Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

Phase 3

Completed

• Conditions: Non-small-cell Lung Cancer
• Interventions: Drug: Docetaxel/Cisplatin control; Drug: Docetaxel; Drug: Gemcitabine/Cisplatin; Drug: Docetaxel/Cisplatin

• Registration Number: NCT00478699
• Lead Sponsor: Spanish Lung Cancer Group

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2007-05-24
• Study First Submitted QC: 2007-05-24
• Study First Posted: 2007-05-25
• Study Start: 2007-06
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Results First Submitted: 2022-05-31
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Results First Posted: 2024-12-12
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Control group	Docetaxel/Cisplatin control	Control group: \*Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: Four.
2 Experimental group	Docetaxel	Experimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments: * Low expression of BRCA1 → gemcitabine 1250 mg/m2, days 1 and 8, and cisplatin 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4 * Intermediate expression levels of BRCA1 → docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total cycles: 4. * High expression levels of BRCA1 → docetaxel 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4.
2 Experimental group	Gemcitabine/Cisplatin	Experimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments: * Low expression of BRCA1 → gemcitabine 1250 mg/m2, days 1 and 8, and cisplatin 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4 * Intermediate expression levels of BRCA1 → docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total cycles: 4. * High expression levels of BRCA1 → docetaxel 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4.
2 Experimental group	Docetaxel/Cisplatin	Experimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments: * Low expression of BRCA1 → gemcitabine 1250 mg/m2, days 1 and 8, and cisplatin 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4 * Intermediate expression levels of BRCA1 → docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total cycles: 4. * High expression levels of BRCA1 → docetaxel 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4.

Primary Outcome Measures

Name	Time	Method
Estimated Overall Survival	5 years	To assess and compare the overall survival estimated at 5 years of both treatment groups (Control arm vs Experimental arm).; Overall survival:The proportion of participants in treatment group who are still alive for a certain period of time after inclusion.

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival	5 years	To assess the disease-free survival of both treatment groups. Disease-free survival: will be calculated from the date of surgery until there is some clinical evidence of disease progression or the date of death due to the disease.

Trial Locations

Locations (47)

Hospital de Elche; 🇪🇸 Elche, Alicante, Spain

Hospital Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Ico - H. Germans Trias I Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital D'Althaia; 🇪🇸 Manresa, Barcelona, Spain

Hospital de Mataró; 🇪🇸 Mataró, Barcelona, Spain

Hospital Provincial de Castellón; 🇪🇸 Castellón De La Plana, Castellón, Spain

Hospital Insular de Gran Canaria; 🇪🇸 Las Palmas de Gran Canaria, GRAN Canaria, Spain

Hospital Clin. Univ. Santiago de Compostela; 🇪🇸 Santiago de Compostela, LA Coruna, Spain

Hospital San Pedro; 🇪🇸 Logrono, LA Rioja, Spain

F.H.Alcorcon; 🇪🇸 Alcorcon, Madrid, Spain

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