Skip to main content
OpenTrials
Completed

NCT Number: NCT04965870

A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital "Venizeleio - Pananio", Heraklion, Crete, Greece

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trifluridine/tipiracil

Drug

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

Other names: FTD/TPI, TAS 102

Primary outcomes

  1. Progression Free Survival

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

    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.

Secondary outcomes

  1. Overall Survival

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

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

  2. Progression Free Survival rate at 6 and 8 months

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

    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.

  3. Disease Control Rate

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

    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).

Sponsors and collaborators

Lead sponsor

Hellenic Study Group of Psychoneuroimmunology in Cancer

Network

Collaborators

  • Servier

Registry information

Official study title

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

Acronym: RETRO-TAS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2021
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.