Actively Recruiting
Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer
Led by Oslo University Hospital · Updated on 2024-02-06
30
Participants Needed
1
Research Sites
525 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial is a randomized control trial. Patients are randomized between Ltx and other treatment that may include further chemotherapy, TACE, SIRT or other available treatment options. The patients will be randomized 1:1 to Ltx and chemotherapy/other treatment options.
CONDITIONS
Official Title
Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically verified adenocarcinoma in colon or rectum
- Liver metastases that cannot be surgically removed
- No signs of cancer outside the liver or local recurrence on PET/CT scan within 6 weeks before transplant evaluation, except resectable lung lesions all under 15mm
- No signs of cancer outside the liver on CT or MRI of thorax, abdomen, and pelvis within 6 weeks before transplant evaluation, except resectable lung lesions all under 15mm
- Good performance status, ECOG 0 or 1
- Blood tests showing hemoglobin over 10 g/dl, neutrophils over 1.0 (after any G-CSF), platelets over 75, bilirubin less than 1.5 times upper normal level, ASAT and ALAT less than 5 times upper normal level, creatinine less than 1.25 times upper normal level, and albumin above lower normal level
- Signed informed consent and expected cooperation for treatment and follow-up
- Progressive disease by RECIST criteria or intolerance to first-line chemotherapy
- Randomization before evaluation 8-12 weeks after starting second-line chemotherapy
You will not qualify if you...
- Weight loss greater than 10% in the last 6 months
- Body mass index over 30
- Previous surgery for local relapse or non-liver metastasis within last 2 years, or surgery of pulmonary or liver hilum lymph node metastases within last year
- Previous diagnosis of bone or central nervous system metastases or metastatic lymph nodes in thorax or abdomen
- Previous diagnosis of breast cancer or malignant melanoma
- Non-resected or palliative resection of primary colorectal tumor
- Liver metastases affecting the diaphragm as seen on CT or ultrasound
- Liver lesion larger than 10 cm
- Having three negative prognostic factors at randomization (CEA over 80, less than 2 years from diagnosis, largest liver lesion over 5.5 cm)
- Any condition that the investigator believes makes participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway
Actively Recruiting
Research Team
M
Magnus Smedman, MD
CONTACT
M
Maria Gjerde
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here