NCT03494946Recruiting
Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer
A Randomized Clinical Trial Comparing Overall Survival in Selected Patients With ColoRectal Carcinoma Treated by Liver Transplantation or Chemotherapy
Source: ClinicalTrials.gov · Last updated 6 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 4 Apr 2018
- Start date
- 5 Dec 2016
- Primary completion date
- Jan 2027
- Lead sponsor
- Oslo University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT03494946
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 5 Dec 2016 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Weight loss \>10% the last 6 months
- Patient BMI \> 30
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.