Docetaxel in Head and Neck Cancer

Sanofi

Status and phase: Completed; Phase 3; Phase 2

Conditions: Head and Neck Neoplasms

Treatments: Drug: Cisplatin, 5-fluorouracil (5-FU), radiotherapy; Other: Cisplatin + radiotherapy; Drug: Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00261703

XRP6976F_2503

Details and patient eligibility

About

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.

Enrollment: 439 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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439 participants in 3 patient groups

1

Experimental group

Description:

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

Treatment:

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

2

Experimental group

Description:

(Cisplatin + 5-FU) + Cisplatin + Radiotherapy

Treatment:

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

3

Experimental group

Description:

Cisplatin + Radiotherapy

Treatment:

Other: Cisplatin + radiotherapy