Status:
RECRUITING
Partial Liver Segment 2/3 Transplantation Study
Lead Sponsor:
Oslo University Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The patients will receive hepatectomy as a 2 stage procedure. In the first surgical procedure liver segments 2-3 are removed and liver donor segments 2-3 inserted. After growth of donor segments 2-3, ...
Eligibility Criteria
Inclusion
- 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 4 weeks prior to the faculty meeting at the transplant unit, except patients may have 1-3 resectable lung lesions all\<15mm.
- No signs of extra hepatic metastatic disease on CT thorax/abdomen/pelvis within 4 weeks prior to the faculty meeting at the transplant unit, except patients may have 1-3 resectable lung lesions all\<15mm.
- No local recurrence according to MR-pelvis scan in patients with rectal cancer within 4 weeks prior to the faculty meeting at the transplant unit
- No signs of local recurrence judged by colonoscopy / CT colography within 12 months prior to the faculty meeting at the transplant unit
- Good performance status, ECOG 0 or 1.
- Satisfactory blood tests: Hb \>10g/dl, neutrophiles \>1.0 (after any G-CSF), TRC \>75, Bilirubin\<2 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 follow up must be obtained and documented according to GCP, and national/local regulations.
- All patients should have received at least 8 weeks of chemotherapy.
Exclusion
- Weight loss \>10% the last 6 months
- Patient BMI \> 30
- Previous diagnosed bone or CNS metastatic disease.
- Previous diagnosed cancer mammae or malignant melanoma.
- Palliative resection of primary CRC tumor.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02215889
Start Date
June 1 2014
End Date
June 1 2028
Last Update
February 6 2024
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, 0424 Oslo