Liver Transplantation and Colorectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01479608
First received: November 22, 2011
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

Colorectal liver metastases (CLM) are currently considered an absolute contraindication for liver transplantation (Lt) although Lt for other primary and secondary liver malignancies show excellent outcome in selected patients. Before 1995, several Lts for CLM were performed, but the outcome was poor (18% 5-year survival) and Lt for CLM was stopped. Since then, several advances have been achieved and survival following Lt has improved by almost 30%. Thus, a 5-year survival of about 50% following Lt for CLM could be anticipated.

The investigators have previously included 21 patients in a pilot study. All patients had advanced CLM at the time of Lt. Long term overall survival (OS) exceeds by far previously reported outcome for this patient group and is comparable or better than survival following repeat Lt for non-malignant diagnoses. Development of robust selection criteria may further improve the results.

The investigators will conduct a randomized controlled trial to explore whether liver transplantation in selected patients with liver metastases from CRC can obtain significant life extension and better health related quality of life compared to patients receiving surgical resection.

The investigators will also explore if patient selection according to nomo-grams for outcome of colorectal cancer can define a subgroup of patients with a 5 year survival of at least 50% or even cure from the disease.


Condition Intervention Phase
Colorectal Cancer
Liver Metastasis
Procedure: Liver transplantation and liver resection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial to Evaluate the Benefit and Efficacy of Liver Transplantation as Treatment for Selected Patients With Liver Metastases From ColoRectal Carcinoma

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Overall survival

Study Start Date: November 2011
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Histologically verified adenocarcinoma in colon or rectum.
  • No signs of extra hepatic metastatic disease or local recurrence according to PET/CT scan.
  • No signs of extra hepatic metastatic disease or local recurrence according to CT or MR (thorax/abdomen/pelvis) scan 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.
  • Standard surgical procedure with adequate resection margins including circumferential resection margins (CRM) of at least ≥2mm for rectal cancer patients.
  • 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.
  • Received at least 3 cycles of chemotherapy (6 weeks of treatment), with no increase in size of the lesions according to RECIST-criteria

Additional inclusion criteria for patients included in part A:

- Six or more liver metastases technically resectable

Additional inclusion criteria for patients included in part B:

  • Metachronous liver metastases (more than 12 months from diagnosis of CRC and/or end of adjuvant treatment)
  • Pathological classification of primary tumor as pN0 disease.
  • CEA<100 ng/ml at time of primary diagnosis as well as at time of diagnosis of metastatic disease.
  • Liver metastases not eligible for curative liver resection.
  • Before start of 1. line chemotherapy, no lesion should be larger than 10 cm and total number of lesions should be 20 or less.
  • At least 10% response (RECIST-criteria) on 1. line chemotherapy. Patients must be accepted for transplantation before progressive disease on 1. line chemotherapy.

Additional inclusion criteria for patients included in part C:

  • Liver metastases not eligible for curative liver resection.
  • Received 1.line treatment.
  • Before start of 2. or 3. line chemotherapy, no lesion should be larger than 10 cm and total number of lesions should be 20 or less.
  • At least 10% response (RECIST-criteria) on 2. or 3. line chemotherapy. Patients must be accepted for transplantation before progressive disease on 2. or 3. line chemotherapy.
  • Two years or more time span from the CRC diagnosis and date of being listed on the transplantation list.

Exclusion Criteria:

  • Weight loss >10% the last 6 months
  • Patient BMI > 30
  • Other malignancies
  • Prior extra hepatic metastatic disease or local relapse.
  • Patients who have not received standard pre-operative, per-operative or post-operative treatment for the primary CRC.
  • Palliative resection of primary CRC tumor.
  • Previous randomization in this trial.
  • Any reason why, in the opinion of the investigator, the patient should not participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479608

Contacts
Contact: Svein Dueland, MD 22934000 ext 47 svein.dueland@ous-hf.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Montebello, Norway, 0310
Contact: Svein Dueland, MD    22934000 ext 47    svein.dueland@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
  More Information

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01479608     History of Changes
Obsolete Identifiers: NCT01311453
Other Study ID Numbers: SECA-II
Study First Received: November 22, 2011
Last Updated: June 3, 2013
Health Authority: Norway: Regional Committees for Medical and Health Research Ethics (REK)

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases

ClinicalTrials.gov processed this record on July 23, 2014