NCT00261703

Docetaxel in Head and Neck Cancer

Randomized Phase III Trial Comparing Induction Chemotherapy With Cisplatin/5-fluorouracil (PF) or Docetaxel/Cisplatin/5-fluorouracil (TPF) Plus Chemoradiotherapy (CRT) Versus CRT Alone as First-line Treatment or Unresectable Locally Advanced Head and Neck Cancer (LAHNC).

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 439 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: * Phase II: To determine the best treatment scheme (TPF vs. PF). * Phase III: To compare the time to progression and the treatment failure at the 3 arms. Secondary objectives: * To evaluate the safety at the 3 arms. * To compare the progression , overall survival and locoregional control at the 3 arms.

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy	Docetaxel 75 mg/m2, Day 1 of the cycle + Cisplatin 75 mg/m2 Day 1 + 5-FU 750 mg/m2/day in 24-h continuous infusion for 5 days. 3 cycles will be administered, every 21 days, before the local-regional treatment (same as control group)
DRUG	Cisplatin, 5-fluorouracil (5-FU), radiotherapy	Cisplatin 100 mg/m2 Day 1, 5-FU 1000 mg/m2/day in 24-h continuous infusion for 5 consecutive days. 3 cycles will be administered every 21 days, before the local-regional treatment (same as control group)
OTHER	Cisplatin + radiotherapy	Cisplatin 100 mg/m2 on days 1, 22 and 43 simultaneously with radiotherapy (2 Gy x 1/day, 5 days per week for 7 weeks-tumor- and 2 Gy x 1/day, 5 days per week for 6 weeks- lymph nodes)

Timeline

• Start date: 2002-12-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2005-12-05
• Last updated: 2012-05-11

Locations

2 sites across 2 countries: Portugal, Spain