Docetaxel in Head and Neck Cancer

NCT00261703 | Completed Phase 2

• 1 other identifier: XRP6976F_2503
• Study Type: interventional
• Target: 439
• Locations: 2 countries
• Sites: 2

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.

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

1

EXPERIMENTAL

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

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

2

EXPERIMENTAL

(Cisplatin + 5-FU) + Cisplatin + Radiotherapy

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

3

EXPERIMENTAL

Cisplatin + Radiotherapy

Other: Cisplatin + radiotherapy

Interventions

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

1

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

2

Cisplatin + radiotherapy 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)

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Sanofi-Aventis

Porto Salvo, Portugal

Location

Sanofi-Aventis

Barcelona, Spain

Location

Related Publications (2)

• Hitt R, Iglesias L, Lopez-Pousa A, Berrocal-Jaime A, Grau JJ, Garcia-Giron C, Martinez-Trufero J, Guix M, Lambea-Sorrosal J, Del Barco-Morillo E, Leon-Vintro X, Cunquero-Tomas AJ, Baste N, Ocana A, Cruz-Hernandez JJ; the Spanish Head and Neck Cancer Cooperative Group (TTCC). Long-term outcomes of induction chemotherapy followed by chemoradiotherapy vs chemoradiotherapy alone as treatment of unresectable head and neck cancer: follow-up of the Spanish Head and Neck Cancer Group (TTCC) 2503 Trial. Clin Transl Oncol. 2021 Apr;23(4):764-772. doi: 10.1007/s12094-020-02467-8. Epub 2020 Aug 14.

  PMID: 32797376 DERIVED

• Hitt R, Grau JJ, Lopez-Pousa A, Berrocal A, Garcia-Giron C, Irigoyen A, Sastre J, Martinez-Trufero J, Brandariz Castelo JA, Verger E, Cruz-Hernandez JJ; Spanish Head and Neck Cancer Cooperative Group (TTCC). A randomized phase III trial comparing induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as treatment of unresectable head and neck cancer. Ann Oncol. 2014 Jan;25(1):216-25. doi: 10.1093/annonc/mdt461. Epub 2013 Nov 19.

  PMID: 24256848 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Docetaxel; Cisplatin; Fluorouracil; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• JOSÉ Mª TABOADA

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2005
• First Posted: December 5, 2005
• Study Start: December 1, 2002
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 11, 2012

Record last verified: 2012-05

Locations

ES (1); PT (1)