Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer

NCT ID: NCT03494946

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-05
• Study Completion Date: 2027-01-31

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.

Conditions

Liver Metastases; Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

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

Group Type: EXPERIMENTAL

Liver transplantation

Intervention Type: PROCEDURE

Arm B

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.

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: DRUG

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

Interventions

Liver transplantation

Intervention Type: PROCEDURE

Chemotherapy

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

Intervention Type: DRUG

Other Intervention Names

Other treatment

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Magnus Smedman, MD

Consultant, gastrointestinal oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magnus Smedman, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Magnus Smedman, MD

Role: CONTACT

torha@ous-hf.no

23026600

Maria Gjerde

Role: CONTACT

mgjerde@ous-hf.no

+4723070000

Facility Contacts

Magnus Smedman, MD

Role: primary

torha@ous-hf.no

23026600 ext. +47

Maria Gjerde

Role: backup

mgjerde@ous-hf.no

+4723070000

Other Identifiers

2016/1657 SECAIII

Identifier Type: -

Identifier Source: org_study_id