A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece

Study Overview
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Brief Summary
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Collection of real world data on the clinical efficacy of trifluridine/ tipiracil (FTD/TPI) in the Greek population.

Detailed Description
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The aim of this analysis is to record clinical practice and to collect real world data on the clinical efficacy of trifluridine/ tipiracil (FTD/TPI) in the Greek population. Main objectives include to assess physician's choice of treatment in chemoresistant metastatic colorectal cancer with FTD/TPI in third line and beyond In addition, the clinicopathologic features related to metastatic colorectal cancer (focus on molecular profile), duration of treatment, dose modification and toxicity will be analyzed.

Official Title
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A Retrospective Observational Study of Trifluridine/ Tipiracil (TAS-102) in Chemorefractory Metastatic Colorectal Cancer (mCRC) in Greece. Real World Data on Clinical Benefit.

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Trifluridine/Tipiracil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Histologically confirmed metastatic colorectal cancer Available data on previous chemotherapy lines Exclusion Criteria: No exclusion criteria have been established for this observational and retrospective study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Trifluridine/Tipiracil|Trifluridine/ Tipiracil is an oral combination of an antineoplastic thymidine-based nucleoside analogue, trifluridine, and the thymidine phosphorylase (TPase) inhibitor, tipiracil hydrochloride.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | PFS is defined as the time interval from initiation of treatment to the first date of documented tumor progression or death from any cause, whichever occurs first. | Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival is defined as the time interval from initiation of treatment to the date of death due to any cause. | Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study. | 
| Progression Free Survival rate at 6 and 8 months | PFS rate at 6 and 8 months corresponding to the percentage of patients surviving without any documented progression of the disease at 6 and 8 months after treatment initiation. | Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study. | 
| Disease Control Rate | The DCR is defined as the proportion of patients with objective evidence of complete response (CR), the proportion of patients with objective evidence of partial response (PR), and the proportion of patients with objective evidence of stable disease (SD). | Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study. |