Clinical trial NCT04965870: A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Hellenic Study Group of Psychoneuroimmunology in Cancer
Sponsor class: NETWORK
Collaborators: name: Servier
First posted: 2021-07-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Greek patients with mCRC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
Secondary outcomes:
measure: Overall Survival
timeFrame: Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
measure: Progression Free Survival rate at 6 and 8 months
timeFrame: Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
measure: Disease Control Rate
timeFrame: Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion (PAGNI)
state: Crete
city: Heraklion
country: Greece
facility: General Hospital "Venizeleio - Pananio"
state: Crete
city: Athens
country: Greece
facility: Athens Medical Group
city: Athens
country: Greece
facility: General Oncological Hospital "Agioi Anargyroi"
city: Athens
country: Greece
facility: Agios Savvas Cancer Hospital
city: Athens
country: Greece
facility: Attikon University Hospital
city: Piraeus
country: Greece
facility: Anticancer Hospital "METAXA"
city: Thessaloniki
country: Greece
facility: Bioclinic
Study officials:
affiliation: 4th Department of Internal Medicine, Attikon University Hospital
name: ANNA KOUMARIANOU, PhD
role: PRINCIPAL_INVESTIGATOR
References: