Head and Neck Neoplasms
Conditions
Brief 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.
Interventions
DRUGDocetaxel, 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)
DRUGCisplatin, 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)
OTHERCisplatin + 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)
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Head and Neck cancer locally advanced (oral cavity, oropharynx, hypopharynx or larynx) but without evident metastasis. * Inoperable tumor after revision by a multidisciplinary oncology team. * Proved epidermoid carcinoma. * ECOG = 0-1 * Good hematologic function (i.e, hemoglobin \> 10 g/dl, ...) * Good hepatologic function * Good renal function
Exclusion criteria
* Pregnant or breast-feeding women. Potential child-bearing women should use an effective conceptive method and should have a negative pregnancy test at least the week before entering the study. * Nasopharynx, nasal cavity and paranasal sinusitis will be excluded * Previous chemotherapeutic or radiotherapeutic treatment for this disease. * Previous or current neoplasms in other locations, except in situ cervicouterine cancer properly treated or basal cell or squamous cell carcinoma * Symptomatic peripheral neuropathy * Other clinical severe diseases * Concomitant treatment with corticoids within 6 months prior to inclusion. * Concomitant treatment with any other neoplastic therapy * Previous treatment for current disease. * Loss of weight greater than 10% within the last 3 months. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | 16 weeks |
| Phase III: Surveillance with no progression after two years. | 2 years |
Countries
Portugal, Spain
Outcome results
None listed