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Head-Neck

A randomized phase II-III multicenter trial of docetaxel (Taxotere) plus cisplatin and docetaxel plus 5-fluorouracil (5-FU) versus cisplatin plus 5-fluorouracil to improve time to progression and overall survival in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

Unique Data Set IDHeadNe_SanofiU_1998_142
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients568Comparator (Control) Arm Enrolled Patients282RandomizationYesClinicalTrial.gov IDNCT00401323ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00401323?term=EFC6051&rank=1
Study PhaseClinical Study Phase IIB, Clinical Study Phase IIIBlinding MethodOtherType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyData Set TypeOther

Clinical Trial Title

A randomized phase II-III multicenter trial of docetaxel (Taxotere) plus cisplatin and docetaxel plus 5-fluorouracil (5-FU) versus cisplatin plus 5-fluorouracil to improve time to progression and overall survival in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

Trial Summary and Conditions

This was a multicenter, non-blinded, randomized, stratified phase II-III study. The phase II part of the study was planned to estimate overall response rate and to evaluate toxicity in 3 treatment groups-Taxotere plus cisplatin (TP), Taxotere plus 5-FU (TF), and cisplatin plus 5-FU (PF)-administered as first-line treatment for patients with recurrent and/or metastatic SCCHN. Additionally, the phase II part of the study was to determine which regimen(s) to continue in the phase III part of the study. The phase III part of the study compared 2 chemotherapy regimens as first-line treatment for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Patients were randomized (1:1) to receive either TP or PF. Patients were stratified at inclusion according to country and extent of disease. Patients were to receive 6 cycles of chemotherapy at 3-week intervals unless progression of disease (PD) or unacceptable toxicity occurred, or the patient refused treatment. Further treatment was indicated for patients with objective response or stable disease. All patients were to be followed until death.

Data Summary

Datasets contain the 282 de-identified subjects assigned to the control arm. Demographic, baseline information, safety, efficacy datasets, medication, and dosing datasets were included amongst others. Source data is raw data.

Study Objectives

Primary: 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.

Outcome Measures

Time to progression, overall survival, overall response, duration of response, time to treatment failure and toxicity.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: sanofi_xrp6976_efc6051_protocol_and_amendments_redacted.pdf

CRF: sanofi_xrp6976_efc6051_CRF_redacted.pdf

DATA DICTIONARY: XRP6976_EFC6051_datasphere.xls

DATA (COMPARATOR ARM): sanofi_xrp6976_efc6051_datasets_and_readme.zip