib (Tarceva®)<br>* Erlotinib (Tarceva®), 150mg/day p.o during 6 months.<br>|
| No Intervention: 2<br>RT | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The progression-free survival. |  |  | 
| 1-year survival. |  |  | 
| Overall survival. |  |  | 
| Objective response rate, according to RECIST criteria. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, lung cancer, Patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment.