Colon Cancer MetastaticFLOWERNCT07494578
Observational Study Regarding the Combination of Fluoropyrimidine and Bevacizumab in Patients With mCRC
An observational study of Colon Cancer Metastatic, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This study will enroll patients with metastatic colorectal cancer treated with the combination of Trifluridine/Tipiracile and Bevacizumab across 15 italian centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer Metastatic
- What is being tested?
- Fluoropyrimidine
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2025to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic colorectal cancer treated with fluoropyrimidines and bevacizumab.
Who may be able to join
- Age ≥18 years;
- ECOG PS 0-2;
- Histologic diagnosis of colorectal cancer;
- Treatment with fluoropyrimidine plus bevacizumab.
Who cannot join
- ECOG PS ≥3;
- Absence of histologic diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Observational Study Regarding the Combination of Fluoropyrimidine and Bevacizumab in the Treatment of Patients With Metastatic Colorectal Cancer
This study will enroll patients with metastatic colorectal cancer treated with the combination of Trifluridine/Tipiracile and Bevacizumab across 15 italian centers.
Read the detailed description
The FLOWER study is a multicenter, observational investigation evaluating the real-world effectiveness and safety of a therapeutic combination of fluoropyrimidines and bevacizumab in patients with metastatic colorectal cancer (mCRC).
Colorectal cancer remains one of the most common and lethal cancers in Italy, and although early screening has improved detection rates, a substantial proportion of patients still present with or eventually develop metastatic disease. For those whose tumors do not exhibit specific molecular characteristics (such as dMMR or MSI-high), standard first- and second-line treatments often involve chemotherapy regimens based on fluoropyrimidines combined with agents like oxaliplatin or irinotecan, alongside targeted therapies such as bevacizumab or, in RAS wild-type tumors, anti-EGFR drugs.
However, once patients become refractory to these initial therapies, treatment options become more limited. While some benefit from newer targeted approaches like the combination of cetuximab and encorafenib in BRAF-mutated cancers, many patients without actionable mutations rely on drugs like regorafenib or trifluridine-tipiracil, which have shown only modest benefits. Recent evidence from the SUNLIGHT trial has shown that adding bevacizumab to TAS-102 significantly improves survival in this setting, highlighting the potential benefit of combining antiangiogenic agents with chemotherapy even in heavily pretreated patients. Building on this rationale, the FLOWER study aims to assess how effective and safe the combination of fluoropyrimidines and bevacizumab is when used in daily clinical practice.
The primary objective of the study is to evaluate overall survival, while secondary endpoints include progression-free survival, response rates, safety, and identification of clinical or molecular factors that may predict outcomes. The study will include approximately 300 patients treated between 2023 and 2026. Both retrospective and prospective data will be collected, and no additional procedures, exams, or financial costs are imposed on the healthcare system. The study follows ethical guidelines laid out by the Declaration of Helsinki and has been approved by the regional ethics committee.
- Conditions
- Colon Cancer Metastatic
- Being tested
- Fluoropyrimidine
- Keywords
- Colon Cancer, Trifluridine/Tipiracile, Bevacizumab, Fluoropyrimidines
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoropyrimidineDrug
Treatment with fluoropyrimidines and bevacizumab
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from start of the treatment to death from any cause up to 30 months from the date of treatments' start.
Measured: up to 30 months from the date of treatments' start
Progression-free survival
time from the start of the treatment to disease progression or death from any cause, whichever occurred first, up to 30 months from the date of treatments' start.
Measured: up to 30 months from the date of treatments' start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jul 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Lisa, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Lisa Salvatore, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494578
- Sponsor's protocol ID
- 7242
- Acronym
- FLOWER
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Study Regarding the Combination of Fluoropyrimidine and Bevacizumab in the Treatment of Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07494578
- Acronym / sponsor ID
- FLOWER / 7242
- Conditions
- Colon Cancer Metastatic
- Keywords
- Colon Cancer, Trifluridine/Tipiracile, Bevacizumab, Fluoropyrimidines
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 27 Mar 2026 (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.
This study will enroll patients with metastatic colorectal cancer treated with the combination of Trifluridine/Tipiracile and Bevacizumab across 15 italian centers.
Detailed description
The FLOWER study is a multicenter, observational investigation evaluating the real-world effectiveness and safety of a therapeutic combination of fluoropyrimidines and bevacizumab in patients with metastatic colorectal cancer (mCRC).
Colorectal cancer remains one of the most common and lethal cancers in Italy, and although early screening has improved detection rates, a substantial proportion of patients still present with or eventually develop metastatic disease. For those whose tumors do not exhibit specific molecular characteristics (such as dMMR or MSI-high), standard first- and second-line treatments often involve chemotherapy regimens based on fluoropyrimidines combined with agents like oxaliplatin or irinotecan, alongside targeted therapies such as bevacizumab or, in RAS wild-type tumors, anti-EGFR drugs.
However, once patients become refractory to these initial therapies, treatment options become more limited. While some benefit from newer targeted approaches like the combination of cetuximab and encorafenib in BRAF-mutated cancers, many patients without actionable mutations rely on drugs like regorafenib or trifluridine-tipiracil, which have shown only modest benefits. Recent evidence from the SUNLIGHT trial has shown that adding bevacizumab to TAS-102 significantly improves survival in this setting, highlighting the potential benefit of combining antiangiogenic agents with chemotherapy even in heavily pretreated patients. Building on this rationale, the FLOWER study aims to assess how effective and safe the combination of fluoropyrimidines and bevacizumab is when used in daily clinical practice.
The primary objective of the study is to evaluate overall survival, while secondary endpoints include progression-free survival, response rates, safety, and identification of clinical or molecular factors that may predict outcomes. The study will include approximately 300 patients treated between 2023 and 2026. Both retrospective and prospective data will be collected, and no additional procedures, exams, or financial costs are imposed on the healthcare system. The study follows ethical guidelines laid out by the Declaration of Helsinki and has been approved by the regional ethics committee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic colorectal cancer treated with fluoropyrimidines and bevacizumab.
Key inclusion criteria (4 listed)
- Age ≥18 years;
- ECOG PS 0-2;
- Histologic diagnosis of colorectal cancer;
- Treatment with fluoropyrimidine plus bevacizumab.
Key exclusion criteria (2 listed)
- ECOG PS ≥3;
- Absence of histologic diagnosis.
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 |
|---|---|---|
| FluoropyrimidineTreatment with fluoropyrimidines and bevacizumab | Drug | – |
Primary outcome
Overall Survival
Time frame: up to 30 months from the date of treatments' start
Time from start of the treatment to death from any cause up to 30 months from the date of treatments' start.
Progression-free survival
Time frame: up to 30 months from the date of treatments' start
time from the start of the treatment to disease progression or death from any cause, whichever occurred first, up to 30 months from the date of treatments' start.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Lisa Salvatore principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer Metastatic, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall Survival (time frame: up to 30 months from the date of treatments' start). The study lists 2 primary outcomes in all. 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 27 Mar 2026.