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Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin Un-fit Advanced Urothelial Carcinoma: Randomized Phase II Study
Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma. But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice. Recently reported phase II/III trial of EORTC 30986 comparing gemcitabine/carboplatin (GCb) with MCAVI (Methotrexate, Carboplatin, Vinblastine) suggested that GCb be the preferred regimen over MCAVI based on the response rates, adverse events, and severe acute toxicities. But the grade 3 or worse toxicities associated with GCb are not infrequent and need more effective and more tolerable regimens. GemOx has been reported to be effective and have very favorable toxicity profiles.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Keimyeong University Dongsan Medical Center
Daegu, South Korea
Chungnam University Hospital
Daejeon, South Korea
Korea University Anam Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Chung Ang University Hospital
Seoul, South Korea
Start Date
October 1, 2010
Primary Completion Date
June 1, 2015
Last Updated
September 25, 2014
80
ESTIMATED participants
GCb
DRUG
GemOx
DRUG
Lead Sponsor
Asan Medical Center
NCT05929235
NCT07048457
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