- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04965870
A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece (RETRO-TAS)
March 4, 2022 updated by: Hellenic Study Group of Psychoneuroimmunology in Cancer
A Retrospective Observational Study of Trifluridine/ Tipiracil (TAS-102) in Chemorefractory Metastatic Colorectal Cancer (mCRC) in Greece. Real World Data on Clinical Benefit.
Collection of real world data on the clinical efficacy of trifluridine/ tipiracil (FTD/TPI) in the Greek population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Athens, Greece
- Attikon University Hospital
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Athens, Greece, 11525
- Athens Medical Group
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Athens, Greece, 14564
- General Oncological Hospital "Agioi Anargyroi"
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Athens, Greece
- Agios Savvas Cancer Hospital
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Piraeus, Greece, 18537
- Anticancer Hospital "METAXA"
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Thessaloniki, Greece
- Bioclinic
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Crete
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Heraklion, Crete, Greece, 70013
- University General Hospital of Heraklion (PAGNI)
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Heraklion, Crete, Greece, 71409
- General Hospital "Venizeleio - Pananio"
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Greek patients with mCRC
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
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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.
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Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: Retrospective 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.
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Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
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Progression Free Survival rate at 6 and 8 months
Time Frame: Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
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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.
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Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
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Disease Control Rate
Time Frame: Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
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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).
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Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: ANNA KOUMARIANOU, PhD, 4th Department of Internal Medicine, Attikon University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2021
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
December 20, 2021
Study Registration Dates
First Submitted
June 28, 2021
First Submitted That Met QC Criteria
July 7, 2021
First Posted (Actual)
July 16, 2021
Study Record Updates
Last Update Posted (Actual)
March 7, 2022
Last Update Submitted That Met QC Criteria
March 4, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Trifluridine
Other Study ID Numbers
- 2021-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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