Metastatic Colorectal CancerRETRO-TASNCT04965870
A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece
An observational study of Metastatic Colorectal Cancer, run by Hellenic Study Group of Psychoneuroimmunology in Cancer at 8 sites in Greece.
Trial summary
Collection of real world data on the clinical efficacy of trifluridine/ tipiracil (FTD/TPI) in the Greek population. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Trifluridine/Tipiracil
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 8 sitesGreece
- Study dates
- 30 Jun 2021to 20 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Greek patients with mCRC
Who may be able to join
- Age > 18 years
- Histologically confirmed metastatic colorectal cancer
- Available data on previous chemotherapy lines
Who cannot join
- No exclusion criteria have been established for this observational and retrospective study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Greece8 sites
Athens Medical Group
Athens, 11525
General Oncological Hospital "Agioi Anargyroi"
Athens, 14564
Agios Savvas Cancer Hospital
Athens
Attikon University Hospital
Athens
University General Hospital of Heraklion (PAGNI)
Heraklion, Crete, 70013
General Hospital "Venizeleio - Pananio"
Heraklion, Crete, 71409
Anticancer Hospital "METAXA"
Piraeus, 18537
Bioclinic
Thessaloniki
About this study
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.
Collection of real world data on the clinical efficacy of trifluridine/ tipiracil (FTD/TPI) in the Greek population.
Read the 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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Trifluridine/Tipiracil
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifluridine/TipiracilDrug
Also called FTD/TPI, TAS 102
Trifluridine/ Tipiracil is an oral combination of an antineoplastic thymidine-based nucleoside analogue, trifluridine, and the thymidine phosphorylase (TPase) inhibitor, tipiracil hydrochloride.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
Secondary outcomes (3)
Overall Survival
Overall survival is defined as the time interval from initiation of treatment to the date of death due to any cause.
Measured: 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
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.
Measured: 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).
Measured: Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start30 Jun 2021
- Primary completion31 Oct 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Study Group of Psychoneuroimmunology in Cancer
- Sponsor type
- Research network
- Collaborators
- Servier
- Responsible party
- Sponsor
- Investigators
- ANNA KOUMARIANOU, PhD, Principal investigator, 4th Department of Internal Medicine, Attikon University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965870
- Sponsor's protocol ID
- 2021-01
- Acronym
- RETRO-TAS
- Status last verified
- Mar 2022
- First submitted
- 28 Jun 2021
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04965870
- Acronym / sponsor ID
- RETRO-TAS / 2021-01
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hellenic Study Group of Psychoneuroimmunology in CancerResearch network
- Collaborators
- Servier
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Greek patients with mCRC
Key inclusion criteria (3 listed)
- Age > 18 years
- Histologically confirmed metastatic colorectal cancer
- Available data on previous chemotherapy lines
Key exclusion criteria (1 listed)
- No exclusion criteria have been established for this observational and retrospective study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trifluridine/TipiracilAlso: FTD/TPI, TAS 102Trifluridine/ Tipiracil is an oral combination of an antineoplastic thymidine-based nucleoside analogue, trifluridine, and the thymidine phosphorylase (TPase) inhibitor, tipiracil hydrochloride. | Drug | – |
Primary outcome
Progression Free Survival
Time frame: 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.
3 secondary outcomes
Overall Survival
Time frame: 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
Time frame: Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
Disease Control Rate
Time frame: Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Individual participant dataSharing planned: No
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANNA KOUMARIANOU, PhD principal investigator
4th Department of Internal Medicine, Attikon University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Hellenic Study Group of Psychoneuroimmunology in Cancer at 8 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.