NCT00432315

Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Multicenter Phase II Study Evaluating Docetaxel and CDDP as Induction Regimen Prior to Surgery or Radiochemotherapy With Docetaxel, Followed by Adjuvant Docetaxel Therapy in Chemonaive Patients With NSCLC Stage II, IIIa and IIIb

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: • To assess the response rate to induction therapy with docetaxel/CDDP. Secondary objectives: To assess * Resectability after induction therapy * Time to progression * Overall survival * Safety profile * Quality of Life

Conditions

• Carcinoma, Squamous Cell

Interventions

Type	Name	Description
DRUG	Docetaxel + CDDP	* 3 cycles chemotherapy : docetaxel + CDDP * Surgery (if no histologically proven R0-resection could be achieved,additional adjuvant radiotherapy should be considered) * 3 cycles adjuvant chemotherapy docetaxel
DRUG	docetaxel + CDDP	* 3 cycles chemotherapy: docetaxel + CDDP * Radiochemotherapy * 3 cycles adjuvant chemotherapy docetaxel

Timeline

• Start date: 2001-05-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2007-02-07
• Last updated: 2010-09-14

Locations

1 site across 1 country: Austria