Phase 2/3 study of fluoropyrimidine and irinotecan plus bevacizumab versus trifluridine/tipiracil plus bevacizumab as second-line for metastatic colorectal cancer (TRUSTY)
- Conditions
- metastatic colorectal cancer
- Registration Number
- JPRN-jRCT1080223562
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 524
(1) A histopathologically or cytologically confirmed diagnosis of curatively unresectable advanced adenocarcinoma of the colon or rectum for which RAS mutation status has been confirmed on RAS mutation analysis
(2) Curatively unresectable advanced adenocarcinoma of the colon or rectum with no response to first-line treatment with a fluoropyrimidine (5-FU/l-LV, capecitabine, TS-1) + oxaliplatin combined with bevacizumab or an anti-EGFR antibody (cetuximab or panitumumab: only RAS wild-type tumors)
(3) An age of at least 20 years at the time of registration
(4) An ECOG performance status of 0 or 1
(5) Possible to orally administer drugs
(6) Lesions assessable on CT, MRI, etc. confirmed within 28 days before registration (measurable lesions not required)
(7) Main organ functions maintained on examinations performed within 7 days before registration
(8) Written informed consent to participate in the study obtained directly from the patient
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method