drugset / Trial / NCT03371550

A Phase II Trial of Cisplatin-Docetaxel Induction Plus Concurrent 3-D Conformal Radiotherapy and Weekly Chemotherapy

NCT03371550 ↗

Phase 2 Completed 44 enrolled Centre Antoine Lacassagne
NaSingle-groupOpen-labelTreatment

Summary

Concurrent chemoradiotherapy (CHRT) is the standard of care for unresectable locally advanced stage III non-small cell lung cancer. However, the optimal combination remains unclear. The aim of this study is to evaluate the efficacy of 2 induction chemotherapy cycles (days 1 and 22) with docetaxel 75 mg/m2 and cisplatin 75 mg/m2 followed by concurrent chemotherapy (weekly docetaxel-cisplatin, 20 mg/m2) and 3-D conformal radiotherapy for 6 weeks (66 Gy/5 fractions per week/2 Gy per fraction). ). The primary endpoint is the response rate. Secondary objectives are toxicity, time to progression, and overall survival.

Timeline

Start
2004-08-05
Primary completion
2010-10-31
Completion
2011-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 20 mg/m2 —
Subject Docetaxel Small molecule 20 mg/m2 —