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

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ClinicalTrials.gov Identifier: NCT03494946
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Svein Dueland, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Liver Metastases Colorectal Cancer Procedure: Liver transplantation Drug: Chemotherapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized study were half of the subjects will be given standard chemo therapy and the other half will undergo liver transplantation.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Overall Survival in Selected Patients With ColoRectal Carcinoma Treated by Liver Transplantation or Chemotherapy
Actual Study Start Date : December 5, 2016
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine


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 Name: Other treatment




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years from time of randomisation ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494946


Contacts
Contact: Svein Dueland, PhD +4722934000 svedue@ous-hf.no
Contact: Maria Gjerde +4723070000 mgjerde@ous-hf.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Svein Dueland, PhD    +4722934000    svedue@ous-hf.no   
Contact: Maria Gjerde    +4723070000    mgjerde@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Svein Dueland, PhD Oslo University Hospital

Additional Information:
Responsible Party: Svein Dueland, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03494946     History of Changes
Other Study ID Numbers: 2016/1657 SECAIII
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Svein Dueland, Oslo University Hospital:
Liver metastasis
Colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
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 Extracts
Hematinics