Spots Global Cancer Trial Database for CAPOXIRI+Bevacizumab vs. FOLFOXIRI+Bevacizumab for mCRC
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Trial Identification
Brief Title: CAPOXIRI+Bevacizumab vs. FOLFOXIRI+Bevacizumab for mCRC
Official Title: Quadruplet 1st Line Treatment of CAPOXIRI Plus Bevacizumab Versus FOLFOXIRI Plus Bevacizumab for mCRC, Multicenter Randomised Phase II Study (QUATTRO-II)
Study ID: NCT04097444
Conditions
Study Description
Brief Summary: The objective is to compare the efficacy and safety of CAPOXIRI+BEV therapy versus FOLFOXIRI+BEV therapy as first-line therapy in patients with metastatic colorectal cancer (mCRC).
Detailed Description: QUATTRO-II is an open-label, multicenter, randomised, phase II study to investigate the efficacy and safety of CAPOXIRI+BEV versus FOLFOXIRI+BEV in 1st line mCRC. This study is composed two steps because of confirming of recommended dose (RD) for CAPOXIRI+BEV regimen. 1. Dose finding step (Step1): CAPOXIRI+BEV doses findings were planned by 3+3 cohort design, register up to maximum of 12 cases. 2. Randomised step (Step2): After confirmation of RD regarding CAPOXIRI+BEV, we will move to Step2 to compare the efficacy and safety between FOLFOXIRI+BEV and CAPOXIRI+BEV, register up to 65 cases.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ac Medical Inc., Chuo Ku, Tokyo, Japan
Contact Details
Name: Takeshi Kato, M.D., Ph.D.
Affiliation: Department of Surgery, National Hospital Organization Osaka National Hospital.
Role: PRINCIPAL_INVESTIGATOR
Name: Akihito Tsuji, M.D., Ph.D.
Affiliation: Department of Medical Oncology, Kagawa University Hospital.
Role: PRINCIPAL_INVESTIGATOR
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