Docetaxel in Head and Neck Cancer

Sanofi439 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

439

Conditions

Head and Neck Neoplasms

Interventions

Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapyDRUG

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-fluorouracil (5-FU), radiotherapyDRUG

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 + radiotherapyOTHER

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Sanofi-Aventis

Porto Salvo, Portugal

Sanofi-Aventis

Barcelona, Spain

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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