NCT00261703CompletedPhase 2
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).
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 439
- Locations
- 1
- Primary Endpoint
- 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).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Experimental
(Docetaxel + Cisplatin + 5-FU) + Cisplatin + Radiotherapy
Intervention: Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy (Drug)
2
Experimental
(Cisplatin + 5-FU) + Cisplatin + Radiotherapy
Intervention: Cisplatin, 5-fluorouracil (5-FU), radiotherapy (Drug)
3
Experimental
Cisplatin + Radiotherapy
Intervention: Cisplatin + radiotherapy (Other)
Outcomes
Primary Outcomes
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).
Time Frame: 16 weeks
Phase III: Surveillance with no progression after two years.
Time Frame: 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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