A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece

Metastatic Colorectal Cancer Clinical Trial

— RETRO-TAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04965870
• Other study ID #: 2021-01
• Status: Completed
• Start date: June 30, 2021
• Est. completion date: December 20, 2021

Study information

• Verified date: March 2022
• Source: Hellenic Study Group of Psychoneuroimmunology in Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 20, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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.

Locations

Country	Name	City	State
Greece	Agios Savvas Cancer Hospital	Athens
Greece	Athens Medical Group	Athens
Greece	Attikon University Hospital	Athens
Greece	General Oncological Hospital "Agioi Anargyroi"	Athens
Greece	General Hospital "Venizeleio - Pananio"	Heraklion	Crete
Greece	University General Hospital of Heraklion (PAGNI)	Heraklion	Crete
Greece	Anticancer Hospital "METAXA"	Piraeus
Greece	Bioclinic	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Study Group of Psychoneuroimmunology in Cancer	Servier

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.