Randomized phase II study of FOLFIRI plus ramucirumab versus FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer (WJOG9216G)
- Conditions
- First-line treatment in patients with metastatic colorectal cancer
- Registration Number
- JPRN-jRCTs041180166
- Lead Sponsor
- Kito Yosuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method