Randomized phase II study of FOLFIRI plus ramucirumab versus FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer(WJOG9216G)

Randomized phase II study of FOLFIRI plus ramucirumab versus FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer(WJOG9216G) - Randomized phase II study of FOLFIRI plus ramucirumab versus FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer(WJOG9216G, RECAST)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026527

Enrollment

120

Registered

2017-03-24

Start date

2017-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

first-line treatment in patients with metastatic colorectal cancer

Interventions

Arm A: FOLFIRI+Rmab treatment Rmab:8 mg/kg/day1 l-leucovorin (l-LV):200 mg/m2/day1 irinotecan (IRI): 180 mg/m2/day1 bolus 5-FU:400 mg/m2/day1 infusional 5-FU:2400 mg/m2/day1-3 Every 2 eeks Arm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically diagnosed adenocarcinoma of the colon or rectum (excluding the appendix and anal canal). 2) Tumor is clinically determined to be unresectable for a radical cure. 3) Age of 20-75 years. 4) ECOG PS of 0-1 (a PS 0 is required for subjects aged 71-75 years). 5) Measurable lesion according to RECIST, version 1.1. 6) No history of chemotherapy (however, subjects may register if they have received adjuvant chemotherapy with fluoropyrimidine monotherapy and the cancer recurrence occurred >=24 weeks after the last dose. Patients who have received OX-based adjuvant chemotherapy may not register.) 7) Retained organ function. 8) UGT1A1 gene status of wild type (*1/*1), or *28, *6 genetic polymorphism single hetero-type (*1/*28, *1/*6). 9) The RAS mutation status (wild-type, mutant or not definable) of the patients is known prior to randomization.

Exclusion criteria

Exclusion criteria: 1) Serious complications. 2) Receipt of a blood transfusion or hematopoietic factor therapy within 2 weeks prior to registration. 3) Grade >=2 peripheral sensory neuropathy. 4) History of Grade >=3 thromboembolism within 6 months before the scheduled treatment start date. 5) Receiving anti-platelet agents. Aspirin use at doses up to 325 mg/day is permitted. 6) Women who are pregnant, breastfeeding, had a positive pregnancy test, or women and men who do not wish to use contraception.

Design outcomes

Primary

Measure	Time frame
Objective response rate	—

Secondary

Measure	Time frame
Overall survival,progression-free survival,time to treatment failure, time to second progression or death, early tumor shrinkage, depth of response, R0 resection rate, and safety	—

Countries

Japan

Contacts

Public ContactNaoki Ishizuka

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026