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A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04965870
Acronym
RETRO-TAS
Enrollment
200
Registered
2021-07-16
Start date
2021-06-30
Completion date
2021-12-20
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Brief summary

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

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.

Interventions

DRUGTrifluridine/Tipiracil

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

Sponsors

Servier
CollaboratorINDUSTRY
Hellenic Study Group of Psychoneuroimmunology in Cancer
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years * Histologically confirmed metastatic colorectal cancer * Available data on previous chemotherapy lines

Exclusion criteria

No

Design outcomes

Primary

MeasureTime frameDescription
Progression Free SurvivalRetrospective 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

MeasureTime frameDescription
Overall SurvivalRetrospective 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.
Progression Free Survival rate at 6 and 8 monthsRetrospective 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.
Disease Control RateRetrospective 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).

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026