NCT00271323

Safety Study of Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in NSCLC Patients

A Two Arm Phase II Study Assessing Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-multiple cN2 or IIIB)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

* Primary : To determine the safety profile of each treatment group. * Secondary : To determine efficacy in term of overall response, disease free survival and survival at 1 and 2 years.

Conditions

• Non-Small-Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	docetaxel and cisplatin	Docetaxel (75 mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemo-radiotherapy with docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy.
RADIATION	radiotherapy	Docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy followed by docetaxel (75 mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles.

Timeline

• Start date: 2005-05-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2005-12-30
• Last updated: 2009-12-23

Locations

1 site across 1 country: France