Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
Docetaxel 75 mg/m2 day 1, 4 cycles
Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles
Estimated Overall Survival
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.
Time frame: 5 years
Disease Free Survival
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.
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
Hospital de Elche
Elche, Alicante, 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
Castellon, 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
Logroño, La Rioja, Spain
F.H.Alcorcon
Alcorcón, Madrid, Spain
Hospital Severo Ochoa
Leganés, Madrid, Spain
...and 37 more locations