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Partial Liver Segment 2/3 Transplantation Study

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ClinicalTrials.gov Identifier: NCT02215889
Recruitment Status : Recruiting
First Posted : August 13, 2014
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Svein Dueland, Oslo University Hospital

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, the remaining liver segments of the recipient are removed. The patient will at this time have only donor liver tissue in place.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Liver transplantation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Clinical Trial to Evaluate the Benefit and Efficacy of Liver Resection And Partial Liver Segment 2/3 Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Liver Metastases From ColoRectal Carcinoma
Study Start Date : June 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2028

Arm Intervention/treatment
Experimental: Surgery Procedure: Liver transplantation



Primary Outcome Measures :
  1. Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215889


Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424 Oslo
Contact: Svein Dueland, MD,Ph.D.    22935789 ext +47    svedue@ous-hf.no   
Principal Investigator: Svein Dueland, MD, Ph.D.         
Sponsors and Collaborators
Oslo University Hospital

Responsible Party: Svein Dueland, M.D, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02215889     History of Changes
Other Study ID Numbers: RAPID 2014
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

Keywords provided by Svein Dueland, Oslo University Hospital:
Liver metastases
Transplantation

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Extracts
Hematinics