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Docetaxel in Head and Neck Cancer

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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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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