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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Liver Metastasis

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Authority:

Norway: Regional Committees for Medical and Health Research Ethics (REK)

Study ID:

SECA-II

NCT ID:

NCT01479608

Start Date:

November 2011

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Liver Metastasis
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms

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