Metastatic Colorectal CancerNCT04513457
Chemotherapy for Resectable Colorectal Liver Metastases
An observational study of Metastatic Colorectal Cancer and Metastatic Liver Cancer, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 9 sites in 3 countries.
Trial summary
There is a degree of uncertainty regarding the role of perioperative chemotherapy (CTx) in the treatment of resectable colorectal liver metastases (CRLM). In the clinical practice, the combination of surgery and CTx is increasingly accepted as treatment for CRLM, especially in the context of patients with synchronous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Metastatic Liver Cancer
- What is being tested?
- Liver resection and Neoadjuvant chemotherapy, Liver resection and Adjuvant chemotherapy and Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 967 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 1 Jan 2010to 30 Sep 2020
- 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
- Adult, Older adult
Study population: All patients undergoing liver resection for colorectal metastases between January 1, 2010 and December 31, 2014, inclusive
Who may be able to join
- Patients older than 18 years with resectable liver metastases of histologically confirmed primary colorectal carcinoma.
- Minimum follow-up of five years.
Who cannot join
- Patients with extrahepatic disease
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Spain7 sites
Hospital Universitario de Badajoz
Badajoz
Hospital Dr. Josep Trueta
Girona
Hospital Universitario de Jaén
Jaén
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria
Hospital Clínico Universitario de Valencia
Valencia, Valencia
United Kingdom1 site
Liverpool University Hospitals NHS Foundation Trust
Liverpool
About this study
Official title: Perioperative Chemotherapy Versus Surgery for Resectable Colorectal Liver Metastases: a Multicenter Propensity Score Matched Analysis on Long-term Outcomes
There is a degree of uncertainty regarding the role of perioperative chemotherapy (CTx) in the treatment of resectable colorectal liver metastases (CRLM). In the clinical practice, the combination of surgery and CTx is increasingly accepted as treatment for CRLM, especially in the context of patients with synchronous disease or metachronous disease with a high risk of recurrence. However, controversy exists whether all patients with resectable CRLM benefit from perioperative CTx.
There is paucity of good quality studies on this topic. A pooled analysis of two phase III randomized clinical trial, closed prematurely because of slow accrual, showed a marginal statistical significance in favor of adjuvant CTx. Nevertheless, long term results of the EPOC trial founded benefit in disease free survival (DFS) with no difference in overall survival (OS) when perioperative CTx with FOLFOX4 was compared with surgery alone for resectable CRLM. Furthermore, a retrospective series from Ayez et al showed that patients with a high CRS benefit from neo-adjuvant CTx while in patients with a low risk profile did not. On the other side, another retrospective series from the MSKCC showed the timing of additional CTx for resectable CRLM was not associated with improved outcomes. The ongoing CHARISMA trial is currently comparing the outcomes of neo-adjuvant CTx followed by surgery versus surgery alone in high-risk patients with resectable CRLM.
This uncertainty regarding CRLM management may partly be due to the fact that these studies are not well powered to detect minor differences in long term outcomes and they often involved a very heterogenous group of patients with both synchronous and metachronous CRLM, not stratified by clinical risk score (CRS) as described by Fong et al.
- Being tested
- Liver resection and Neoadjuvant chemotherapy, Liver resection and Adjuvant chemotherapy, Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy, Liver resection
- Keywords
- Colorectal liver metastases, Liver resection, Hepatectomy
- Medical subject headings
- Colorectal Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resection and Neoadjuvant chemotherapyOther
Liver resection and Adjuvant chemotherapyOther
Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapyOther
Liver resectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Liver resection and Neoadjuvant chemotherapy | Liver resection and Neoadjuvant chemotherapy Receives: Other: Liver resection and Neoadjuvant chemotherapy | |
| Liver resection and Adjuvant chemotherapy | Liver resection and Adjuvant chemotherapy Receives: Other: Liver resection and Adjuvant chemotherapy | |
| Liver resection, Neoadjuvant and Adjuvant chemotherapy | Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy Receives: Other: Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy | |
| Liver resection | Liver resection Receives: Procedure: Liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival based on perioperative treatment
Overall survival based on perioperative treatment
Measured: 5 years of follow-up
Cancer survival based on perioperative treatment
Cancer survival based on perioperative treatment
Measured: 5 years of follow-up
Disease-free survival based on perioperative treatment
Disease-free survival based on perioperative treatment
Measured: 5 years of follow-up
Peri-operative morbidity
Peri-operative morbidity
Measured: 5 years of follow-up
Peri-operative mortality
Peri-operative mortality
Measured: 5 years of follow-up
Secondary outcomes (3)
Overall survival, cancer survival and disease-free survival related with biological markers
Overall survival, cancer survival and disease-free survival related with biological markers
Measured: 5 years of follow-up
Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.
Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.
Measured: 5 years of follow-up
Overall survival, cancer survival and disease-free survival based related with simultaneous thermal ablation performed at the same time of the surgical excision.
Overall survival, cancer survival and disease-free survival based related with simultaneous thermal ablation performed at the same time of the surgical excision.
Measured: 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Jan 2010
- Primary completion31 Jul 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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
- Retrospective
- Enrolment
- 967 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Collaborators
- Marcello Di Martino
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513457
- Sponsor's protocol ID
- Chemotherapy-liver-metastases
- Status last verified
- Mar 2021
- First submitted
- 11 Aug 2020
- Last updated
- 29 Mar 2021
- 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 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Chemotherapy Versus Surgery for Resectable Colorectal Liver Metastases: a Multicenter Propensity Score Matched Analysis on Long-term Outcomes
- ClinicalTrials.gov ID
- NCT04513457
- Acronym / sponsor ID
- Chemotherapy-liver-metastases
- Keywords
- Colorectal liver metastases, Liver resection, Hepatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 967 participants (actual)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Collaborators
- Marcello Di Martino
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 14 Aug 2020 (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.
There is a degree of uncertainty regarding the role of perioperative chemotherapy (CTx) in the treatment of resectable colorectal liver metastases (CRLM). In the clinical practice, the combination of surgery and CTx is increasingly accepted as treatment for CRLM, especially in the context of patients with synchronous disease or metachronous disease with a high risk of recurrence. However, controversy exists whether all patients with resectable CRLM benefit from perioperative CTx.
There is paucity of good quality studies on this topic. A pooled analysis of two phase III randomized clinical trial, closed prematurely because of slow accrual, showed a marginal statistical significance in favor of adjuvant CTx. Nevertheless, long term results of the EPOC trial founded benefit in disease free survival (DFS) with no difference in overall survival (OS) when perioperative CTx with FOLFOX4 was compared with surgery alone for resectable CRLM. Furthermore, a retrospective series from Ayez et al showed that patients with a high CRS benefit from neo-adjuvant CTx while in patients with a low risk profile did not. On the other side, another retrospective series from the MSKCC showed the timing of additional CTx for resectable CRLM was not associated with improved outcomes. The ongoing CHARISMA trial is currently comparing the outcomes of neo-adjuvant CTx followed by surgery versus surgery alone in high-risk patients with resectable CRLM.
This uncertainty regarding CRLM management may partly be due to the fact that these studies are not well powered to detect minor differences in long term outcomes and they often involved a very heterogenous group of patients with both synchronous and metachronous CRLM, not stratified by clinical risk score (CRS) as described by Fong et al.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Liver resection and Neoadjuvant chemotherapy | – | Other: Liver resection and Neoadjuvant chemotherapyLiver resection and Neoadjuvant chemotherapy |
| Liver resection and Adjuvant chemotherapy | – | Other: Liver resection and Adjuvant chemotherapyLiver resection and Adjuvant chemotherapy |
| Liver resection, Neoadjuvant and Adjuvant chemotherapy | – | Other: Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapyLiver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy |
| Liver resection | – | Procedure: Liver resectionLiver resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing liver resection for colorectal metastases between January 1, 2010 and December 31, 2014, inclusive
Key inclusion criteria (2 listed)
- Patients older than 18 years with resectable liver metastases of histologically confirmed primary colorectal carcinoma.
- Minimum follow-up of five years.
Key exclusion criteria (1 listed)
- Patients with extrahepatic disease
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 resection and Neoadjuvant chemotherapy | Other | Liver resection and Neoadjuvant chemotherapy |
| Liver resection and Adjuvant chemotherapy | Other | Liver resection and Adjuvant chemotherapy |
| Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy | Other | Liver resection, Neoadjuvant and Adjuvant chemotherapy |
| Liver resection | Procedure or surgery | Liver resection |
Primary outcome
Overall survival based on perioperative treatment
Time frame: 5 years of follow-up
Overall survival based on perioperative treatment
Cancer survival based on perioperative treatment
Time frame: 5 years of follow-up
Cancer survival based on perioperative treatment
Disease-free survival based on perioperative treatment
Time frame: 5 years of follow-up
Disease-free survival based on perioperative treatment
Peri-operative morbidity
Time frame: 5 years of follow-up
Peri-operative morbidity
Peri-operative mortality
Time frame: 5 years of follow-up
Peri-operative mortality
3 secondary outcomes
Overall survival, cancer survival and disease-free survival related with biological markers
Time frame: 5 years of follow-up
Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.
Time frame: 5 years of follow-up
Overall survival, cancer survival and disease-free survival based related with simultaneous thermal ablation performed at the same time of the surgical excision.
Time frame: 5 years of follow-up
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 29 Mar 2021.
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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.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer and Metastatic Liver Cancer, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 9 sites in 3 countries.
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 2 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 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, France, United Kingdom. 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?
Overall survival based on perioperative treatment (time frame: 5 years of follow-up). The study lists 5 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 29 Mar 2021.