drugset / Trial / NCT01038661

Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy

NCT01038661 ↗

Phase 3 Completed 375 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

The Primary Objective is to evaluate the progression-free survival (PFS). The secondary objectives are: * To compare the disease control rates of different doses of Docetaxel+Cisplatin as first-line treatment according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria; * To evaluate the overall response rate (ORR); * To evaluate the time to disease progression (TTP); * To evaluate the overall survival (OS); * To evaluate the toxicity.

Timeline

Start
2009-11
Primary completion
2012-08
Completion
2012-08

Outcome

Met primary endpoint

paper DCM significantly prolonged PFS compared to BSC (HR =0.57, median PFS =5.8 vs. 3.0 months, P=0.002). PMID 33708965 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Docetaxel Small molecule 60 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous

Indications