JPRN-jRCT1080223562
Completed
Phase 2
A randomized phase 2/3 study of fluoropyrimidine and irinotecan plus bevacizumab versus trifluridine/tipiracil plus bevacizumab as second-line treatment in patients with metastatic colorectal cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Enrollment
- 524
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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