A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece

NCT ID: NCT04965870

Last Updated: 2022-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-30

Study Completion Date

2021-12-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Metastatic Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Trifluridine/Tipiracil

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

Intervention Type DRUG

Other Intervention Names

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FTD/TPI TAS 102

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Servier

INDUSTRY

Sponsor Role collaborator

Hellenic Study Group of Psychoneuroimmunology in Cancer

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ANNA KOUMARIANOU, PhD

Role: PRINCIPAL_INVESTIGATOR

4th Department of Internal Medicine, Attikon University Hospital

Locations

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University General Hospital of Heraklion (PAGNI)

Heraklion, Crete, Greece

Site Status

General Hospital "Venizeleio - Pananio"

Heraklion, Crete, Greece

Site Status

Athens Medical Group

Athens, , Greece

Site Status

General Oncological Hospital "Agioi Anargyroi"

Athens, , Greece

Site Status

Agios Savvas Cancer Hospital

Athens, , Greece

Site Status

Attikon University Hospital

Athens, , Greece

Site Status

Anticancer Hospital "METAXA"

Piraeus, , Greece

Site Status

Bioclinic

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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2021-01

Identifier Type: -

Identifier Source: org_study_id

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