Docetaxel in Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT00261703|
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : May 11, 2012
- 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.
- To evaluate the safety at the 3 arms.
- To compare the progression , overall survival and locoregional control at the 3 arms.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms||Drug: Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy Drug: Cisplatin, 5-fluorouracil (5-FU), radiotherapy Other: Cisplatin + radiotherapy||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||439 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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).|
|Study Start Date :||December 2002|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
(Docetaxel + Cisplatin + 5-FU) + Cisplatin + Radiotherapy
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)
(Cisplatin + 5-FU) + Cisplatin + Radiotherapy
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)
Cisplatin + Radiotherapy
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)
- Phase II: Clinical objective response rate, at the end of inducted chemotherapy (groups A and B) and at the end of combined treatment (groups A, B and C). [ Time Frame: 16 weeks ]
- Phase III: Surveillance with no progression after two years. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261703
|Porto Salvo, Portugal|
|Study Director:||JOSÉ Mª TABOADA||Sanofi|