NCT00478699

Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Spanish Lung Cancer Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel/Cisplatin control	Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
DRUG	Docetaxel	Docetaxel 75 mg/m2 day 1, 4 cycles
DRUG	Gemcitabine/Cisplatin	Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles
DRUG	Docetaxel/Cisplatin	Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles

Timeline

• Start date: 2007-06-01
• Primary completion: 2015-06-01
• Completion: 2015-07-01
• First posted: 2007-05-25
• Last updated: 2024-12-12
• Results posted: 2024-12-12

Locations

47 sites across 1 country: Spain