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Compares treatment options for Liver Metastases
Official title Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer
ClinicalTrials.gov ID: NCT03494946
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, being studied as a potential treatment for liver metastases.
Also referred to as Other treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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 assigned by chance before evaluation 8-12 weeks after starting 2. line chemotherapy.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oslo, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.