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

JRCT ID: jRCTs041180166

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: First-line treatment in patients with metastatic colorectal cancer
• Date of first enrollment: 29/03/2019
• Target sample size: 120
• Study type: Interventional

Intervention(s)

Arm A: FOLFIRI plus ramucirumab (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 weeks

Arm B: FOLFOXIRI plus Rmab treatment
Induction therapy: 8 courses (maximum of 12 courses)
- Rmab: 8 mg/kg/day1
- IRI: 165 mg/m2/day1
- l-LV: 200 mg/m2/day1
- oxaliplatin (OX): 85 mg/m2/day1
- infusional 5-FU: 3200 mg/m2/day1-3
Every 2 weeks

Maintenance therapy: 5-FU/l-LV+Rmab, every 2 weeks

Outcome(s)

• Primary Outcome: Objective response rate
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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.

Exclude criteria

1) Serious complications.
2) Receipt of a blood transfusion or hematopoietic factor therapy within 2 weeks prior to registration.
3) Grade 2 or worse peripheral sensory neuropathy.
4) History of Grade 3 or worse 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.

Related Information

• Primary Sponsor: Kito Yosuke
• Source(s) of Monetary Support: Eli Lilly Japan K.K.
• Secondary ID(s): UMIN000027210