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Partial Liver Segment 2/3 Transplantation Study

Primary Purpose

Colorectal Cancer

Status

Recruiting

Phase

Phase 1

Locations

Norway

Study Type

Interventional

Intervention

Liver transplantation

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Liver metastases, Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgery

Arm Description

Outcomes

Primary Outcome Measures

Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation.

Secondary Outcome Measures

Overall Survival

Full Information

NCT ID

NCT02215889

First Posted

June 24, 2014

Last Updated

October 4, 2022

Sponsor

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02215889

Brief Title

Partial Liver Segment 2/3 Transplantation Study

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 Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 2014 (undefined)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

Liver metastases, Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgery

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Liver transplantation

Primary Outcome Measure Information:

Title

Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Overall Survival

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Magnus Smedman, MD

Phone

23026600

torha@ous-hf.no

Facility Information:

Facility Name

Oslo University Hospital

City

Oslo

ZIP/Postal Code

0424 Oslo

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Magnus Smedman, MD

Phone

23026600

Ext

+47

torha@ous-hf.no

First Name & Middle Initial & Last Name & Degree

Magnus Smedman, MD

12. IPD Sharing Statement

Learn more about this trial

Partial Liver Segment 2/3 Transplantation Study

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