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A Randomized, Open Label Multi-Center Study of Single Agent Larotaxel (XRP9881) Compared to Continuous Administration of 5-FU For The Treatment of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing RegimenUnique Dataset IDPancrea_Sanofi_2006_109
Clinical Trial Title
A Randomized, Open Label Multi-Center Study of Single Agent Larotaxel (XRP9881) Compared to Continuous Administration of 5-FU For The Treatment of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen
Trial Summary and Conditions
Previous results suggest that larotaxel may provide an additional therapeutic option for patients with pancreatic carcinoma maintaining a good performance status while progressing under gemcitabine-containing chemotherapy. It is therefore proposed to investigate larotaxel in pancreas cancer failing after a gemcitabine-based therapy as a treatment option for APC.
These datasets are analysis datasets that bear some resemblance to CDISC ADaM standards. These datasets has been subsetted to include data for only the comparator arm of this clinical trial.
Primary end-point: - Overall survival will be assessed from the date of randomization to death. Main Secondary End-points: - Progression free survival will be evaluated from date of randomization to tumor progression or death. - Objective responses (CR and PR) as assessed by investigators according to RECIST criteria - Safety profile of the study treatment in terms of AEs/ SAEs and laboratory parameters. - Clinical Benefit will be based on the measurement of tumor related symptoms including a composite score of pain severity assessed by Visual Analog Scale (VAS), analgesic consumption as morphine equivalents, ECOG PS and weight loss of greater than or equal to 5% from baseline. The Clinical Benefit will be assessed by time to symptom worsening (TTSW).
Outcomes documented in the protocol
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DATA DICTIONARY: Read me first-info data definition files XRP9881 EFC6596.docx
DATA (COMPARATOR ARM): SAS datasets.zip
Other: data definition files.zip