drugset / Trial / NCT00174772

Pulmonart: Docetaxel - Non-Small Cell Lung Cancer (NSCLC)

NCT00174772 ↗

Phase 2 Completed 72 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: * To evaluate the toxicity/safety profile of docetaxel/cisplatin induction therapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by consolidation docetaxel/cisplatin in patients with locally advanced unresectable NSCLC (stage IIIA- multiple cN2 or IIIB). Secondary Objective: * To estimate efficacy parameters in overall response rate, progression free survival and 1 year survival for each of the two above mentioned arms.

Timeline

Start
2004-03
Primary completion
2009-02
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 20 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 40 mg/m2 Intravenous
Subject Docetaxel Small molecule 20 mg/m2 Intravenous
Subject Docetaxel Small molecule 40 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous

Indications