SECAIII: Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer

Sponsor

Oslo University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03494946

Collaborator

(none)

Enrollment

Location

Arms

120.9

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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.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 :

Dec 5, 2016

Anticipated Primary Completion Date :

Jan 1, 2027

Anticipated Study Completion Date :

Jan 1, 2027

Arms and Interventions

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 Names: Other treatment

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 Names:

Other treatment

Outcome Measures

Primary Outcome Measures

Overall Survival [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway

Sponsors and Collaborators

Oslo University Hospital

Investigators

Principal Investigator: Svein Dueland, PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

European Liver Transplant registry

Publications

None provided.

Responsible Party:

Svein Dueland, PhD, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT03494946

Other Study ID Numbers:

2016/1657 SECAIII

First Posted:

Apr 11, 2018

Last Update Posted:

Sep 16, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Svein Dueland, PhD, Oslo University Hospital

Liver metastasis

Colorectal cancer

Additional relevant MeSH terms:

Colorectal Neoplasms

Neoplasm Metastasis

Study Results

No Results Posted as of Sep 16, 2020