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

  • STATUS
    Recruiting
  • End date
    Jan 28, 2027
  • participants needed
    30
  • sponsor
    Oslo University Hospital
Updated on 28 October 2022
cancer
blood test
metastasis
progressive disease
liver metastasis
TACE
adenocarcinoma
pet/ct scan
hepatectomy
selective internal radiation therapy

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.

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.

Details
Condition Liver Metastases, Colorectal Cancer
Treatment Chemotherapy, Liver transplantation
Clinical Study IdentifierNCT03494946
SponsorOslo University Hospital
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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
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