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| Name | Class |
|---|---|
| Servier | INDUSTRY |
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Collection of real world data on the clinical efficacy of trifluridine/ tipiracil (FTD/TPI) in the Greek population.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifluridine/Tipiracil | Drug | Trifluridine/ Tipiracil is an oral combination of an antineoplastic thymidine-based nucleoside analogue, trifluridine, and the thymidine phosphorylase (TPase) inhibitor, tipiracil hydrochloride. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 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. | Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival is defined as the time interval from initiation of treatment to the date of death due to any cause. | Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study. |
| Progression Free Survival rate at 6 and 8 months |
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Inclusion Criteria:
Exclusion Criteria:
No exclusion criteria have been established for this observational and retrospective study.
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Greek patients with mCRC
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| Name | Affiliation | Role |
|---|---|---|
| ANNA KOUMARIANOU, PhD | 4th Department of Internal Medicine, Attikon University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital of Heraklion (PAGNI) | Heraklion | Crete | 70013 | Greece | ||
| General Hospital "Venizeleio - Pananio" |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000613803 | trifluridine tipiracil drug combination |
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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. |
| Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study. |
| Disease Control Rate | 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). | Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study. |
| Heraklion |
| Crete |
| 71409 |
| Greece |
| Athens Medical Group | Athens | 11525 | Greece |
| General Oncological Hospital "Agioi Anargyroi" | Athens | 14564 | Greece |
| Agios Savvas Cancer Hospital | Athens | Greece |
| Attikon University Hospital | Athens | Greece |
| Anticancer Hospital "METAXA" | Piraeus | 18537 | Greece |
| Bioclinic | Thessaloniki | Greece |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |