Trifluridin/tipirACil in meTastatIc Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Non-interventional Study to Assess Effectiveness and Safety of Trifluridin/Tipiracil in Patients With Metastatic Colorectal Cancer

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Trifluridin/Tipiracil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Trifluridin/Tipiracil|QoL assessment|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | time from first administration of trifluridin/tipiracil to death from any cause | Baseline up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | PFS: time from first administration of trifluridin/tipiracil to disease progression or death from any cause | Baseline up to 3 years | 
| Overall response rate | ORR: the proportion of patients whose best response was a complete or partial response | Baseline up to 3 years | 
| Disease control rate 8 weeks | 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 | Baseline up to 3 years | 
| Trifluridin/tipiracil treatment details | Line of Trifluridin/Tipiracil treatment (Descriptive statistics using frequency tables will be used to assess the number of prior palliative systemic antineoplastic treatment regimen) | Baseline | 
| Trifluridin/tipiracil treatment details | Treatment duration | Baseline up to 3 years | 
| Trifluridin/tipiracil treatment details | Dose intensity (absolute and relative) | Baseline up to 3 years | 
| Trifluridin/tipiracil treatment details | 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.) | Baseline up to 3 years | 
| AEs and SAEs according to NCI CTCAE | AEs and SAEs according to NCI CTCAE | Baseline up to 3 years | 
| Safety laboratory values of participants | 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. | Baseline up to 3 years | 
| Therapy management (use of relevant supportive medications) | Number of patients receiving G-CSFs for prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia (Frequencies) | Baseline up to 3 years | 
| Patient-reported outcomes (PROs) on quality of life (QoL) | PRO-CTCAE: Questionnaire PRO-CTCAE is used to determine patients' symptomatic toxicity. Item cluster scores of PRO-CTCAE questionnaire at each visit and change from baseline of scores. | Baseline up to 3 years | 
| Patient-reported outcomes (PROs) on quality of life (QoL) | 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. | Baseline up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mCRC, Trifluridin/Tipiracil