Trifluridin/tipirACil in MeTastatIc Colorectal Cancer

Completed

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT03665506
• Lead Sponsor: Servier

Brief Summary

A non-interventional, prospective, open, multicenter study in Germany in patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies and with decision for treatment with trifluridin/tipiracil.

Detailed Description

The purpose of this NIS, after market approval of trifluridin/tipiracil as treatment for mCRC patients who have been previously treated with, or are not considered candidates for, available therapies, is to evaluate effectiveness, QoL, treatment details and safety of trifluridin/tipiracil treatment in a real-world setting. In addition, therapy management and health economic parameters regarding trifluridin/tipiracil treatment will be assessed.

Study Timeline

• Study Start: 2018-06-25
• Study First Submitted: 2018-08-26
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Primary Completion: 2021-08-02
• Study Completion: 2021-08-02
• Status Verified: 2021-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

• Aged 18 years or older.
• Patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
• Indication for treatment as assessed by the treating physician.
• Decision for treatment with trifluridin/tipiracil.
• Signed written informed consent.
• Criteria according to current Summary of Product Characteristics (SmPC) for patients treated with trifluridin/tipiracil.
• Ability to read and understand German.

Exclusion Criteria

• Contraindications according to SmPC for metastatic colorectal cancer patients treated with trifluridin/tipiracil.
• Participation in a clinical trial within 30 days prior to enrollment or simultaneous participation in a clinical trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	Baseline up to 3 years	time from first administration of trifluridin/tipiracil to death from any cause

Secondary Outcome Measures

Name	Time	Method
Trifluridin/tipiracil treatment details	Baseline up to 3 years	Treatment sequence (previous and subsequent therapies in relation to Trifluridin/Tipiracil treatment) (Descriptive statistics using frequency tables will be used to assess previous and subsequent palliative systemic antineoplastic treatment regimen used.)
Safety laboratory values of participants	Baseline up to 3 years	By-patient display of all safety laboratory results captured as per clinical routine (e.g. CEA, CA 19-9, haemoglobin, neutrophils absolute, lymphocytes count, platelets count, leukocytes count, alkaline phosphatase, ALT (GPT), AST (GOT), bilirubin total and serum creatinine). In addition, CTCAE grades of neutrophils, white blood cell count, platelets, haemoglobin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, alkaline phosphatase and creatinine will be presented using frequencies and percentages for each visit. Shift tables opposing CTCAE grades during treatment to baseline CTCAE grades of the mentioned parameters will also be presented per visit using frequencies and percentages.
Progression-free survival	Baseline up to 3 years	PFS: time from first administration of trifluridin/tipiracil to disease progression or death from any cause
Overall response rate	Baseline up to 3 years	ORR: the proportion of patients whose best response was a complete or partial response
Disease control rate 8 weeks	Baseline up to 3 years	DCR-8: the proportion of patients with a best response of complete or partial response or stable disease, with the assessment of stable disease made at least 8 weeks after first administration of trifluridin/tipiracil
AEs and SAEs according to NCI CTCAE	Baseline up to 3 years	AEs and SAEs according to NCI CTCAE
Therapy management (use of relevant supportive medications)	Baseline up to 3 years	Number of patients receiving G-CSFs for prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia (Frequencies)
Patient-reported outcomes (PROs) on quality of life (QoL)	Baseline up to 3 years	EQ-5D-5L: Questionnaire EQ-5D-5L is used to determine patients' health related quality of life. EQ-5D-5L index and visual analogue score at each visit and change from baseline for both, index and visual analogue score.

Trial Locations

Locations (1)

Onkologische Schwerpunktpraxis Kurfürstendamm; 🇩🇪 Berlin, Germany