Clinical trial · Interventional
Docetaxel in Head and Neck Cancer
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).
NCT00261703CI-TRIAL-00006881completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin, 5-fluorouracil (5-FU), radiotherapy | Drug | — | UNRESOLVED |
| Cisplatin + radiotherapy | Other | — | UNRESOLVED |
| Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- description
- (Docetaxel + Cisplatin + 5-FU) + Cisplatin + Radiotherapy
- interventionNames
- Drug: Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy
- type
- EXPERIMENTAL
- label
- 2
- description
- (Cisplatin + 5-FU) + Cisplatin + Radiotherapy
- interventionNames
- Drug: Cisplatin, 5-fluorouracil (5-FU), radiotherapy
- type
- EXPERIMENTAL
- label
- 3
- description
- Cisplatin + Radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDHitt 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
- DERIVEDHitt 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