Docetaxel in Head and Neck Cancer
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|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|
|Actual Primary Completion Date :||July 2010|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261703
|Porto Salvo, Portugal|
|Study Director:||JOSÉ Mª TABOADA||Sanofi|