A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece
- Conditions
- Metastatic Colorectal Cancer
- Registration Number
- NCT04965870
- Lead Sponsor
- Hellenic Study Group of Psychoneuroimmunology in 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Age > 18 years
- Histologically confirmed metastatic colorectal cancer
- Available data on previous chemotherapy lines
No exclusion criteria have been established for this observational and retrospective study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival Retrospective 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 Outcome Measures
Name Time Method Overall Survival 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.
Progression Free Survival rate at 6 and 8 months Retrospective 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 Rate Retrospective 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).
Trial Locations
- Locations (8)
University General Hospital of Heraklion (PAGNI)
🇬🇷Heraklion, Crete, Greece
General Oncological Hospital "Agioi Anargyroi"
🇬🇷Athens, Greece
Anticancer Hospital "METAXA"
🇬🇷Piraeus, Greece
General Hospital "Venizeleio - Pananio"
🇬🇷Heraklion, Crete, Greece
Agios Savvas Cancer Hospital
🇬🇷Athens, Greece
Attikon University Hospital
🇬🇷Athens, Greece
Bioclinic
🇬🇷Thessaloniki, Greece
Athens Medical Group
🇬🇷Athens, Greece