Liver MetastasesSECAIIINCT03494946
Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer
A study testing Liver transplantation and Chemotherapy in people with Liver Metastases and Colorectal Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases, Colorectal Cancer
- What is being tested?
- Liver transplantation and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 5 Dec 2016to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo
Magnus Smedman, MD, 23026600 ext. +47, torha@ous-hf.no
Maria Gjerde, +4723070000, mgjerde@ous-hf.no
About this study
Official title: A Randomized Clinical Trial Comparing Overall Survival in Selected Patients With ColoRectal Carcinoma Treated by Liver Transplantation or Chemotherapy
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.
Read the detailed description
Patients with non-resectable CRC liver metastases evaluated at the liver MDT at Oslo University Hospital, Rikshospitalet will be included in the study. Patients should have progressive disease on 1.line chemotherapy or the treatment should have been stopped due to toxicity. Patients randomized to Ltx will if applicable stop bevazicumab. All patients (both arms) will start further treatment that may include chemotherapy, TACE, SIRT or other available treatment options. Patients not receiving a donor liver graft within 3 months after listing for transplantation will be taken off the waiting list and transferred to the chemotherapy/other treatment option group. Patients randomized to Ltx and developing progressive disease beyond the inclusion/exclusion criteria during the time on the waiting list will be excluded from the study and receive best treatment option at the discretion of the treating physician.
- Conditions
- Liver Metastases, Colorectal Cancer
- Being tested
- Liver transplantation, Chemotherapy
- Keywords
- Liver metastasis, Colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
ChemotherapyDrug
Also called Other treatment
May include chemotherapy, TACE, SIRT or other available treatment options.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Patients that suffer from Colorectal cancer and metastasis to liver that are randomized to Group A, will undergo Liver transplantation Receives: Procedure: Liver transplantation |
| Arm B | Active comparator | Patients that suffer from Colorectal cancer and metastasis to liver that are randomized to Group B, will be given chemotherapy, TACE, SIRT or other available treatment options. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
To determine overall survival after Ltx compared to palliative chemotherapy/other treatment in patients with progressive disease on chemotherapy or intolerance to 1-line chemotherapy.
Measured: 2 years from time of randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start5 Dec 2016
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized study were half of the subjects will be given standard chemo therapy and the other half will undergo liver transplantation.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Smedman, MD, Oslo University Hospital
- Investigators
- Magnus Smedman, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494946
- Sponsor's protocol ID
- 2016/1657 SECAIII
- Acronym
- SECAIII
- Status last verified
- Feb 2024
- First submitted
- 4 Apr 2018
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Overall Survival in Selected Patients With ColoRectal Carcinoma Treated by Liver Transplantation or Chemotherapy
- ClinicalTrials.gov ID
- NCT03494946
- Acronym / sponsor ID
- SECAIII / 2016/1657 SECAIII
- Conditions
- Liver Metastases, Colorectal Cancer
- Keywords
- Liver metastasis, Colorectal cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with non-resectable CRC liver metastases evaluated at the liver MDT at Oslo University Hospital, Rikshospitalet will be included in the study. Patients should have progressive disease on 1.line chemotherapy or the treatment should have been stopped due to toxicity. Patients randomized to Ltx will if applicable stop bevazicumab. All patients (both arms) will start further treatment that may include chemotherapy, TACE, SIRT or other available treatment options. Patients not receiving a donor liver graft within 3 months after listing for transplantation will be taken off the waiting list and transferred to the chemotherapy/other treatment option group. Patients randomized to Ltx and developing progressive disease beyond the inclusion/exclusion criteria during the time on the waiting list will be excluded from the study and receive best treatment option at the discretion of the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized study were half of the subjects will be given standard chemo therapy and the other half will undergo liver transplantation.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Procedure: Liver transplantationPatients that suffer from Colorectal cancer and metastasis to liver that are randomized to Group A, will undergo Liver transplantation |
| Arm B | Active comparator | Drug: ChemotherapyPatients that suffer from Colorectal cancer and metastasis to liver that are randomized to Group B, will be given chemotherapy, TACE, SIRT or other available treatment options. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver transplantation | Procedure or surgery | Arm A |
| ChemotherapyAlso: Other treatmentMay include chemotherapy, TACE, SIRT or other available treatment options. | Drug | Arm B |
Primary outcome
Overall Survival
Time frame: 2 years from time of randomisation
To determine overall survival after Ltx compared to palliative chemotherapy/other treatment in patients with progressive disease on chemotherapy or intolerance to 1-line chemotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magnus Smedman, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver transplantation and Chemotherapy in people with Liver Metastases and Colorectal Cancer, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magnus Smedman, MD (23026600, torha@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 2 years from time of randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.