drugset / Trial / NCT04097444
CAPOXIRI+Bevacizumab vs. FOLFOXIRI+Bevacizumab for mCRC
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2019-10-11
- Primary completion
- 2022-08-31
- Completion
- 2022-08-31
Outcome
Met primary endpoint
paper The study met its primary endpoint; PFS at median follow-up of 23.7 months was 10.6 months PMID 38901425 ↗
Publications
- Bando H, Kotani D, Satake H, Hamaguchi T, Shiozawa M, Kotaka M, Masuishi T, Yasui H, Kagawa Y, Komatsu Y, Oki E, Yamamoto Y, Kawakami H, Misumi T, Taniguchi H, Yamazaki K, Muro K, Yoshino T, Kato T, Tsuji A. QUATTRO-II randomized trial: CAPOXIRI+bevacizumab vs. FOLFOXIRI+bevacizumab as first-line treatment in patients with mCRC. Med. 2024 Sep 13;5(9):1164-1177.e3. doi: 10.1016/j.medj.2024.05.012. Epub 2024 Jun 19.
- Kotani D, Yoshino T, Kotaka M, Kawazoe A, Masuishi T, Taniguchi H, Yamazaki K, Yamanaka T, Oki E, Muro K, Komatsu Y, Bando H, Satake H, Kato T, Tsuji A. Combination therapy of capecitabine, irinotecan, oxaliplatin, and bevacizumab as a first-line treatment for metastatic colorectal cancer: Safety lead-in results from the QUATTRO-II study. Invest New Drugs. 2021 Dec;39(6):1649-1655. doi: 10.1007/s10637-021-01125-2. Epub 2021 May 21.
- Miyo M, Kato T, Yoshino T, Yamanaka T, Bando H, Satake H, Yamazaki K, Taniguchi H, Oki E, Kotaka M, Oba K, Miyata Y, Muro K, Komatsu Y, Baba H, Tsuji A. Protocol of the QUATTRO-II study: a multicenter randomized phase II study comparing CAPOXIRI plus bevacizumab with FOLFOXIRI plus bevacizumab as a first-line treatment in patients with metastatic colorectal cancer. BMC Cancer. 2020 Jul 23;20(1):687. doi: 10.1186/s12885-020-07186-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Capecitabine | Small molecule | 1600 mg/m2 | Oral |
| Subject | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 165 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 3200 mg/m2 | Intravenous |