A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With mCRC (REFLECT Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trifluridine/Tipiracil.
- Who it may be relevant to
- Registry conditions: Metastatic Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With Metastatic Colorectal Cancer (REFLECT Study)
Overview
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.
Detailed description
This is a non-randomized, uncontrolled, multicenter real-world study. The total number of subjects is 200. The objective is to observe and evaluate the efficacy and safety of Trifluridine/Tipiracil alone or in combination with other therapies in the treatment of metastatic colorectal cancer in real-world environment. The primary endpoints is Progression-free survival (PFS). Secondary endpoints are overall survival (OS), Objective response rate(ORR), Disease control rate(DCR), progression-free survival (PFS), and Quality of life (QoL).
Interventions
- Drug Trifluridine/Tipiracil
This a rospective observational study. There is no treatment allocation. Patients administered Trifluridine/Tipiracil by prescription
Primary outcome measures
- PFS (Progression-free survival) [Time frame: Approximately 12 months]
Secondary outcome measures (4)
- OS (Overall Survival) [Time frame: Approximately 12 months]
- ORR（Objective response rate） [Time frame: Approximately 12 months]
- DCR (Disease control rate) [Time frame: Approximately 12 months]
- Quality of life: EORTC QLQ-C30 [Time frame: 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06195111 · 2023-0994