Conditions: Non-small-cell Lung Cancer
Keywords: SCAT BRCA1 BRCA1 mRNA Levels ADJUVANT LUNG GECP-SCAT
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 500
Healthy volunteers: no

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

Arms:
arm 1: Control group:

\*Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: Four. arm 2: 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.

Interventions: intervention 1: Docetaxel/Cisplatin control intervention 2: Docetaxel intervention 3: Gemcitabine/Cisplatin intervention 4: Docetaxel/Cisplatin
Intervention descriptions: intervention 1: Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles intervention 2: Docetaxel 75 mg/m2 day 1, 4 cycles intervention 3: Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles intervention 4: Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles

Protocol document: