Clinical trial

A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With Metastatic Colorectal Cancer (REFLECT Study)

Name
2023-0994
Description
A real-world study of trifluridine/tipiracil containing regimen for the treatment of patients with metastatic colorectal cancer. A total of 200 patients planned to be enrolled.
Trial arms
Trial start
2024-03-01
Estimated PCD
2027-03-01
Trial end
2027-12-31
Status
Not yet recruiting
Treatment
Trifluridine/Tipiracil
This a rospective observational study. There is no treatment allocation. Patients administered Trifluridine/Tipiracil by prescription
Arms:
Trifluridine/Tipiracil
Other names:
TAS-102, FTD/TPI, Lonsurf
Size
200
Primary endpoint
PFS (Progression-free survival)
Approximately 12 months
Eligibility criteria
Inclusion Criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria at enrollment: * Male and female patients with ≥18 years of age; * Patients with metastatic colorectal cancer confirmed by histopathology; * Be willing to use reliable contraceptive methods and refrain from sperm donation throughout the study period and within 3 months after the last dose; * Voluntarily join the study and provide written informed consent to participate in the study; * Have traceable medical history during the treatment; * Doctor believe the patients can benefit from the study. Exclusion Criteria: Patients fulfilling any of the following criteria at enrollment are not eligible for inclusion in this study: * Failure to sign informed consent; * Patients with contraindications to Trifluridine/Tipiracil; * Female subjects who have a positive pregnancy test or are breastfeeding; * Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2024-01-08

1 organization

1 product

1 indication