Back to resultsDocetaxel in Head and Neck Cancer
Primary Purpose
Head and Neck Neoplasms
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy
Cisplatin, 5-fluorouracil (5-FU), radiotherapy
Cisplatin + radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms
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.
Sites / Locations
- Sanofi-Aventis
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
(Docetaxel + Cisplatin + 5-FU) + Cisplatin + Radiotherapy
(Cisplatin + 5-FU) + Cisplatin + Radiotherapy
Cisplatin + Radiotherapy
Outcomes
Primary Outcome Measures
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).
Phase III: Surveillance with no progression after two years.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00261703
Brief Title
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
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
439 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
(Docetaxel + Cisplatin + 5-FU) + Cisplatin + Radiotherapy
Arm Title
2
Arm Type
Experimental
Arm Description
(Cisplatin + 5-FU) + Cisplatin + Radiotherapy
Arm Title
3
Arm Type
Experimental
Arm Description
Cisplatin + Radiotherapy
Intervention Type
Drug
Intervention Name(s)
Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Cisplatin, 5-fluorouracil (5-FU), radiotherapy
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Cisplatin + radiotherapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
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
Title
Phase III: Surveillance with no progression after two years.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOSÉ Mª TABOADA
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Porto Salvo
Country
Portugal
Facility Name
Sanofi-Aventis
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
32797376
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.
Results Reference
derived
PubMed Identifier
24256848
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.
Results Reference
derived
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Docetaxel in Head and Neck Cancer
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