No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
348 (estimated)
Sponsor
Maastricht University · Other
Who this trial is looking for
This trial is looking for patients with colorectal cancer that has spread to the liver. Participants will be placed in one of two groups to receive different treatments involving liver procedures.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I have colorectal cancer with liver metastases and a small future liver remnant
I can understand the trial and give informed consent
I have non-resected primary colorectal cancer with plans for surgery after liver treatment
I have lung or brain metastases that can be treated if approved by a tumor board
You may not be able to join if
I am pregnant or breastfeeding
I cannot commit to oral contraception if I am premenopausal
I have serious health problems that prevent me from participating
I have extrahepatic disease that cannot be treated
I have liver cancer that is not colorectal in origin
My disease has worsened after chemotherapy
I have a complete response after conversion chemotherapy
Tests show that I have non-resectable extrahepatic disease or unsuitable liver anatomy
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Patients with primarily unresectable/ potentially resectable CRLM with a FLR \<30% (\<40% in chemotherapy damaged livers)
* Patients with non-resected primary CRC may be included if there is an intention to resect the CRC after the liver treatment (liver first approach) or sim…
Inclusion Criteria:
* Patients with primarily unresectable/ potentially resectable CRLM with a FLR \<30% (\<40% in chemotherapy damaged livers)
* Patients with non-resected primary CRC may be included if there is an intention to resect the CRC after the liver treatment (liver first approach) or simultaneously during one of the liver procedures.
* Patients with resectable or ablatable lung or brain metastases can be included (statement about the resectability of these extrahepatic metastases by a tumor board needs to be available)
* 18 Years and older
* Men and women
* Able to understand the trial and provide informed consent.
Exclusion Criteria:
* Pregnant or lactating female.
* Premenopausal females not able or willing to commit to oral contraception
* Patients with prohibitive comorbidities, decision made by local team
* Any patient with non-resectable or non-ablatable extrahepatic disease
* Patients with hepatic malignancies other than CRLM
* Progression of disease by RECIST criteria after cytoreduction chemotherapy
* Complete response after conversion chemotherapy
* Staging CT and (if indicated) CT/MRI brain that demonstrates non-resectable extrahepatic disease
* The anatomy of the liver or manifestation of tumors in relation to the liver veins prohibits the use of combined PVE/HVE.
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