Colorectal Liver MetastasesNCT00779272
Impact of Preoperative Chemotherapy on Complications and Regeneration After Resection of Colorectal Liver Metastases
An observational study of Colorectal Liver Metastases, run by University of Zurich at 1 site in Switzerland.
Trial summary
The objective of this study is to evaluate for the first time not only the impact of neoadjuvant chemotherapy on clinical outcome, but also on liver regeneration after liver resection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Liver Metastases
- How many people
- 184 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2008to Oct 2008
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Records from 184 consecutive patients undergoing liver resection due to colorectal metastases between 2003 and July 2008 were reviewed from a prospective database
Who may be able to join
- Liver resection due to colorectal liver metastases between 2003 and 2007
Who cannot join
- Incomplete assessment of preoperative chemotherapy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Departement of Visceral and Transplantation Surgery of the University of Zurich
Zurich, Canton of Zurich, 8091
About this study
The objective of this study is to evaluate for the first time not only the impact of neoadjuvant chemotherapy on clinical outcome, but also on liver regeneration after liver resection.
- Conditions
- Colorectal Liver Metastases
- Keywords
- neoadjuvant chemotherapy, clinically postoperative outcome, liver regeneration after liver resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Without preoperative chemotherapy | |
| 2 | With preoperative chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complications and liver regeneration
Measured: 2003- July 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Liver MetastasesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779272
- Sponsor's protocol ID
- StV 29-2008
- Status last verified
- Oct 2008
- First submitted
- 23 Oct 2008
- Last updated
- 24 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Chemotherapy on Complications and Regeneration After Resection of Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT00779272
- Acronym / sponsor ID
- StV 29-2008
- Conditions
- Colorectal Liver Metastases
- Keywords
- neoadjuvant chemotherapy, clinically postoperative outcome, liver regeneration after liver resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 24 Oct 2008 (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.
The objective of this study is to evaluate for the first time not only the impact of neoadjuvant chemotherapy on clinical outcome, but also on liver regeneration after liver resection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Without preoperative chemotherapy |
| 2 | – | –With preoperative chemotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Records from 184 consecutive patients undergoing liver resection due to colorectal metastases between 2003 and July 2008 were reviewed from a prospective database
Key inclusion criteria (1 listed)
- Liver resection due to colorectal liver metastases between 2003 and 2007
Key exclusion criteria (1 listed)
- Incomplete assessment of preoperative chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Complications and liver regeneration
Time frame: 2003- July 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Liver Metastases, run by University of Zurich at 1 site in Switzerland.
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 1 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: finished, as of the sponsor's last update on 24 Oct 2008. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative Complications and liver regeneration (time frame: 2003- July 2008). 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 24 Oct 2008.