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Recruiting

Liver Transplantation and Colorectal Cancer

NCT01479608 · Oslo University Hospital
In plain English

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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
About this study
Arm D: use of extended criteria donors (ECD)
Eligibility 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. Additional inclusion criteria for patients included in part Arm D: Patients with expected overall survival of 6-12 months without a liver transplant. The patient might be included without further chemotherapy treatment. Patients may have resectable pulmonary lesions at time of inclusion in the present study. 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.
Study design
Enrollment target: 25 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2012-04-11
Estimated completion: 2027-12
Last updated: 2024-02-07
Interventions
Procedure: Liver transplantation and liver resection
Primary outcomes
  • Overall survival (10 years)
Sponsor
Oslo University Hospital · other
Contacts & investigators
ContactMagnus Smedman, MD · contact · torha@ous-hf.no · 23026600
All locations (1)
Oslo University HospitalRecruiting
Oslo, Norway
Liver Transplantation and Colorectal Cancer · TrialPath