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

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06195111
• Other study ID #: 2023-0994
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Ying Yuan, ph.D & MD
• Phone: +86-13858193601
• Email: yuanying1999[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Trifluridine/Tipiracil
This a rospective observational study. There is no treatment allocation. Patients administered Trifluridine/Tipiracil by prescription

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS (Progression-free survival)	Progression-free survival defined as the time elapsed between the randomization and the date of radiologic tumour progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.	Approximately 12 months
Secondary	OS (Overall Survival)	Overall survival defined as the observed time elapsed between the date of first treatment and the date of death due to any cause.	Approximately 12 months
Secondary	ORR(Objective response rate)	Objective Response Rate defined as the proportion of patients with objective evidence of complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria and using investigator's tumor assessment.	Approximately 12 months
Secondary	DCR (Disease control rate)	Disease control rate defined as the proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST version 1.1 criteria and using investigator's tumor assessment.	Approximately 12 months
Secondary	Quality of life: EORTC QLQ-C30	Assess patients health and activities using the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30) module.	Approximately 12 months