Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma
NCT ID: NCT01487915
Last Updated: 2014-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2010-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GCb
Gemcitabine plus Carboplatin
GCb
Gemcitabine 1000 mg/㎡ D1, D8 plus Carboplatin AUC=4.5 D1 every 3 weeks
GemOx
Gemcitabine plus Oxaliplatin
GemOx
Gemcitabine 1000 mg/㎡ D1 plus Oxaliplatin 100 mg/㎡ D1 every 2 weeks
Interventions
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GCb
Gemcitabine 1000 mg/㎡ D1, D8 plus Carboplatin AUC=4.5 D1 every 3 weeks
GemOx
Gemcitabine 1000 mg/㎡ D1 plus Oxaliplatin 100 mg/㎡ D1 every 2 weeks
Eligibility Criteria
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Inclusion Criteria
* Locally advanced or metastatic disease
* Measurable disease according to RECIST v.1.1
* ECOG PS 0-2
* Cisplatin-unfit condition (any of the followings: NYHA functional class 3, creatinine clearance 30-60 ml/min, and ECOG PS=2)
* Adequate organ function
* Chemotherapy-naive
Exclusion Criteria
* CNS metastases
* Peripheral neuropathy grade 2 or worse
* Serious medical or surgical conditions
18 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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JLee
Associate professor
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Hong Seok Song, MD, PhD.
Role: primary
Jin Young Kim, MD
Role: backup
Hyo Jin Lee, MD, PhD.
Role: primary
Kyeong Hwa Park, MD, PhD
Role: primary
Hee Joon Kim, MD
Role: primary
References
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Park I, Kim BS, Lim HY, Kim HJ, Lee HJ, Choi YJ, Park KH, Lee KH, Yoon S, Hong B, Hong JH, Ahn H, Lee JL. Gemcitabine plus carboplatin versus gemcitabine plus oxaliplatin in cisplatin-unfit patients with advanced urothelial carcinoma: a randomised phase II study (COACH, KCSG GU10-16). Eur J Cancer. 2020 Mar;127:183-190. doi: 10.1016/j.ejca.2019.08.034. Epub 2019 Oct 24.
Other Identifiers
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KCSG-GU10-16
Identifier Type: OTHER
Identifier Source: secondary_id
UOSG-AMC-1001
Identifier Type: -
Identifier Source: org_study_id
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