- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00261703
Docetaxel in Head and Neck Cancer
May 10, 2012 updated by: Sanofi
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).
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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
439
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
(Docetaxel + Cisplatin + 5-FU) + Cisplatin + Radiotherapy
|
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)
|
Experimental: 2
(Cisplatin + 5-FU) + Cisplatin + Radiotherapy
|
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)
|
Experimental: 3
Cisplatin + Radiotherapy
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
16 weeks
|
Phase III: Surveillance with no progression after two years.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: JOSÉ Mª TABOADA, Sanofi
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2002
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
December 2, 2005
First Submitted That Met QC Criteria
December 2, 2005
First Posted (Estimate)
December 5, 2005
Study Record Updates
Last Update Posted (Estimate)
May 11, 2012
Last Update Submitted That Met QC Criteria
May 10, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Head and Neck Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
- Cisplatin
- Fluorouracil
Other Study ID Numbers
- XRP6976F_2503
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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