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Type(s) of Cancer
Head and Neck
Study Phase
Phase 2BPhase 3
Study Completion Date
June 2003
NCT00401323Uploaded 06-22-2015
Available for Download
PDS UID: HeadNe_SanofiU_1998_142
A Randomized Phase II-III Multicenter Trial of Docetaxel Plus Cisplatin and Docetaxel Plus 5-FU Versus Cisplatin Plus 5-FU in 1st Line Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.
Provider Information
Provider Data DescriptionPrimary: To compare time to progression (TTP) after treatment with Taxotere plus cisplatin (TP treatment group) versus cisplatin plus 5-FU (PF treatment group). Secondary: To compare overall survival (OS), the main secondary endpoint, after treatment with Taxotere plus cisplatin (TP treatment group) versus cisplatin plus 5-FU (PF treatment group). The following endpoints were also compared between the 2 treatment groups: overall response rate, duration of response, time to treatment failure (TTF), and toxicity.
SponsorSanofi US Services Inc.
Data ProviderSanofi
Partial set or SubsetOriginal Data
Patients in dataset568
# of Patients Control282
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/fjhs-m535
CDISC Standardraw data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.
ConditionsHead and Neck Neoplasms
Neoplasm Recurrence, Local
Neoplasm Metastasis
Intervention TypeDrug: docetaxel (XRP6976)
Drug: cisplatin
Drug: 5-fluorouracil (5-FU)
Drug(s)Drug: docetaxel (XRP6976)
Drug: cisplatin
Drug: 5-fluorouracil (5-FU)
Total Enrolled568
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms Interventiondocetaxel plus cisplatin - Experimental
cisplatin plus 5-FU - Active Comparator
docetaxel plus 5-FU - Experimental
Secondary IDXRP6976G-322
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
France
Germany
Greece
Guadeloupe
Hungary
Israel
Italy
Russian Federation
Réunion
South Africa
Spain
Switzerland
Uruguay
Age Range18 Years to 75 Years (Adult, Older Adult)
Files:
PROTOCOLsanofi_xrp6976_efc6051_protocol_and_amendments_redacted.pdf
CRFsanofi_xrp6976_efc6051_CRF_redacted.pdf
DATA DICTIONARYXRP6976_EFC6051_datasphere.xls
DATA (COMPARATOR ARM)sanofi_xrp6976_efc6051_datasets_and_readme.zip
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