Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)
- Conditions
- Non-small-cell Lung Cancer
- Interventions
- Drug: Docetaxel/Cisplatin controlDrug: DocetaxelDrug: Gemcitabine/CisplatinDrug: 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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
Hospital Severo Ochoa
🇪🇸Leganés, Madrid, Spain
Hospital de La Ribera
🇪🇸Alzira, Valencia, Spain
Hospital de Cruces
🇪🇸Baracaldo, Vizcaya, Spain
Hospital de Basurto
🇪🇸Bilbao, Vizcaya, Spain
H.G.U. Alicante
🇪🇸Alicante, Spain
Hospital de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital Univ. Sagrat Cor
🇪🇸Barcelona, Spain
Instituto Universitario Dexeus
🇪🇸Barcelona, Spain
Hospital Reina Sofía
🇪🇸Córdoba, Spain
Ico-Girona (Hospital Josep Trueta)
🇪🇸Girona, Spain
Hospital Virgen de Las Nieves
🇪🇸Granada, Spain
Hospital de Jaén
🇪🇸Jaén, Spain
Hospital de León
🇪🇸Leon, Spain
Hospital Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital de La Princesa
🇪🇸Madrid, Spain
Md Anderson Internacional
🇪🇸Madrid, Spain
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Carlos Haya
🇪🇸Malaga, Spain
Hospital Morales Messeguer
🇪🇸Murcia, Spain
Clínica Rotger
🇪🇸Palma de Mallorca, Spain
Hospital Son Dureta
🇪🇸Palma de Mallorca, Spain
Hospital Son Llátzer
🇪🇸Palma de Mallorca, Spain
Hospital Clinico de Salamanca
🇪🇸Salamanca, Spain
Hospital de Donostia
🇪🇸San Sebastián, Spain
Instituto Oncológico de San Sebastián
🇪🇸San Sebastián, Spain
Hospital Universitario de Canarias
🇪🇸Santa Cruz de Tenerife, Spain
H. Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital General de Valencia
🇪🇸Valencia, Spain
Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Hospital Provincial de Zamora
🇪🇸Zamora, Spain
Hospital Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain