Colorectal Cancer MetastaticNCT05273489
Chemotherapy and Tumor Clearance in Hepatic Resections for Colorectal Liver Metastases.
An observational study of Colorectal Cancer Metastatic and Liver Metastases, run by Hospital Maciel.
Trial summary
Retrospective analysis of a prospectively collected database of 170 patients between 2004 and 2020, who underwent liver resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital trying to determine rates and patterns of recurrence following liver resections for CRLM and concurrently… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Liver Metastases
- What is being tested?
- Hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2004to 31 Oct 2021
- How long will I take part?
- 10 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Australian citizens (most of them locals) treated at The Queen Elizabeth Hospital, Adelaide, SA.
Who may be able to join
- Patients who underwent a liver resection for CRLM at The Queen Elizabeth Hospital between December 2004 to September 2020
Who cannot join
- Patients whose procedures were abandoned due to unresectable tumour burden
About this study
Official title: Effect of Chemotherapy and Tumor Clearance in Hepatic Resections for Colorectal Liver Metastases. A Single-centre Cohort Study
Retrospective analysis of a prospectively collected database of 170 patients between 2004 and 2020, who underwent liver resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital trying to determine rates and patterns of recurrence following liver resections for CRLM and concurrently, characterise clinical, pathological and treatment-related factors that could function as predictors of recurrence or survival, particularly neoadjuvant chemotherapy and tumour clearance.
Read the detailed description
This is a descriptive, observational study with retrospective analysis of a prospectively collated database. This database included all patients who underwent curative hepatic resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital (Adelaide, Australia) between December 2004 and October 2020.
- Conditions
- Colorectal Cancer Metastatic, Liver Metastases
- Being tested
- Hepatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepatectomyProcedure or surgery
Also called Chemotherapy
Neoadjuvant treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Recurrence rate
Measured: From surgery to recurrence, up to 16 years
Survival
up to16 years
Measured: From surgery to death or end of the study, up to 16 years
Secondary outcomes (2)
Resection margins
Resection margins of the liver resection
Measured: From surgery to death or end of the study, up to 16 years
Neoadjuvant Chemotherapy
Neoadjuvant Chemotherapy (yes or not)
Measured: From surgery to death or end of the study, up to 16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Jan 2004
- Primary completion31 Dec 2020
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 170 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Hospital Maciel
- Sponsor type
- University, hospital or other
- Collaborators
- University of Adelaide
- Responsible party
- Principal investigator, Mauro Andres Perdomo, MD, MHA, Hospital Maciel
- Investigators
- Mauro A Perdomo, MD, MHA, Principal investigator, Assitant Professor at Clinica Quirurgica 3. Universidad de la Republica. Monteviedo, Uruguay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273489
- Sponsor's protocol ID
- CRLM1
- Status last verified
- Mar 2022
- First submitted
- 24 Feb 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data could be provided on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chemotherapy and Tumor Clearance in Hepatic Resections for Colorectal Liver Metastases. A Single-centre Cohort Study
- ClinicalTrials.gov ID
- NCT05273489
- Acronym / sponsor ID
- CRLM1
- Conditions
- Colorectal Cancer Metastatic, Liver Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Hospital MacielUniversity, hospital or other
- Collaborators
- University of Adelaide
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 10 Mar 2022 (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.
Retrospective analysis of a prospectively collected database of 170 patients between 2004 and 2020, who underwent liver resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital trying to determine rates and patterns of recurrence following liver resections for CRLM and concurrently, characterise clinical, pathological and treatment-related factors that could function as predictors of recurrence or survival, particularly neoadjuvant chemotherapy and tumour clearance.
Detailed description
This is a descriptive, observational study with retrospective analysis of a prospectively collated database. This database included all patients who underwent curative hepatic resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital (Adelaide, Australia) between December 2004 and October 2020.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Australian citizens (most of them locals) treated at The Queen Elizabeth Hospital, Adelaide, SA.
Key inclusion criteria (1 listed)
- Patients who underwent a liver resection for CRLM at The Queen Elizabeth Hospital between December 2004 to September 2020
Key exclusion criteria (1 listed)
- Patients whose procedures were abandoned due to unresectable tumour burden
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 |
|---|---|---|
| HepatectomyAlso: ChemotherapyNeoadjuvant treatment | Procedure or surgery | – |
Primary outcome
Recurrence
Time frame: From surgery to recurrence, up to 16 years
Recurrence rate
Survival
Time frame: From surgery to death or end of the study, up to 16 years
up to16 years
2 secondary outcomes
Resection margins
Time frame: From surgery to death or end of the study, up to 16 years
Neoadjuvant Chemotherapy
Time frame: From surgery to death or end of the study, up to 16 years
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 10 Mar 2022.
- Individual participant dataSharing planned: No. Data could be provided on reasonable request
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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.
Mauro A Perdomo, MD, MHA principal investigator
Assitant Professor at Clinica Quirurgica 3. Universidad de la Republica. Monteviedo, Uruguay
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic and Liver Metastases, run by Hospital Maciel.
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 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Recurrence (time frame: From surgery to recurrence, up to 16 years). The study lists 2 primary outcomes in all. 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 10 Mar 2022.