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Type(s) of Cancer
Bladder
Study Phase
Phase 2
Study Completion Date
2020-02
NCT02177695Uploaded 08-24-2024
Access via NCI by Request
PDS UID: nci-data-552
A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) With Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer
Provider Information
Provider Data DescriptionThis dataset contains participant-level data (one row per participant), including treatment, demographic, and baseline information. It also contains assessment data, including data needed for time-to-event analyses. The unique participant identifier in this dataset is the same identifier used in the S1314 molecular dataset found in the Gene Expression Omnibus database (record ID: GSE244266).
SponsorSWOG Cancer Research Network
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThe primary focus of this study is to see if looking at tumor biomarkers using a program called coexpression extrapolation or "COXEN" may predict a patient's response to chemotherapy before surgery.
ConditionsBladder Cancer
Intervention TypeDrug: Gemcitabine
Drug: Cisplatin
Drug: Methotrexate
Drug: Vinblastine
Drug: Doxorubicin
Drug: Filgrastim
Drug(s)Drug: Gemcitabine
Drug: Cisplatin
Drug: Methotrexate
Drug: Vinblastine
Drug: Doxorubicin
Drug: Filgrastim
Total Enrolled237
RandomizationRandomized
Blinding MethodNone
Arms InterventionGemcitabine & Cisplatin - Experimental
Dose Dense MVAC - Experimental
Secondary IDS1314
PubMed (PMID)33568346
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT02177695-D1
Data DictionaryNCT02177695-D1-Data-Dictionary.pdf
DATANCT02177695-D1-Dataset.csv
OTHERREADME.pdf
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