Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

Study Overview
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Brief Summary
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Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.

Detailed Description
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Randomized, phase III, predictive pharmacogenomic, open, prospective, international, multicenter study in patients with non-small-cell lung carcinoma (NSCLC) after complete resection and with N1 or N2 involvement

Official Title
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Phase III, Open, Multicenter and Randomized Study of Customized Adjuvant Chemotherapy Based on BRCA1 mRNA Levels in Completely Resected Stages II-IIIA Non-Small-Cell Lung Cancer Patients

Conditions
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Non-small-cell Lung Cancer

Intervention / Treatment
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* Drug: Docetaxel/Cisplatin
* Drug: Docetaxel
* Drug: Gemcitabine/Cisplatin
* Drug: Docetaxel/Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histological confirmation of non-small-cell lung carcinoma. Complete surgical resection of the disease. Tumoral tissue available for molecular analysis. N1 (stage II) or N2 (stage IIIA) lymph node involvement in the study of the operative piece. Men or women age 18 years or older. Patients with a performance status of 2 or less according to the ECOG classification. Patients with the following laboratory results: ANC < 1500/L, Hb < 10 g/dL, platelets <100,000/L, bilirubin < 1.0 mg/dL, AST and ALT < 1.5 upper limit of normality, creatinine clearance < 60 mL/min. Complete recovery from surgery within 6 weeks. Patients who have given written informed consent before initiating any specific study screening procedure. Exclusion Criteria: Patients who have received previously chemotherapy or radiotherapy for the study disease. Impossibility of complying with chemotherapy treatment due to cultural or geographic circumstances. Patients with active infection, heart disease, or any other serious disease, in the judgment of the investigator. Women who are pregnant or in the period of lactation. Patients with a previous diagnosis of malignant disease in the last five years except for carcinoma in situ of the uterine cervix or skin cancer other than melanoma. Patients under treatment with investigational agents.

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 |
| --- | --- |
| Active Comparator: 1<br> | Drug: Docetaxel/Cisplatin<br>* Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles<br>|
| Experimental: 2<br> | Drug: Docetaxel<br>* Docetaxel 75 mg/m2 day 1, 4 cycles<br>Drug: Gemcitabine/Cisplatin<br>* Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles<br>Drug: Docetaxel/Cisplatin<br>* Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate overall survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the disease-free survival, pattern of recurrences, toxicity profile and potential genetic markers of response and/or resistance to treatment. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LUNG, SCAT, BRCA1, BRCA1 mRNA Levels, ADJUVANT, GECP-SCAT