Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer

NCT03494946 | Recruiting

• 1 other identifier: 2016/1657 SECAIII
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Metastases; Colorectal Cancer

Keywords

Liver metastasis; Colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm A

EXPERIMENTAL

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

Procedure: Liver transplantation

Arm B

ACTIVE COMPARATOR

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

Interventions

Liver transplantation PROCEDURE

Arm A

Chemotherapy DRUG

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

Also known as: Other treatment

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Liver Transplantation; Drug Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Magnus Smedman, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magnus Smedman, MD

CONTACT

23026600; torha@ous-hf.no

Maria Gjerde

CONTACT

+4723070000; mgjerde@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, gastrointestinal oncology

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

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: December 5, 2016
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

NO (1)