drugset / Trial / NCT00478699

Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

NCT00478699 ↗

Phase 3 Completed 500 enrolled Spanish Lung Cancer Group
RandomizedParallel-groupOpen-labelTreatment

Summary

Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.

Timeline

Start
2007-06
Primary completion
2015-06
Completion
2015-07

Outcome

Missed primary endpoint

registry analysis (superiority test); Control Arm vs Experimental Arm; p = 0.73; Hazard Ratio (HR) 0.946 (95% CI 0.689 to 1.298); Log Rank NCT00478699 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified 75 mg/m2 —
Subject Docetaxel Small molecule 75 mg/m2 —
Subject Gemcitabine Small molecule 1250 mg/m2 —