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.
1 other identifier
observational
200
1 country
8
Brief Summary
Collection of real world data on the clinical efficacy of trifluridine/ tipiracil (FTD/TPI) in the Greek population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2021
CompletedStudy Start
First participant enrolled
June 30, 2021
CompletedFirst Posted
Study publicly available on registry
July 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2021
CompletedMarch 7, 2022
March 1, 2022
4 months
June 28, 2021
March 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Overall Survival
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
Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
Disease Control Rate
Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
Interventions
Trifluridine/ Tipiracil is an oral combination of an antineoplastic thymidine-based nucleoside analogue, trifluridine, and the thymidine phosphorylase (TPase) inhibitor, tipiracil hydrochloride.
Eligibility Criteria
Greek patients with mCRC
You may qualify if:
- Age \> 18 years
- Histologically confirmed metastatic colorectal cancer
- Available data on previous chemotherapy lines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hellenic Study Group of Psychoneuroimmunology in Cancerlead
- Serviercollaborator
Study Sites (8)
University General Hospital of Heraklion (PAGNI)
Heraklion, Crete, 70013, Greece
General Hospital "Venizeleio - Pananio"
Heraklion, Crete, 71409, Greece
Athens Medical Group
Athens, 11525, Greece
General Oncological Hospital "Agioi Anargyroi"
Athens, 14564, Greece
Agios Savvas Cancer Hospital
Athens, Greece
Attikon University Hospital
Athens, Greece
Anticancer Hospital "METAXA"
Piraeus, 18537, Greece
Bioclinic
Thessaloniki, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ANNA KOUMARIANOU, PhD
4th Department of Internal Medicine, Attikon University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2021
First Posted
July 16, 2021
Study Start
June 30, 2021
Primary Completion
October 31, 2021
Study Completion
December 20, 2021
Last Updated
March 7, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share