Docetaxel in Head and Neck Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

439 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Head and Neck Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

(Docetaxel + Cisplatin + 5-FU) + Cisplatin + Radiotherapy

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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)

2

(Cisplatin + 5-FU) + Cisplatin + Radiotherapy

Group Type EXPERIMENTAL

Cisplatin, 5-fluorouracil (5-FU), radiotherapy

Intervention Type DRUG

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)

3

Cisplatin + Radiotherapy

Group Type EXPERIMENTAL

Cisplatin + radiotherapy

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type 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)

Intervention Type DRUG

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)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No