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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Liver Metastases
• Intervention / Treatment: Procedure: Liver transplantation; Drug: Chemotherapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magnus Smedman, MD; Phone Number: 23026600; Email: torha@ous-hf.no
• Study Contact Backup: Name: Maria Gjerde; Phone Number: +4723070000; Email: mgjerde@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital
    • Contact: Magnus Smedman, MD; Phone Number: +47 23026600; Email: torha@ous-hf.no
    • Contact: Maria Gjerde; Phone Number: +4723070000; Email: mgjerde@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Patients that suffer from Colorectal cancer and metastasis to liver that are randomized to Group A, will undergo Liver transplantation	Procedure: Liver transplantation
Active Comparator: 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.	Drug: Chemotherapy; May include chemotherapy, TACE, SIRT or other available treatment options.; Other Names: Other treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years from time of randomisation

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Magnus Smedman, MD, Oslo University Hospital

Publications and helpful links

Helpful Links

• European Liver Transplant registry

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2016
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Colorectal cancer; Liver metastasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: 2016/1657 SECAIII

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No