NCT07494578

Brief Summary

This study will enroll patients with metastatic colorectal cancer treated with the combination of Trifluridine/Tipiracile and Bevacizumab across 15 italian centers.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Jul 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jul 2025Aug 2027

Study Start

First participant enrolled

July 1, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 27, 2026

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

July 17, 2025

Last Update Submit

March 25, 2026

Conditions

Colon Cancer Metastatic

Keywords

Colon CancerTrifluridine/TipiracileBevacizumabFluoropyrimidines

Outcome Measures

Primary Outcomes (2)

  • Overall Survival

    Time from start of the treatment to death from any cause up to 30 months from the date of treatments' start.

    up to 30 months from the date of treatments' start

  • Progression-free survival

    time from the start of the treatment to disease progression or death from any cause, whichever occurred first, up to 30 months from the date of treatments' start.

    up to 30 months from the date of treatments' start

Interventions

FluoropyrimidineDRUG

Treatment with fluoropyrimidines and bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with metastatic colorectal cancer treated with fluoropyrimidines and bevacizumab.

You may qualify if:

  • Age ≥18 years;
  • ECOG PS 0-2;
  • Histologic diagnosis of colorectal cancer;
  • Treatment with fluoropyrimidine plus bevacizumab.

You may not qualify if:

  • ECOG PS ≥3;
  • Absence of histologic diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00160, Italy

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Lisa Salvatore

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DOCTOR

Study Record Dates

First Submitted

July 17, 2025

First Posted

March 27, 2026

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

March 27, 2026

Record last verified: 2025-08

Locations

IT(1)