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

NCT06195111 | Not Yet Recruiting

• 1 other identifier: 2023-0994
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• OS (Overall Survival)

  Approximately 12 months

• ORR（Objective response rate）

  Approximately 12 months

• DCR (Disease control rate)

  Approximately 12 months

• Quality of life: EORTC QLQ-C30

  Approximately 12 months

Study Arms (1)

Trifluridine/Tipiracil

Patients with metastatic colorectal cancer plan to recieve Trifluridine/Tipiracil-containing treatment will be enrolled in this study. The prescription all determined by doctor based on patient's situation.

Drug: Trifluridine/Tipiracil

Interventions

Trifluridine/Tipiracil DRUG

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

Also known as: TAS-102, FTD/TPI, Lonsurf

Trifluridine/Tipiracil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients, being treated for mCRC with Trifluridine/Tipiracil-containing regimen.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Ying Yuan, ph.D & MD

CONTACT

+86-13858193601; yuanying1999@zju.edu.cn

Dan Li, ph.D & MD

CONTACT

+86-15868405387; li_dan@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: January 8, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 8, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share