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Embolization for Small Future Liver Remnant in Colorectal Cancer (DRAGON 2 Trial)
N/A
Recruiting
Led By Ronald M. van Dam, PhD
Research Sponsored by Maastricht University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with primarily unresectable/potentially resectable CRLM with a FLR <30% (<40% in chemotherapy damaged livers)
18 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
DRAGON 2 Trial Summary
This trial will study if adding a second vaccine helps protect people against SARS-CoV-2.
Who is the study for?
The DRAGON 2 trial is for adults with colorectal liver metastases (CRLM) where the remaining healthy liver is too small for safe surgery. Candidates must have potentially resectable or treatable lung/brain metastases and not be pregnant, breastfeeding, or unwilling to use contraception. Those with disease progression after chemotherapy or other hepatic malignancies are excluded.Check my eligibility
What is being tested?
This study compares two procedures in patients needing more healthy liver tissue before cancer surgery: Portal Vein Embolization (PVE), which redirects blood to grow healthy liver areas, and a combination of PVE with Hepatic Vein Embolization (HVE). Participants are randomly assigned to one of these two groups.See study design
What are the potential side effects?
Embolization can cause pain at the injection site, fever, nausea, and fatigue. Rarely it may lead to complications like infection or allergic reactions to materials used during the procedure. Liver function might also temporarily worsen.
DRAGON 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver cancer can't be removed by surgery due to its size or my liver's condition.
Select...
I am 18 years old or older.
DRAGON 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
5-year Overall Survival
Embolization, Therapeutic
Side effects data
From 2012 Phase 2 trial • 53 Patients • NCT0066162285%
Increased SGPT
85%
Increased SGOT
81%
Pain
65%
Nausea
62%
Decreased hemoglobin
42%
Fatigue
35%
Fever
35%
Increased alkaline phosphatase
31%
Leukopenia
27%
Vomiting
23%
Thrombocytopenia
19%
Constipation
15%
Anorexia
15%
Rash
15%
Chills/rigors
12%
Diarrhea
12%
Dyspnea
12%
Dizziness
12%
Hypotension
8%
Anxiety
8%
Decreased WBC
8%
Elevated liver enzymes
8%
Flatulence
8%
Night sweats
8%
Increased creatinine
8%
Bruising
8%
Increased bilirubin
8%
Decreased granulocytes
4%
Blurred vision
4%
Diaphoresis
4%
Bradycardia
4%
Flu
4%
Bruising at cath site
4%
Aneurysms
4%
Bloating
4%
Hyperglycemia
4%
Bleeding at procedure site
4%
Sinus pain
4%
Agitation
4%
Pneumonitis
4%
Insomnia
4%
Sinus allergies
4%
Lymphpenia
4%
Lethargy
4%
Sensitivity to heat
4%
Hypertension
4%
Bleeding
4%
Tachycardia
4%
Dysgeusia
4%
Heart palpitations
4%
Hoarseness
4%
Hypoalbuminemia
4%
Headache
4%
Neutropenia
4%
Cold
4%
Cough
4%
Slurred speech
4%
Disequilibrium
4%
Irritation
4%
Belching
100%
80%
60%
40%
20%
0%
Study treatment Arm
Immunoembolization
Plain Embolization
DRAGON 2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)Experimental Treatment1 Intervention
Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
Group II: Portal Vein Embolization (PVE) alone - (control arm)Active Control1 Intervention
Portal Vein Embolization (PVE) alone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Embolization
2004
Completed Phase 3
~930
Find a Location
Who is running the clinical trial?
Maastricht UniversityLead Sponsor
234 Previous Clinical Trials
13,180,055 Total Patients Enrolled
Ronald M. van Dam, PhDPrincipal InvestigatorMaastricht Universitair Medisch Centrum
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver's shape or tumor location prevents certain liver vein treatments.I am a premenopausal woman not using or willing to use birth control pills.My liver cancer can't be removed by surgery due to its size or my liver's condition.My cancer fully responded to the initial chemotherapy.My lung or brain cancer can be surgically removed or treated, as confirmed by a tumor board.I am 18 years old or older.My scans show cancer outside the liver that can't be surgically removed.I am either a man or a woman.My cancer has grown despite chemotherapy.My cancer outside the liver cannot be surgically removed or destroyed.My colorectal cancer has not been surgically removed, but there are plans to do so.I have liver cancer that is not colorectal liver metastases.
Research Study Groups:
This trial has the following groups:- Group 1: Portal Vein Embolization (PVE) alone - (control arm)
- Group 2: Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what capacity is this trial being implemented in healthcare facilities?
"19 distinct medical facilities are authorized to conduct this trial, including Maxima Medisch Centrum in Eindhoven, Monash Medical Centre in Clayton, and Social Medical Center South located in Vienna."
Answered by AI
Are any new participants being accepted into this research endeavor?
"Yes, the information on clinicaltrials.gov affirms that this trial is actively enrolling participants. This research project was initially advertised in April of 2022 and has been regularly updated since then - most recently on July 24th 2023."
Answered by AI
How many individuals are taking part in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical trial is still recruiting patients and was first listed on April 1st 2022 with a most recent update occurring July 24th 2023. The study aims to enroll 348 individuals across 19 different healthcare facilities."
Answered by AI
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