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Gastric

Open label, randomized multicenter Phase II/III study of Docetaxel in combination with Cisplatin or Docetaxel in combination with 5-Fluorouracil and Cisplatin compared to the combination of Cisplatin and 5-Fluorouracil in patients with metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease.

Unique Data Set IDGastric_SanofiU_1999_143
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients445Comparator (Control) Arm Enrolled Patients218RandomizationYesClinicalTrial.gov IDNCT00290966ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00290966?term=xrp6976&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyData Set TypeOther

Clinical Trial Title

Open label, randomized multicenter Phase II/III study of Docetaxel in combination with Cisplatin or Docetaxel in combination with 5-Fluorouracil and Cisplatin compared to the combination of Cisplatin and 5-Fluorouracil in patients with metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease.

Trial Summary and Conditions

This is a prospective, multicentre, multinational, non blinded, randomized phase 2/3 study. The Phase Ill part of the study (for which this data is for) will compare the survival between the selected investigational arm and the control arm. A closed testing procedure will be used to combine a test of superiority of the investigational arm relative to the control and a test of equivalence between the investigational arm and the control with respect to survival. The study population is patients with metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. After having properly checked all eligibility criteria, obtained patient informed consent and baseline quality of life questionnaire filled in, patients will be randomized in the study. A patient who has been treated prior to registration will not be accepted for the study.

Data Summary

Datasets Demographic, baseline information, safety, efficacy datasets, medication, quality of life, and dosing datasets were included amongst others. Source data is raw and derived data.

Study Objectives

To detect a statistically significant increase in time to progression (TTP) of disease for the test group (Taxotere combined with cisplatin and 5-fluorouracil [TCF]) relative to the control group (cisplatin combined with 5-fluorouracil [CF]). To detect a statistically significant increase in overall survival (OS) for the test group relative to the control group.To compare response rate (RR), time to treatment failure (TTF), duration of responses, safety profiles, quality of life (QOL), and disease-related symptoms.

Outcome Measures

Subjects were assessed for tumor response and progression (defined according to WHO criteria) every 8 plus or minus 1 weeks. All tumor assessments were to be reviewed by an External Response Review Committee (ERRC). The primary efficacy endpoint was TTP, using all TTP events in the database (end of study analysis). The main secondary efficacy endpoint was OS. Other secondary efficacy endpoints were RR, duration of response, and TTF. The primary (TTP) and secondary (OS, RR, duration of response, TTF) efficacy variables were evaluated in the full analysis population (FAP) and except for OS, in the per protocol population (PPP). Duration of response was calculated for responders.

Available Downloads:

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

PROTOCOL: SANOFI_XRP6976_TAX325_Clinical_Study_Protocol_Redacted.pdf

CRF: SANOFI_XRP6976_TAX325_CRF.pdf

DATA DICTIONARY: sanofi_XRP6976_TAX325_data_definition.xls

DATA (COMPARATOR ARM): sanofi_xrp6976_tax325_datasets_and_readme.zip