Metastatic Colon CancerREVERTNCT05396807
REVERT - taRgeted thErapy for adVanced colorEctal canceR paTients
A study testing AI in people with Metastatic Colon Cancer, run by University of Rome Tor Vergata at 6 sites in 3 countries.
Trial summary
This is a clinical prospective, no-Profit, Interventional, Premarket Medical Device "early phase", multicentre, single-arm study, based on collecting data on predictive biomarkers of mCRC patients, integrate them with the results of the retrospective evaluation of outcomes and profiles of historical mCRC patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colon Cancer
- What is being tested?
- AI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 21 Mar 2023to 25 Nov 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated Informed Consent.
- Age ≥ 18 years at time of Informed Consent.
- Histologically- or cytologically-confirmed mCRC.
- Assessed tumour EGFR pathway mutational status (K-RAS, N-RAS), BRAF, HER-2 neu, MSI.
- Sufficient amount of representative tumour specimen (primary or metastatic, archival or newly obtained for confirmatory central laboratory testing of BRAF and KRAS mutational status.
- Dihydropyrimidine dehydrogenase (DPD) before 5-FU infusion.
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- Eligibility to receive bevacizumab, cetuximab or panitumumab per locally approved label with regard to tumour RAS status.
- Recurrence of disease after primary radical surgery and adjuvant therapy carried out > 6 months prior the present trial.
- Evidence of measurable or evaluable non-measurable disease as per RECIST, v1.1
- ECOG PS of 0 or 1.
- Adequate bone marrow function characterized by the following at screening:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
- Platelets ≥ 100 × 10^9/L;
- Haemoglobin ≥ 9.0 g/dL.
- Adequate renal function characterized by serum creatinine ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance ≥ 50 mL/min.
- Adequate hepatic function characterized by the following:
- Serum total bilirubin ≤ 1.5 × ULN and < 2 mg/dL;
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 ×ULN in presence of liver metastases.
- Female patients are either postmenopausal for at least 1 year, surgically sterile for at least 6 weeks, or must agree to take appropriate precautions to avoid pregnancy.
- Males must agree to take appropriate precautions to avoid fathering a child from screening through follow-up.
Who cannot join
- Prior hypersensitivity or toxicity to chemotherapy drugs suggesting an inability to tolerate the proposed treatment.
- Patients should not be candidate for upfront resection of metastatic disease.
- Symptomatic brain metastasis.
- Leptomeningeal disease.
- Known history of acute or chronic pancreatitis.
- History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery).
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- Impaired cardiovascular function or clinically significant cardiovascular diseases.
- Uncontrolled hypertension defined as persistent elevation of systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy.
- Impaired hepatic function, defined as Child-Pugh class B or C.
- Concurrent or previous other malignancy.
- History of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment.
- Concurrent neuromuscular disorder associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
- Known contraindication to receive antineoplastic treatment at the planned doses.
- Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study.
- Pregnancy, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test result, or lactating.
- Participation to other clinical trial studies.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Italy3 sites
Scienze della Salute Università degli Studi di Firenze
Florence, 50121
Unità Oncologia Medica Dipartimento di Discipline Chirurgiche, Oncologiche e Stomatologiche
Palermo, 90127
Medical Oncology Unit, Department of Oncohematology, Policlinico Tor Vergata
Roma, 00133
Romania2 sites
"Grigore T. Popa" University of Medicine and Pharmacy of Iași
Iași, Iaşi, 700115
Regional Institute of Oncology
Iași, Iaşi, 700483
About this study
This is a clinical prospective, no-Profit, Interventional, Premarket Medical Device "early phase", multicentre, single-arm study, based on collecting data on predictive biomarkers of mCRC patients, integrate them with the results of the retrospective evaluation of outcomes and profiles of historical mCRC patients previously treated in the Oncology Units, in order to evaluate the efficacy of the best administered treatment. Results from the retrospective evaluation, will serve to build an AI-based profile capable to identify "good" or "poor" responders to therapy and to support the clinician towards the best treatment option. AI is a software based on algorithm defined as Medical Device Class IIa.
Read the detailed description
This is a clinical prospective, no-Profit, Interventional, Premarket Medical Device "early phase", multicentre, single-arm study, based on collecting data on predictive biomarkers of mCRC patients, integrate them with the results of the retrospective evaluation of outcomes and profiles of historical mCRC patients previously treated in the Oncology Units, in order to evaluate the efficacy of the best administered treatment. Results from the retrospective evaluation, will serve to build an AI-based profile capable to identify "good" or "poor" responders to therapy and to support the clinician towards the best treatment option. Following the first disease progression (PD), 2nd line therapy will be at Investigator's choice. The drugs under investigation are those commonly employed in mCRC patients as per usual standard of care. Artificial Intelligence (AI) is a software based on algorithm defined as Medical Device Class IIa.
The REVERT clinical trial is study, inserted within a wider European Project. The clinical study will take advantage of the results of the retrospective evaluation of mCRC patients' outcomes and profiles, aimed at evaluate the efficacy of treatment strategies, that will performed during the early activities of the European Project. In such retrospective analysis AI and Machine Learning (ML) will be instructed and used to derive predictive clinical data, after having analysed all possible variables including known mutational, biochemical and clinical features of samples from mCRC patients historically treated in the Oncology Units participating to the project and stored in partner Biobanks. AI and ML methodologies are based on Support Vector Machines and combine Multiple Kernel Learning and Random Optimization, incorporating already available large databases with new, potential prognostic/predictive biomarkers (e.g., gene mutations, epigenetic changes, gene expression profiling signatures). The emerging results will be used to help the choice of the best combinatorial therapy, for every prospectively enrolled mCRC patient. Sex and gender differences, also according to sidedness, will be analysed to evaluate their impact on survival and quality of life (QoL) in patients with mCRC.
Study length is planned to be about 24 months (12 months recruitment + 12 months of follow-up). The end of study is defined as the time when all enrolled patients will have experienced evidence of disease progression or will be out of treatment as per protocol, toxicity, medical decision or patient's withdrawal.
- Conditions
- Metastatic Colon Cancer
- Being tested
- AI
- Keywords
- metastatic Colon Rectal Cancer, WT wild type, RAS
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIDevice
The aim of using AI software to support physicians in choosing the most effective treatment.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Other | mCRC subjects with WT (wild type) and RAS (matated) Receives: Device: AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression Free Survival (PFS), including PFS1 and PFS2, defined as the time from enrolment to the first documentation of objective disease progression or death due to any cause, whichever occurs first.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Overall survival (OS)
The time from enrolment to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.
Measured: through study completion, an average of 1 year
Response Rate (RR)
The percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria, during the phases of treatment.
Measured: through study completion, an average of 1 year
Early Tumour Shrinkage (ETS)
As the percentage of patients, relative to the total of the enrolled subjects, achieving a >20% decrease in the sum of diameters of RECIST target lesions.
Measured: through study completion, an average of 1 year
Quality of Life (QoL)
measured using the EORTC QLQ-C30 questionnaire
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start21 Mar 2023
- Primary completion31 Mar 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colon 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients, male and female, age ≥18 years, with WT (wild type) and RAS mutated (mut) affected by mCRC.
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Mario Roselli, University of Rome Tor Vergata
- Investigators
- Mario Roselli, PI, Principal investigator, Medical Oncology Unit, Department of Oncohematology, Policlinico Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396807
- Sponsor's protocol ID
- University Tor Vergata
- Acronym
- REVERT
- Status last verified
- Nov 2024
- First submitted
- 19 May 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVERT - taRgeted thErapy for adVanced colorEctal canceR paTients
- ClinicalTrials.gov ID
- NCT05396807
- Acronym / sponsor ID
- REVERT / University Tor Vergata
- Conditions
- Metastatic Colon Cancer
- Keywords
- metastatic Colon Rectal Cancer, WT wild type, RAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 31 May 2022 (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 is a clinical prospective, no-Profit, Interventional, Premarket Medical Device "early phase", multicentre, single-arm study, based on collecting data on predictive biomarkers of mCRC patients, integrate them with the results of the retrospective evaluation of outcomes and profiles of historical mCRC patients previously treated in the Oncology Units, in order to evaluate the efficacy of the best administered treatment. Results from the retrospective evaluation, will serve to build an AI-based profile capable to identify "good" or "poor" responders to therapy and to support the clinician towards the best treatment option. AI is a software based on algorithm defined as Medical Device Class IIa.
Detailed description
This is a clinical prospective, no-Profit, Interventional, Premarket Medical Device "early phase", multicentre, single-arm study, based on collecting data on predictive biomarkers of mCRC patients, integrate them with the results of the retrospective evaluation of outcomes and profiles of historical mCRC patients previously treated in the Oncology Units, in order to evaluate the efficacy of the best administered treatment. Results from the retrospective evaluation, will serve to build an AI-based profile capable to identify "good" or "poor" responders to therapy and to support the clinician towards the best treatment option. Following the first disease progression (PD), 2nd line therapy will be at Investigator's choice. The drugs under investigation are those commonly employed in mCRC patients as per usual standard of care. Artificial Intelligence (AI) is a software based on algorithm defined as Medical Device Class IIa.
The REVERT clinical trial is study, inserted within a wider European Project. The clinical study will take advantage of the results of the retrospective evaluation of mCRC patients' outcomes and profiles, aimed at evaluate the efficacy of treatment strategies, that will performed during the early activities of the European Project. In such retrospective analysis AI and Machine Learning (ML) will be instructed and used to derive predictive clinical data, after having analysed all possible variables including known mutational, biochemical and clinical features of samples from mCRC patients historically treated in the Oncology Units participating to the project and stored in partner Biobanks. AI and ML methodologies are based on Support Vector Machines and combine Multiple Kernel Learning and Random Optimization, incorporating already available large databases with new, potential prognostic/predictive biomarkers (e.g., gene mutations, epigenetic changes, gene expression profiling signatures). The emerging results will be used to help the choice of the best combinatorial therapy, for every prospectively enrolled mCRC patient. Sex and gender differences, also according to sidedness, will be analysed to evaluate their impact on survival and quality of life (QoL) in patients with mCRC.
Study length is planned to be about 24 months (12 months recruitment + 12 months of follow-up). The end of study is defined as the time when all enrolled patients will have experienced evidence of disease progression or will be out of treatment as per protocol, toxicity, medical decision or patient's withdrawal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients, male and female, age ≥18 years, with WT (wild type) and RAS mutated (mut) affected by mCRC.
| Arm | Type | Receives |
|---|---|---|
| All subjects | Other | Device: AImCRC subjects with WT (wild type) and RAS (matated) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Signed and dated Informed Consent.
- Age ≥ 18 years at time of Informed Consent.
- Histologically- or cytologically-confirmed mCRC.
- Assessed tumour EGFR pathway mutational status (K-RAS, N-RAS), BRAF, HER-2 neu, MSI.
- Sufficient amount of representative tumour specimen (primary or metastatic, archival or newly obtained for confirmatory central laboratory testing of BRAF and KRAS mutational status.
Key exclusion criteria (16 listed)
- Prior hypersensitivity or toxicity to chemotherapy drugs suggesting an inability to tolerate the proposed treatment.
- Patients should not be candidate for upfront resection of metastatic disease.
- Symptomatic brain metastasis.
- Leptomeningeal disease.
- Known history of acute or chronic pancreatitis.
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 |
|---|---|---|
| AIThe aim of using AI software to support physicians in choosing the most effective treatment. | Device | All subjects |
Primary outcome
Progression Free Survival (PFS)
Time frame: through study completion, an average of 1 year
Progression Free Survival (PFS), including PFS1 and PFS2, defined as the time from enrolment to the first documentation of objective disease progression or death due to any cause, whichever occurs first.
4 secondary outcomes
Overall survival (OS)
Time frame: through study completion, an average of 1 year
Response Rate (RR)
Time frame: through study completion, an average of 1 year
Early Tumour Shrinkage (ETS)
Time frame: through study completion, an average of 1 year
Quality of Life (QoL)
Time frame: through study completion, an average of 1 year
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 29 Nov 2024.
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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.
Mario Roselli, PI principal investigator
Medical Oncology Unit, Department of Oncohematology, Policlinico Tor Vergata
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI in people with Metastatic Colon Cancer, run by University of Rome Tor Vergata at 6 sites in 3 countries.
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 20 inclusion and 16 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 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Romania, Spain. 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 (PFS) (time frame: through study completion, an average of 1 year). 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 29 Nov 2024.