Colo-rectal CancerPhase 2NCT00294827
Liver Transplantation and Metastatic Colo-rectal Cancer.
A Phase 2 study testing Liver transplantation and colo-rectal cancer in people with Colo-rectal Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Survival of colo-rectal cancer patients after liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Liver transplantation and colo-rectal cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2006to Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Survival of colo-rectal cancer patients after liver transplantation.
Read the detailed description
Survival, time to progression, other malignancy, side-effects, quality of life.
- Conditions
- Colo-rectal Cancer
- Being tested
- Liver transplantation and colo-rectal cancer
- Keywords
- Liver transplantation
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantation and colo-rectal cancerProcedure or surgery
Liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| Liver transplantation | Experimental | Not described Receives: Procedure: Liver transplantation and colo-rectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 6 years
Secondary outcomes (1)
Time to progression side-effects
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- Svein Dueland, MD, PhD, Principal investigator, Rikshospitalet-Radiumhospitalet RRHF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294827
- Sponsor's protocol ID
- S-05409 (SECA I)
- Status last verified
- Nov 2023
- First submitted
- 21 Feb 2006
- Last updated
- 7 Nov 2023
- Results posted
- No
Publications
Foss A, Adam R, Dueland S. Liver transplantation for colorectal liver metastases: revisiting the concept. Transpl Int. 2010 Jul;23(7):679-85. doi: 10.1111/j.1432-2277.2010.01097.x. Epub 2010 Apr 30.
PubMed 20477993
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation and Metastatic Colo-rectal Cancer.
- ClinicalTrials.gov ID
- NCT00294827
- Acronym / sponsor ID
- S-05409 (SECA I)
- Conditions
- Colo-rectal Cancer
- Keywords
- Liver transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 22 Feb 2006 (estimated)
- 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.
Survival of colo-rectal cancer patients after liver transplantation.
Detailed description
Survival, time to progression, other malignancy, side-effects, quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplantation | Experimental | Procedure: Liver transplantation and colo-rectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 and colo-rectal cancerLiver transplantation | Procedure or surgery | Liver transplantation |
Primary outcome
Survival
Time frame: 6 years
1 secondary outcome
Time to progression side-effects
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 20477993Foss A, Adam R, Dueland S. Liver transplantation for colorectal liver metastases: revisiting the concept. Transpl Int. 2010 Jul;23(7):679-85. doi: 10.1111/j.1432-2277.2010.01097.x. Epub 2010 Apr 30.
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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. This study is not recruiting at the moment.
Svein Dueland, MD, PhD principal investigator
Rikshospitalet-Radiumhospitalet RRHF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liver transplantation and colo-rectal cancer in people with Colo-rectal 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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00294827, which also lists 1 linked publication.
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 7 Nov 2023.