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A multicenter phase III randomized trial comparing TAXOTERE administered either weekly or every three weeks in combination with prednisone versus mitoxantrone in combination with prednisone for metastatic hormone-refractory prostate cancerUnique Dataset IDProstat_Sanofi_2000_80ClinicalTrial.gov IDSTUDY_TAX-327
Clinical Trial Title
A multicenter phase III randomized trial comparing TAXOTERE administered either weekly or every three weeks in combination with prednisone versus mitoxantrone in combination with prednisone for metastatic hormone-refractory prostate cancer
Trial Summary and Conditions
This dataset was included in the Prostate Cancer Tumor Growth data cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer. To view the consolidated Prostate Cancer Tumor Growth data, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/167
Promising results have been reported with Docetaxel in Hormone Refractory Prostate Cancer (HRPC) in terms of i) objective response in measurable lesions, ii) palliative response (pain relief, analgesic intake, symptom control), iii) PSA decline of more than 50%. These results which compared favorably with data from other cytotoxic combinations reported thus far should now be confirmed and further prospectively investigated through a multicenter randomized phase III trial.
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 OBJECTIVE To compare overall survival (OS) after mitoxantrone and prednisone (arm A) and docetaxel and prednisone (with arm B: docetaxel Every 3 weeks and with arm C: weekly docetaxel) in subjects with metastatic hormone-refractory prostate cancer. SECONDARY OBJECTIVES - Pain Progression-Free Survival - PSA Progression-Free Survival - Tumor Progression-Free Survival - Disease Progression-Free Survival - Pain improvement (incidence and duration) - PSA response (incidence and duration) - Quality of life - Response rate in subjects with measurable disease - Safety - Pharmacokinetics of Taxotere in combination with prednisone An independent socio-economic evaluation was to be conducted in parallel with the clinical study.
Outcomes documented in the protocol
To gain access to the data and analytic tools click here.
PROTOCOL: Sanofi Study Protocol Taxotere.pdf
CRF: Sanofi CRF Taxotere.pdf
DATA DICTIONARY: Additions and modifications made to datasets 14JUN2018.docx
DATA (COMPARATOR ARM): Sanofi Data Descriptors Taxotere.doc
DATA (COMPARATOR ARM): Sanofi Data Taxotere.zip