Clinical trial NCT00261703: Docetaxel in Head and Neck Cancer
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Head and Neck Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-05
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: 16 weeks
measure: Phase III: Surveillance with no progression after two years.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Salvo
country: Portugal
facility: Sanofi-Aventis
city: Barcelona
country: Spain
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: JOSÉ Mª TABOADA
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.