A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece

Hellenic Study Group of Psychoneuroimmunology in Cancer200 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Metastatic Colorectal Cancer

Interventions

Trifluridine/TipiracilDRUG

Trifluridine/ Tipiracil is an oral combination of an antineoplastic thymidine-based nucleoside analogue, trifluridine, and the thymidine phosphorylase (TPase) inhibitor, tipiracil hydrochloride.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (8)

University General Hospital of Heraklion (PAGNI)

Heraklion, Crete, Greece

General Hospital "Venizeleio - Pananio"

Heraklion, Crete, Greece

Athens Medical Group

Athens, Greece

General Oncological Hospital "Agioi Anargyroi"

Athens, Greece

Outcomes

Primary Outcomes

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.

Time frame: Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.

Secondary Outcomes

Overall Survival

Overall survival is defined as the time interval from initiation of treatment to the date of death due to any cause.

Time frame: 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.

Time frame: 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).

Time frame: Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.

Data from ClinicalTrials.gov

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