Docetaxel in Head and Neck Cancer

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

439

Participants

Timeline

Start Date

December 31, 2002

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Head and Neck Neoplasms
Interventions
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)

Trial Locations (2)

Unknown

Sanofi-Aventis, Porto Salvo

Sanofi-Aventis, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY