Docetaxel in Head and Neck Cancer

Head and Neck Neoplasms Clinical Trial

Official title:

Randomized Phase III Trial Comparing Induction Chemotherapy With Cisplatin/5-fluorouracil (PF) or Docetaxel/Cisplatin/5-fluorouracil (TPF) Plus Chemoradiotherapy (CRT) Versus CRT Alone as First-line Treatment or Unresectable Locally Advanced Head and Neck Cancer (LAHNC).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261703
• Other study ID #: XRP6976F_2503
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 2, 2005
• Last updated: May 10, 2012
• Start date: December 2002
• Est. completion date: July 2010

Study information

• Verified date: May 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Drug:
• 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)
• 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)

Other:
• 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)

Locations

Country	Name	City	State
Portugal	Sanofi-Aventis	Porto Salvo
Spain	Sanofi-Aventis	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Phase III: Surveillance with no progression after two years.		2 years	No