NCT03494946 Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer
| NCT ID | NCT03494946 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Liver Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2016-12-05 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2016-12-05 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Magnus Smedman, MD
PRINCIPAL INVESTIGATOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT03494946 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03494946 currently recruiting?
Yes, NCT03494946 is actively recruiting participants. Contact the research team at torha@ous-hf.no for enrollment information.
Where is the NCT03494946 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT03494946 clinical trial?
NCT03494946 is sponsored by Oslo University Hospital. The principal investigator is Magnus Smedman, MD at Oslo University Hospital. The trial plans to enroll 30 participants.