NCT04161092Active, not recruiting
The Swedish Study of Liver Transplantation for Non-resectable Colorectal Cancer Metastases
A Randomized Controlled, Open-label, Multicentre Study Evaluating if Liver Transplantation With Liver Grafts From Extended Criteria Donors Not Utilised for Approved Indications Increases Overall Survival in Patients With Non-resectable Isolated Liver Metastases From Colorectal Metastases, in Comparison With Best Alternative Care
Source: ClinicalTrials.gov · Last updated 28 Oct 2024
Brief summary (registry, in English)
To evaluate if the addition of liver transplantation primarily utilizing liver grafts from extended criteria donors not utilized for approved indications to conventional treatment of non-resectable/ non-abatable colorectal liver metastases (CLM) increases overall survival compared to best alternative care.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 31 Oct 2019
- Start date
- 1 Dec 2020
- Primary completion date
- Dec 2029
- Lead sponsor
- Vastra Gotaland Region
- Diseases
- Colorectal cancer
- NCT number
- NCT04161092
What you commit to
- Study type: Interventional
- Planned participants: 45
- From 1 Dec 2020 to the primary completion date, Dec 2029
- 2 sites 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
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study.
- Previous organ transplantation
Other illness
- Evidence of extrahepatic disease by PET-CT or CT-thorax/abdomen.
- Other malignancies within the last 5 years, except CRC and low risk tumours such as basaliomas.
- \* Liver metastases larger than 10 cm.
Other
- Weight loss \>10% the last 6 months
- Pathological lymphatic nodes in the abdomen. If a patient has pathological lymphatic nodules in the hepatoduodenal ligament, a staging operation with histo-pathological examination from the nodules with no signs of tumour cell involvement has to be performed before inclusion.
- BRAF (a gene that encodes a protein called b-raf) mutation in primary tumour
- microsatellite instability (MSI-H) in primary tumour
Who the study is looking for
- Patients with non-resectable, non-ablatable liver metastases from colorectal adenocarcinoma.
- Male or female 18 years or above.
- Primary tumour removed with an R0 resection, and histologically verified adenocarcinoma from colon or rectum
- Liver metastases measurable by MRI or CT according to RECIST version 1.1 Imaging within 4 weeks prior to inclusion.
- No signs of extrahepatic metastatic disease or local recurrence according to MRI and CT of thorax/abdomen and whole body Positron-emission tomography (PET)/ computed tomography (CT) scan.
- A colonoscopy performed within the last 12 months in order to exclude multifocal colorectal cancer (CRC) tumours.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Satisfactory blood tests: Hb ≥ 90 g/L (transfusions are permitted to achieve baseline hemoglobin level), White blood cell Count (WBC) \>3,0x109/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelet Count (PLT) \>75, Bilirubin\<2 x upper normal level, Aspartate aminotransferase (ASAT), Alanine aminotransferase (ALAT)\<5 x upper normal level, Calculated Creatinine clearance ≥ 50 mL/min(MDRD).
- Received at least 2 months of chemotherapy with no signs of progressive disease according to RECIST-criteria at the last evaluation before randomization.
- One year or more from the initial CRC diagnosis to the date of inclusion in the study
- Patient accepted for transplantation by a national study board
- Signed and dated written informed consent before the start of specific protocol procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Transplant Institute, Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Transplantation Unit, Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.