Actively Recruiting
Liver Transplantation and Colorectal Cancer
Led by Oslo University Hospital · Updated on 2024-02-07
25
Participants Needed
1
Research Sites
816 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Colorectal liver metastases (CLM) are currently considered an absolute contraindication for liver transplantation (Lt) although Lt for other primary and secondary liver malignancies show excellent outcome in selected patients. Before 1995, several Lts for CLM were performed, but the outcome was poor (18% 5-year survival) and Lt for CLM was stopped. Since then, several advances have been achieved and survival following Lt has improved by almost 30%. Thus, a 5-year survival of about 50% following Lt for CLM could be anticipated. The investigators have previously included 21 patients in a pilot study. All patients had advanced CLM at the time of Lt. Long term overall survival (OS) exceeds by far previously reported outcome for this patient group and is comparable or better than survival following repeat Lt for non-malignant diagnoses. Development of robust selection criteria may further improve the results. The investigators will conduct a randomized controlled trial to explore whether liver transplantation in selected patients with liver metastases from CRC can obtain significant life extension and better health related quality of life compared to patients receiving surgical resection. The investigators will also explore if patient selection according to nomo-grams for outcome of colorectal cancer can define a subgroup of patients with a 5 year survival of at least 50% or even cure from the disease.
CONDITIONS
Official Title
Liver Transplantation and Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma in colon or rectum
- No signs of metastatic disease outside the liver or local tumor recurrence based on recent PET/CT, CT, or MR scans
- No local recurrence confirmed by colonoscopy or CT colography within the past 12 months
- Good performance status (ECOG 0 or 1)
- Adequate blood test results including hemoglobin above 10 g/dl, neutrophils over 1.0, platelets over 75, bilirubin less than twice the upper normal limit, liver enzymes within five times the upper limit, creatinine under 1.25 times normal, and albumin above lower normal level
- Standard surgical removal with sufficient tumor-free margins for rectal cancer
- Signed informed consent and willingness to comply with treatment and follow-up
- Received at least 3 cycles of chemotherapy with no tumor enlargement according to RECIST criteria
- For part A: Six or more technically resectable liver metastases
- For part B: Metachronous liver metastases occurring more than 12 months after CRC diagnosis or adjuvant treatment, pN0 tumor classification, carcinoembryonic antigen (CEA) under 100 ng/ml at diagnosis and metastasis, liver metastases not eligible for curative resection, no lesions larger than 10 cm, 20 or fewer lesions total, at least 10% tumor response to first-line chemotherapy, and acceptance for transplantation before disease progression
- For part C: Liver metastases not eligible for curative resection, received first-line treatment, no lesions larger than 10 cm, 20 or fewer lesions total, at least 10% tumor response to second- or third-line chemotherapy, acceptance for transplantation before disease progression, and at least two years since CRC diagnosis before listing
- For Arm D: Expected survival of 6-12 months without transplantation, possible inclusion without further chemotherapy, resectable lung lesions allowed
You will not qualify if you...
- Weight loss over 10% in the past 6 months
- Body mass index (BMI) over 30
- Other malignancies
- Prior metastatic disease outside the liver or local tumor relapse
- Lack of standard pre-, peri-, or post-operative treatment for primary colorectal cancer
- Palliative surgery for primary colorectal cancer
- Previous participation in this trial
- Any condition that in the investigator's opinion prevents participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway, 0451
Actively Recruiting
Research Team
M
Magnus Smedman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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