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Head-Neck

Phase 3 randomized trial of concomitant radiation, cisplatin, and tirapazamine (SR259075) versus concomitant radiation and cisplatin in patients with advanced head and neck cancer

Unique Data Set IDHeadNe_SanofiU_2002_129
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients861Comparator (Control) Arm Enrolled Patients431RandomizationYesClinicalTrial.gov IDNCT00094081ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/study/NCT00094081?term=SR259075+EFC4690&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodSingle-BlindedType(s) of dataOnly comparator arm dataIntervention TypeChemotherapy, RadiationData Set TypeADS

Clinical Trial Title

Phase 3 randomized trial of concomitant radiation, cisplatin, and tirapazamine (SR259075) versus concomitant radiation and cisplatin in patients with advanced head and neck cancer

Trial Summary and Conditions

A Phase 3, multicenter, international, randomized open-label, 2-arm trial comparing 2 chemotherapy regimens: cisplatin (control arm) versus cisplatin and tirapazamine (experimental arm), each regimen used with concomitant radiation in the treatment of advanced head and neck cancer. Subjects with previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx, Stage III or Stage IV (excluding T1N1, T2N1, and metastatic disease). Subjects must have ambulatory Eastern Cooperative Oncology Group (ECOG) performance status =< 2 and adequate renal, hepatic, and hematologic function.

Data Summary

Datasets contain de-identified subjects from the comparator arm. Demographic, baseline information, safety, efficacy datasets, medication, and dosing datasets were included amongst others.

Study Objectives

Primary: Compare overall survival. Secondary: 1) Failure-free survival (FFS). 2) time to locoregional failure. 3) initial response rates at 2 months after completion of chemoradiation therapy. 4) Toxicity and safety. Also patterns of failure, cumulative incidence of unacceptable locoregional treatment outcome, change of quality of life (QoL) from baseline, Final complete response (CR) rate, and biologic correlates of outcome (eg, hypoxia, tumor markers) will also be analyzed.

Outcome Measures

Overall survival is the number of months from randomization until death from any cause. Failure-free survival is the number of months from randomization until the earliest of locoregional failure, development of distant metastasis, or death.

Available Downloads:

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

PROTOCOL: sanofi_SR259075_EFC4690_protocol_Redacted.pdf

CRF: sanofi_SR259075_EFC4690_crf_Redacted.pdf

DATA DICTIONARY: sanofi_SR259075_EFC4690_data_definition.xls

DATA (COMPARATOR ARM): sanofi_sr259075_EFC4690_datasets_readme.zip