CAPOXIRI+Bevacizumab vs. FOLFOXIRI+Bevacizumab for mCRC
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Colorectal Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 125 years
- Gender
- Both males and females
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. Dose finding step (Step1): CAPO...
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. Dose finding step (Step1): CAPOXIRI+BEV doses findings were planned by 3+3 cohort design, register up to maximum of 12 cases. 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.
Tracking Information
- NCT #
- NCT04097444
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Takeshi Kato, M.D., Ph.D. Department of Surgery, National Hospital Organization Osaka National Hospital. Principal Investigator: Akihito Tsuji, M.D., Ph.D. Department of Medical Oncology, Kagawa University Hospital.
Get Well Soon