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Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer (SECAIII)

Primary Purpose

Liver Metastases, Colorectal Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Liver transplantation

Chemotherapy

About this trial

This is an interventional treatment trial for Liver Metastases focused on measuring Liver metastasis, Colorectal cancer

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 6 weeks prior to the faculty meeting at the transplant unit, except patients may have resectable lung lesions all < 15mm.
No signs of extra hepatic metastatic disease on CT or MRI thorax/abdomen/pelvis within 6 weeks prior to the faculty meeting at the transplant unit, except resectable lung lesions all < 15mm.
No signs of extra hepatic metastatic disease on PET/CT within 6 weeks prior to the faculty meeting at the transplant unit, except patients may have resectable lung lesions all < 15mm
Good performance status, ECOG 0 or 1.
Satisfactory blood tests Hb >10g/dl, neutrophiles >1.0 (after any G-CSF), TRC >75, Bilirubin<1.5 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 followup must be obtained and documented according to GCP, and national/local regulations.
All patients should have progressive disease according to RECIST-criteria, or intolerance to 1. line chemotherapy. Patients must be randomized before evaluation 8-12 weeks after starting 2. line chemotherapy.

Exclusion Criteria:

Weight loss >10% the last 6 months
Patient BMI > 30
Previous resection of local relapse or non-hepatic metastasis within the last 2 years or resection of pulmonary or liver hilus lymph node metastases the last year.
Previous diagnosed bone or CNS metastatic disease or thoracic or abdominal metastatic lymph nodes.
Previous diagnosed cancer mammae or malignant melanoma.
Non resected or palliative resection of primary CRC tumor.
Liver metastases affecting the diaphragm determined by CT-scan and/or ultrasound examination.
Liver lesion>10cm
Three negative prognostic factors at time of randomization (CEA>80, less than 2 years from diagnosis, diameter of largest liver lesion >5.5cm).
Any reason why, in the opinion of the investigator, the patient should not participate.

Sites / Locations

Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Patients that suffer from Colorectal cancer and metastasis to liver that are randomized to Group A, will undergo Liver transplantation

Patients that suffer from Colorectal cancer and metastasis to liver that are randomized to Group B, will be given chemotherapy, TACE, SIRT or other available treatment options.

Outcomes

Primary Outcome Measures

Overall Survival

To determine overall survival after Ltx compared to palliative chemotherapy/other treatment in patients with progressive disease on chemotherapy or intolerance to 1-line chemotherapy.

Secondary Outcome Measures

Full Information

NCT ID

NCT03494946

First Posted

April 4, 2018

Last Updated

October 4, 2022

Sponsor

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03494946

Brief Title

Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer

Acronym

SECAIII

Official Title

A Randomized Clinical Trial Comparing Overall Survival in Selected Patients With ColoRectal Carcinoma Treated by Liver Transplantation or Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 5, 2016 (Actual)

Primary Completion Date

January 2027 (Anticipated)

Study Completion Date

January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

Patients with non-resectable CRC liver metastases evaluated at the liver MDT at Oslo University Hospital, Rikshospitalet will be included in the study. Patients should have progressive disease on 1.line chemotherapy or the treatment should have been stopped due to toxicity. Patients randomized to Ltx will if applicable stop bevazicumab. All patients (both arms) will start further treatment that may include chemotherapy, TACE, SIRT or other available treatment options. Patients not receiving a donor liver graft within 3 months after listing for transplantation will be taken off the waiting list and transferred to the chemotherapy/other treatment option group. Patients randomized to Ltx and developing progressive disease beyond the inclusion/exclusion criteria during the time on the waiting list will be excluded from the study and receive best treatment option at the discretion of the treating physician.

6. Conditions and Keywords

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

Liver Metastases, Colorectal Cancer

Keywords

Liver metastasis, Colorectal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A randomized study were half of the subjects will be given standard chemo therapy and the other half will undergo liver transplantation.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Patients that suffer from Colorectal cancer and metastasis to liver that are randomized to Group A, will undergo Liver transplantation

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

Patients that suffer from Colorectal cancer and metastasis to liver that are randomized to Group B, will be given chemotherapy, TACE, SIRT or other available treatment options.

Intervention Type

Procedure

Intervention Name(s)

Liver transplantation

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Other Intervention Name(s)

Other treatment

Intervention Description

May include chemotherapy, TACE, SIRT or other available treatment options.

Primary Outcome Measure Information:

Title

Overall Survival

Description

To determine overall survival after Ltx compared to palliative chemotherapy/other treatment in patients with progressive disease on chemotherapy or intolerance to 1-line chemotherapy.

Time Frame

2 years from time of randomisation

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 6 weeks prior to the faculty meeting at the transplant unit, except patients may have resectable lung lesions all < 15mm. No signs of extra hepatic metastatic disease on CT or MRI thorax/abdomen/pelvis within 6 weeks prior to the faculty meeting at the transplant unit, except resectable lung lesions all < 15mm. No signs of extra hepatic metastatic disease on PET/CT within 6 weeks prior to the faculty meeting at the transplant unit, except patients may have resectable lung lesions all < 15mm Good performance status, ECOG 0 or 1. Satisfactory blood tests Hb >10g/dl, neutrophiles >1.0 (after any G-CSF), TRC >75, Bilirubin<1.5 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 followup must be obtained and documented according to GCP, and national/local regulations. All patients should have progressive disease according to RECIST-criteria, or intolerance to 1. line chemotherapy. Patients must be randomized before evaluation 8-12 weeks after starting 2. line chemotherapy. Exclusion Criteria: Weight loss >10% the last 6 months Patient BMI > 30 Previous resection of local relapse or non-hepatic metastasis within the last 2 years or resection of pulmonary or liver hilus lymph node metastases the last year. Previous diagnosed bone or CNS metastatic disease or thoracic or abdominal metastatic lymph nodes. Previous diagnosed cancer mammae or malignant melanoma. Non resected or palliative resection of primary CRC tumor. Liver metastases affecting the diaphragm determined by CT-scan and/or ultrasound examination. Liver lesion>10cm Three negative prognostic factors at time of randomization (CEA>80, less than 2 years from diagnosis, diameter of largest liver lesion >5.5cm). Any reason why, in the opinion of the investigator, the patient should not participate.

Central Contact Person:

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

Magnus Smedman, MD

Phone

23026600

torha@ous-hf.no

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

Maria Gjerde

Phone

+4723070000

mgjerde@ous-hf.no

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Magnus Smedman, MD

Organizational Affiliation

Oslo University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oslo University Hospital

City

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

Maria Gjerde

Phone

+4723070000

mgjerde@ous-hf.no

12. IPD Sharing Statement

Links:

URL

http://www.eltr.org

Description

European Liver Transplant registry

Learn more about this trial

Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer

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