NCT04097444

CAPOXIRI+Bevacizumab vs. FOLFOXIRI+Bevacizumab for mCRC

Quadruplet 1st Line Treatment of CAPOXIRI Plus Bevacizumab Versus FOLFOXIRI Plus Bevacizumab for mCRC, Multicenter Randomised Phase II Study (QUATTRO-II)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Given IV
DRUG	5-fluorouracil	Given IV
DRUG	Leucovorin calcium	Given IV
DRUG	Irinotecan hydrochloride	Given IV
DRUG	Oxaliplatin	Given IV
DRUG	Capecitabine	Given PO

Timeline

• Start date: 2019-10-11
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2019-09-20
• Last updated: 2019-10-31

Locations

1 site across 1 country: Japan