Testing Floxuridine for colorectal adenocarcinoma metastatic in the liver
Official title: Hepatic Arterial Infusion Chemotherapy in Patients With Inoperable Colorectal Cancer Liver Metastasis
A Phase II Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Best Systemic Chemotherapy in Patients With Inoperable Hepatic Metastasis From Colorectal Cancer
Interventions
Floxuridine (FUDR)
Floxuridine will be administered at a recommended dose of 0.12 mg/kg/day and adjusted as per participants weight and lab results.
Canadian Sites (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for27 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 18 years.
- +The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist. In the event that two hepatobiliary surgeons cannot agree, a third surgeon will be consulted. Continued discrepancy will result in the patient's case being presented at weekly hepatobiliary conference for consensus opinion. Inoperable metastases are defined as: requiring a resection that leaves less than 2 hepatic segments (not including the caudate lobe) behind with adequate arterial/portal inflow, venous outflow and biliary drainage. \* A patient is considered resectable if the procedure includes a minor wedge or thermo-ablation encompassing 10% or less of the volume of the remaining 2 segments.
- +History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. Patients with resectable or ablatable lung metastasis are eligible.
- +Physically able to tolerate major partial hepatectomy.
- +The primary tumor may be in place at the time of registration if not obstructing the intestinal lumen or significantly bleeding. If present, the primary tumor will be resected at the time of pump placement.
- +Chest, Abdominal and Pelvic CT scan with CT angiogram within 6 weeks prior to registration. (MRI angiogram with contrast of the abdomen may be substituted for CT of the abdomen).
- +Patient's liver metastases must comprise \<70% of the liver parenchyma.
- +ECOG PS \< 2.
- +Within 14 days of registration: o WBC \>3X10E9/L; ANC ≥ 1.5X10E9/L; Platelet count \>100X10E9/L; INR \< 1.5; HGB ≥ 90 g/L; Estimated creatinine clearance ≥30 ml/min (using Cockcroft and Gault formula); Total serum bilirubin \<25.6 umol/L.
- +Signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- +Patients with limited/responding lung metastases on Physician's discretion.
- +Female patients of child-bearing age must undergo a pregnancy test and have a negative result.
- +A patient must have had prior chemotherapy.
Exclusion
- −Patient may not have received prior treatment with FUDR.
- −Active infection, ascites, hepatic encephalopathy.
- −Active concurrent malignancies, except a patient's potentially resectable colorectal primary.
- −Extrahepatic metastases except for resectable or ablatable lung metastasis.
- −Patient must not have obstruction of GI or GU tract.
- −Patients may not be receiving any other investigational agents.
- −Patients with history of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke will also be excluded (history of stroke or transient ischemic attack within 6 months prior to Day 1).
- −Serious or non-healing active wound, ulcer, or bone fracture.
- −Chronic daily treatment with aspirin (\> 325 mg/d) or nonsteroidal anti- inflammatory medications known to inhibit the platelet function.
- −Presence of bleeding diathesis or coagulopathy.
- −History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure of \> 150/100 mmHg on medication), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e. atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or peripheral vascular disease (Grade II or greater).
- −Female patients who are pregnant or lactating.
- −Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration).
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: Floxuridine (FUDR).
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 200 people.
The study is currently expected to finish around December 2036.
The main measurement is taken over: From time of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to approximately 42 days from last treatment with hepatic artery infusion pump therapy.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Proportion of participants that undergo liver resection following treatment with FUDR — measured over From time of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to approximately 42 days from last treatment with hepatic artery infusion pump therapy.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07764497 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Floxuridine (FUDR)Drug
Floxuridine will be administered at a recommended dose of 0.12 mg/kg/day and adjusted as per participants weight and lab results.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From time of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to approximately 42 days from last treatment with hepatic artery infusion pump therapy..
The study as a whole is currently expected to finish around 2036-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 200 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of this clinical trial is to assess how many patients with initially inoperable colorectal liver metastasis are able to have a liver surgery after treatment with hepatic artery infusion chemotherapy and standard of care systemic chemotherapy.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.