Docetaxel in Head and Neck Cancer

Phase 2

Completed

• Conditions: Head and Neck Neoplasms
• Interventions: Drug: Cisplatin, 5-fluorouracil (5-FU), radiotherapy; Other: Cisplatin + radiotherapy; Drug: Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy

• Registration Number: NCT00261703
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2005-12-02
• Study First Submitted QC: 2005-12-02
• Study First Posted: 2005-12-05
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 439

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Cisplatin, 5-fluorouracil (5-FU), radiotherapy	(Cisplatin + 5-FU) + Cisplatin + Radiotherapy
3	Cisplatin + radiotherapy	Cisplatin + Radiotherapy
1	Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy	(Docetaxel + Cisplatin + 5-FU) + Cisplatin + Radiotherapy

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis; 🇪🇸 Barcelona, Spain