Phase 2/3 study of fluoropyrimidine and irinotecan plus bevacizumab versus trifluridine/tipiracil plus bevacizumab as second-line for metastatic colorectal cancer (TRUSTY)

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080223562

Enrollment

524

Registered

2017-06-16

Start date

2017-10-02

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

metastatic colorectal cancer

Interventions

investigational material(s) Generic name etc : trifluridine/tipiracil INN of investigational material : trifluridine/tipiracil Therapeutic category code : 429 Other antitumor agents Dosage and Adminis

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: -

Design outcomes

Primary

Measure	Time frame
efficacy Overall survival	—

Secondary

Measure	Time frame
safety efficacy Quality of life Proportion of patients switching to subsequent treatment Progression-free survival Time to treatment failure Time to post-study treatment failure Response rate Disease control Rate Adverse event	—

Countries

Japan

Outcome results

None listed

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