A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece (RETRO-TAS)

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

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

Study Overview

• Status: Completed
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: Trifluridine/Tipiracil

Detailed Description

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 (Actual): 200

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Attikon University Hospital
  • Athens, Greece, 11525
    • Athens Medical Group
  • Athens, Greece, 14564
    • General Oncological Hospital "Agioi Anargyroi"
  • Athens, Greece
    • Agios Savvas Cancer Hospital
  • Piraeus, Greece, 18537
    • Anticancer Hospital "METAXA"
  • Thessaloniki, Greece
    • Bioclinic
  • Crete
    • Heraklion, Crete, Greece, 70013
      • University General Hospital of Heraklion (PAGNI)
    • Heraklion, Crete, Greece, 71409
      • General Hospital "Venizeleio - Pananio"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Greek patients with mCRC

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Hellenic Study Group of Psychoneuroimmunology in Cancer
• Collaborators: Servier
• Investigators: Principal Investigator: ANNA KOUMARIANOU, PhD, 4th Department of Internal Medicine, Attikon University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: March 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Trifluridine
• Other Study ID Numbers: 2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No