Comparing liver transplantation to chemotherapy for colorectal cancer patients with liver metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial is a randomized control trial that evaluates the effectiveness of liver transplantation (Ltx) versus chemotherapy and other treatment options in patients with non-resectable colorectal cancer liver metastases. Patients will be randomly assigned to either the Ltx group or the chemotherapy group, with the latter potentially receiving treatments such as TACE or SIRT. The study aims to include patients who have shown progressive disease on first-line chemotherapy or have stopped treatment due to toxicity. Those in the Ltx group will be monitored for eligibility and may be removed from the waiting list if they do not receive a donor liver graft within three months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically verified adenocarcinoma in colon/rectum.
* Liver metastases, not amenable to liver resection
* No signs of extra hepatic metastatic disease or local recurrence according to PET/CT scan within 6 weeks prior to the faculty meeting at the transplant unit, except patients may have resectable lung lesions all \< 15mm.
* No signs of extra hepatic metastatic disease on CT or MRI thorax/abdomen/pelvis within 6 weeks prior to the faculty meeting at the transplant unit, except resectable lung lesions all \< 15mm.
* No signs of extra hepatic metastatic disease on PET/CT within 6 weeks prior to the faculty meeting at the transplant unit, except patients may have resectable lung lesions all \< 15mm
* Good performance status, ECOG 0 or 1.
* Satisfactory blood tests Hb \>10g/dl, neutrophiles \>1.0 (after any G-CSF), TRC \>75, Bilirubin\<1.5 x upper normal level, ASAT, ALAT\<5 x upper normal level, Creatinine \<1.25 x upper normal level. Albumin above lower normal level.
* Signed informed consent and expected cooperation of the patients for the treatment and followup must be obtained and documented according to GCP, and national/local regulations.
* All patients should have progressive disease according to RECIST-criteria, or intolerance to 1. line chemotherapy. Patients must be randomized before evaluation 8-12 weeks after starting 2. line chemotherapy.

Exclusion Criteria:

* Weight loss \>10% the last 6 months
* Patient BMI \> 30
* Previous resection of local relapse or non-hepatic metastasis within the last 2 years or resection of pulmonary or liver hilus lymph node metastases the last year.
* Previous diagnosed bone or CNS metastatic disease or thoracic or abdominal metastatic lymph nodes.
* Previous diagnosed cancer mammae or malignant melanoma.
* Non resected or palliative resection of primary CRC tumor.
* Liver metastases affecting the diaphragm determined by CT-scan and/or ultrasound examination.
* Liver lesion\>10cm
* Three negative prognostic factors at time of randomization (CEA\>80, less than 2 years from diagnosis, diameter of largest liver lesion \>5.5cm).
* Any reason why, in the opinion of the investigator, the patient should not participate.

Where it's running

• Oslo University Hospital
  Oslo, Norway Recruiting

Study contacts

• Principal investigator: Magnus Smedman, MD — Oslo University Hospital
• Study coordinator: Magnus Smedman, MD
• Email: torha@ous-hf.no
• Phone: 23026600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.