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Phase 3 randomized trial of concomitant radiation, cisplatin, and tirapazamine (SR259075) versus concomitant radiation and cisplatin in patients with advanced head and neck cancerUnique Data Set IDHeadNe_SanofiU_2002_129
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.
Datasets contain de-identified subjects from the comparator arm. Demographic, baseline information, safety, efficacy datasets, medication, and dosing datasets were included amongst others.
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.
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.
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DATA DICTIONARY: sanofi_SR259075_EFC4690_data_definition.xls
DATA (COMPARATOR ARM): sanofi_sr259075_EFC4690_datasets_readme.zip