Colonic CancerRENACINCT04683783
National Registry of Liver First Approach
An observational study of Colonic Cancer and Rectal Cancer, run by Hospital Miguel Servet at 1 site in Spain.
Trial summary
Liver metastases are present in 15-25% of patients with colorectal cancer at the time of diagnosis of the primary tumor, which is defined as synchronous liver metastases. Treatment for the potential cure of this disease includes surgical resection of both the primary tumor and liver metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Cancer, Rectal Cancer, Liver Metastases
- How many people
- 168 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2019to 30 Nov 2020
- How long will I take part?
- 3 Months
- 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: All patients operated on in the participating Spanish centers with colorectal cancer and synchronous liver metastases who underwent a liver first approach during the study period and that meet the inclusion criteria
Who may be able to join
- Patients ≥ 18 year old.
- Scheduled surgery for colorectal cancer with synchronous liver metastases using the liver first approach.
- ASA score I-III.
- They have signed the informed consent.
Who cannot join
- Patients under 18 year old.
- ASA ≥ IV.
- Urgent surgery.
- Patients who have not signed the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RENACI Project: National Registry of Liver First Approach
Liver metastases are present in 15-25% of patients with colorectal cancer at the time of diagnosis of the primary tumor, which is defined as synchronous liver metastases. Treatment for the potential cure of this disease includes surgical resection of both the primary tumor and liver metastases. The liver first approach was described by Mentha for patients with asymptomatic rectal tumors with with initially unresectable or borderline resectable liver metastases. There is little data in the scientific literature on how many patients scheduled for this strategy complete both surgeries and/or undergo the full chemo/radiation therapy.
Read the detailed description
Liver metastases are present in 15-25% of patients with colorectal cancer at the time of diagnosis of the primary tumor, which is defined as synchronous liver metastases. Treatment for the potential cure of this disease includes surgical resection of both the primary tumor and liver metastases. However, due to the comorbidity or extent of the tumor disease, only a minority of patients are candidates for curative resections. When surgical treatment is indicated, different strategies can be used. In the classic strategy, the primary tumor is resected first, followed by surgery for metastases and, after that, adjuvant chemotherapy. More recently, simultaneous resection of primary and liver lesions has been used, mainly for limited liver disease without the need for large-volume liver resections. A third option is preoperative chemotherapy, followed by resection of liver metastases and surgery of the primary tumor in a second stage. This technique was initially described in 2006 by Mentha for patients with asymptomatic rectal tumors with initially unresectable or borderline resectable liver metastases. These patients were treated with neoadjuvant chemotherapy, followed by surgery for liver metastases, chemo/radiotherapy of the primary tumor, and second stage surgery. This is what is called surgery or reverse strategy (liver first approach in the Anglo-Saxon world). This strategy has the potential advantage of allowing resection of advanced liver disease in patients when the primary tumor is asymptomatic. Advanced liver disease is the leading cause of mortality in these patients. Subsequently, this strategy has been used in colorectal tumors of any location with synchronous metastases. No clear advantage or disadvantage has been demonstrated with any of the three strategies in terms of long-term survival. There is also no prospective randomized clinical trial comparing classical with reverse strategy.
Most of the previous studies that evaluated this strategy only included patients with liver resection, not the primary one. Therefore, there is little data in the scientific literature on how many patients scheduled for this strategy complete both surgeries and/or undergo the full chemo/radiation therapy. The potential advantage of this strategy is the possibility of rescuing more patients with colorectal cancer liver metastases, thus increasing survival.
- Conditions
- Colonic Cancer, Rectal Cancer, Liver Metastases
- Keywords
- Liver first approach, Reverse strategy
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who complete the entire cycle
Percentage of patients who complete the cycle: neoadjuvant chemotherapy - liver surgery - CT / RT of the primary - surgery of the primary tumor
Measured: 90 days
Secondary outcomes (2)
Mortality rate
Postoperative mortality including liver surgery and primary tumor
Measured: 90 days
Morbidity rate
Postoperative morbidity including liver surgery and primary tumor (all type of postoperative complications)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Jun 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Colonic 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
- Prospective
- Enrolment
- 168 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hospital Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Association of Surgeons (AEC)
- Responsible party
- Principal investigator, Mario Serradilla, MD, FACS, Hospital Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683783
- Sponsor's protocol ID
- PI19/256
- Acronym
- RENACI
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jegatheeswaran S, Mason JM, Hancock HC, Siriwardena AK. The liver-first approach to the management of colorectal cancer with synchronous hepatic metastases: a systematic review. JAMA Surg. 2013 Apr;148(4):385-91. doi: 10.1001/jamasurg.2013.1216.
PubMed 23715907de Jong MC, van Dam RM, Maas M, Bemelmans MH, Olde Damink SW, Beets GL, Dejong CH. The liver-first approach for synchronous colorectal liver metastasis: a 5-year single-centre experience. HPB (Oxford). 2011 Oct;13(10):745-52. doi: 10.1111/j.1477-2574.2011.00372.x. Epub 2011 Sep 5.
PubMed 21929676Lam VW, Laurence JM, Pang T, Johnston E, Hollands MJ, Pleass HC, Richardson AJ. A systematic review of a liver-first approach in patients with colorectal cancer and synchronous colorectal liver metastases. HPB (Oxford). 2014 Feb;16(2):101-8. doi: 10.1111/hpb.12083. Epub 2013 Mar 19.
PubMed 23509899Tsoulfas G, Pramateftakis MG. Management of rectal cancer and liver metastatic disease: which comes first? Int J Surg Oncol. 2012;2012:196908. doi: 10.1155/2012/196908. Epub 2012 Jun 20.
PubMed 22778934Mentha G, Majno PE, Andres A, Rubbia-Brandt L, Morel P, Roth AD. Neoadjuvant chemotherapy and resection of advanced synchronous liver metastases before treatment of the colorectal primary. Br J Surg. 2006 Jul;93(7):872-8. doi: 10.1002/bjs.5346.
PubMed 16671066Mayo SC, Pulitano C, Marques H, Lamelas J, Wolfgang CL, de Saussure W, Choti MA, Gindrat I, Aldrighetti L, Barrosso E, Mentha G, Pawlik TM. Surgical management of patients with synchronous colorectal liver metastasis: a multicenter international analysis. J Am Coll Surg. 2013 Apr;216(4):707-16; discussion 716-8. doi: 10.1016/j.jamcollsurg.2012.12.029. Epub 2013 Feb 21.
PubMed 23433970Adam R, De Gramont A, Figueras J, Guthrie A, Kokudo N, Kunstlinger F, Loyer E, Poston G, Rougier P, Rubbia-Brandt L, Sobrero A, Tabernero J, Teh C, Van Cutsem E; Jean-Nicolas Vauthey of the EGOSLIM (Expert Group on OncoSurgery management of LIver Metastases) group. The oncosurgery approach to managing liver metastases from colorectal cancer: a multidisciplinary international consensus. Oncologist. 2012;17(10):1225-39. doi: 10.1634/theoncologist.2012-0121. Epub 2012 Sep 7.
PubMed 22962059Adam R, de Gramont A, Figueras J, Kokudo N, Kunstlinger F, Loyer E, Poston G, Rougier P, Rubbia-Brandt L, Sobrero A, Teh C, Tejpar S, Van Cutsem E, Vauthey JN, Pahlman L; of the EGOSLIM (Expert Group on OncoSurgery management of LIver Metastases) group. Managing synchronous liver metastases from colorectal cancer: a multidisciplinary international consensus. Cancer Treat Rev. 2015 Nov;41(9):729-41. doi: 10.1016/j.ctrv.2015.06.006. Epub 2015 Jun 30.
PubMed 26417845Ihnat P, Vavra P, Zonca P. Treatment strategies for colorectal carcinoma with synchronous liver metastases: Which way to go? World J Gastroenterol. 2015 Jun 14;21(22):7014-21. doi: 10.3748/wjg.v21.i22.7014.
PubMed 26078580Waisberg J, Ivankovics IG. Liver-first approach of colorectal cancer with synchronous hepatic metastases: A reverse strategy. World J Hepatol. 2015 Jun 18;7(11):1444-9. doi: 10.4254/wjh.v7.i11.1444.
PubMed 26085905Sturesson C, Valdimarsson VT, Blomstrand E, Eriksson S, Nilsson JH, Syk I, Lindell G. Liver-first strategy for synchronous colorectal liver metastases - an intention-to-treat analysis. HPB (Oxford). 2017 Jan;19(1):52-58. doi: 10.1016/j.hpb.2016.10.005. Epub 2016 Nov 9.
PubMed 27838252Regimbeau JM, Cosse C, Kaiser G, Hubert C, Laurent C, Lapointe R, Isoniemi H, Adam R. Feasibility, safety and efficacy of two-stage hepatectomy for bilobar liver metastases of colorectal cancer: a LiverMetSurvey analysis. HPB (Oxford). 2017 May;19(5):396-405. doi: 10.1016/j.hpb.2017.01.008. Epub 2017 Mar 23.
PubMed 28343889
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RENACI Project: National Registry of Liver First Approach
- ClinicalTrials.gov ID
- NCT04683783
- Acronym / sponsor ID
- RENACI / PI19/256
- Conditions
- Colonic Cancer, Rectal Cancer, Liver Metastases
- Keywords
- Liver first approach, Reverse strategy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Hospital Miguel ServetUniversity, hospital or other
- Collaborators
- Spanish Association of Surgeons (AEC)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 24 Dec 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.
Liver metastases are present in 15-25% of patients with colorectal cancer at the time of diagnosis of the primary tumor, which is defined as synchronous liver metastases. Treatment for the potential cure of this disease includes surgical resection of both the primary tumor and liver metastases. The liver first approach was described by Mentha for patients with asymptomatic rectal tumors with with initially unresectable or borderline resectable liver metastases. There is little data in the scientific literature on how many patients scheduled for this strategy complete both surgeries and/or undergo the full chemo/radiation therapy.
Detailed description
Liver metastases are present in 15-25% of patients with colorectal cancer at the time of diagnosis of the primary tumor, which is defined as synchronous liver metastases. Treatment for the potential cure of this disease includes surgical resection of both the primary tumor and liver metastases. However, due to the comorbidity or extent of the tumor disease, only a minority of patients are candidates for curative resections. When surgical treatment is indicated, different strategies can be used. In the classic strategy, the primary tumor is resected first, followed by surgery for metastases and, after that, adjuvant chemotherapy. More recently, simultaneous resection of primary and liver lesions has been used, mainly for limited liver disease without the need for large-volume liver resections. A third option is preoperative chemotherapy, followed by resection of liver metastases and surgery of the primary tumor in a second stage. This technique was initially described in 2006 by Mentha for patients with asymptomatic rectal tumors with initially unresectable or borderline resectable liver metastases. These patients were treated with neoadjuvant chemotherapy, followed by surgery for liver metastases, chemo/radiotherapy of the primary tumor, and second stage surgery. This is what is called surgery or reverse strategy (liver first approach in the Anglo-Saxon world). This strategy has the potential advantage of allowing resection of advanced liver disease in patients when the primary tumor is asymptomatic. Advanced liver disease is the leading cause of mortality in these patients. Subsequently, this strategy has been used in colorectal tumors of any location with synchronous metastases. No clear advantage or disadvantage has been demonstrated with any of the three strategies in terms of long-term survival. There is also no prospective randomized clinical trial comparing classical with reverse strategy.
Most of the previous studies that evaluated this strategy only included patients with liver resection, not the primary one. Therefore, there is little data in the scientific literature on how many patients scheduled for this strategy complete both surgeries and/or undergo the full chemo/radiation therapy. The potential advantage of this strategy is the possibility of rescuing more patients with colorectal cancer liver metastases, thus increasing survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients operated on in the participating Spanish centers with colorectal cancer and synchronous liver metastases who underwent a liver first approach during the study period and that meet the inclusion criteria
Key inclusion criteria (4 listed)
- Patients ≥ 18 year old.
- Scheduled surgery for colorectal cancer with synchronous liver metastases using the liver first approach.
- ASA score I-III.
- They have signed the informed consent.
Key exclusion criteria (4 listed)
- Patients under 18 year old.
- ASA ≥ IV.
- Urgent surgery.
- Patients who have not signed the informed consent.
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
Percentage of patients who complete the entire cycle
Time frame: 90 days
Percentage of patients who complete the cycle: neoadjuvant chemotherapy - liver surgery - CT / RT of the primary - surgery of the primary tumor
2 secondary outcomes
Mortality rate
Time frame: 90 days
Morbidity rate
Time frame: 90 days
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 Dec 2020.
- Results publication: PubMed 23715907Jegatheeswaran S, Mason JM, Hancock HC, Siriwardena AK. The liver-first approach to the management of colorectal cancer with synchronous hepatic metastases: a systematic review. JAMA Surg. 2013 Apr;148(4):385-91. doi: 10.1001/jamasurg.2013.1216.
- Results publication: PubMed 21929676de Jong MC, van Dam RM, Maas M, Bemelmans MH, Olde Damink SW, Beets GL, Dejong CH. The liver-first approach for synchronous colorectal liver metastasis: a 5-year single-centre experience. HPB (Oxford). 2011 Oct;13(10):745-52. doi: 10.1111/j.1477-2574.2011.00372.x. Epub 2011 Sep 5.
- Results publication: PubMed 23509899Lam VW, Laurence JM, Pang T, Johnston E, Hollands MJ, Pleass HC, Richardson AJ. A systematic review of a liver-first approach in patients with colorectal cancer and synchronous colorectal liver metastases. HPB (Oxford). 2014 Feb;16(2):101-8. doi: 10.1111/hpb.12083. Epub 2013 Mar 19.
- Results publication: PubMed 22778934Tsoulfas G, Pramateftakis MG. Management of rectal cancer and liver metastatic disease: which comes first? Int J Surg Oncol. 2012;2012:196908. doi: 10.1155/2012/196908. Epub 2012 Jun 20.
- Results publication: PubMed 16671066Mentha G, Majno PE, Andres A, Rubbia-Brandt L, Morel P, Roth AD. Neoadjuvant chemotherapy and resection of advanced synchronous liver metastases before treatment of the colorectal primary. Br J Surg. 2006 Jul;93(7):872-8. doi: 10.1002/bjs.5346.
- Results publication: PubMed 23433970Mayo SC, Pulitano C, Marques H, Lamelas J, Wolfgang CL, de Saussure W, Choti MA, Gindrat I, Aldrighetti L, Barrosso E, Mentha G, Pawlik TM. Surgical management of patients with synchronous colorectal liver metastasis: a multicenter international analysis. J Am Coll Surg. 2013 Apr;216(4):707-16; discussion 716-8. doi: 10.1016/j.jamcollsurg.2012.12.029. Epub 2013 Feb 21.
- Results publication: PubMed 22962059Adam R, De Gramont A, Figueras J, Guthrie A, Kokudo N, Kunstlinger F, Loyer E, Poston G, Rougier P, Rubbia-Brandt L, Sobrero A, Tabernero J, Teh C, Van Cutsem E; Jean-Nicolas Vauthey of the EGOSLIM (Expert Group on OncoSurgery management of LIver Metastases) group. The oncosurgery approach to managing liver metastases from colorectal cancer: a multidisciplinary international consensus. Oncologist. 2012;17(10):1225-39. doi: 10.1634/theoncologist.2012-0121. Epub 2012 Sep 7.
- Results publication: PubMed 26417845Adam R, de Gramont A, Figueras J, Kokudo N, Kunstlinger F, Loyer E, Poston G, Rougier P, Rubbia-Brandt L, Sobrero A, Teh C, Tejpar S, Van Cutsem E, Vauthey JN, Pahlman L; of the EGOSLIM (Expert Group on OncoSurgery management of LIver Metastases) group. Managing synchronous liver metastases from colorectal cancer: a multidisciplinary international consensus. Cancer Treat Rev. 2015 Nov;41(9):729-41. doi: 10.1016/j.ctrv.2015.06.006. Epub 2015 Jun 30.
- Results publication: PubMed 26078580Ihnat P, Vavra P, Zonca P. Treatment strategies for colorectal carcinoma with synchronous liver metastases: Which way to go? World J Gastroenterol. 2015 Jun 14;21(22):7014-21. doi: 10.3748/wjg.v21.i22.7014.
- Results publication: PubMed 26085905Waisberg J, Ivankovics IG. Liver-first approach of colorectal cancer with synchronous hepatic metastases: A reverse strategy. World J Hepatol. 2015 Jun 18;7(11):1444-9. doi: 10.4254/wjh.v7.i11.1444.
- Results publication: PubMed 27838252Sturesson C, Valdimarsson VT, Blomstrand E, Eriksson S, Nilsson JH, Syk I, Lindell G. Liver-first strategy for synchronous colorectal liver metastases - an intention-to-treat analysis. HPB (Oxford). 2017 Jan;19(1):52-58. doi: 10.1016/j.hpb.2016.10.005. Epub 2016 Nov 9.
- Results publication: PubMed 28343889Regimbeau JM, Cosse C, Kaiser G, Hubert C, Laurent C, Lapointe R, Isoniemi H, Adam R. Feasibility, safety and efficacy of two-stage hepatectomy for bilobar liver metastases of colorectal cancer: a LiverMetSurvey analysis. HPB (Oxford). 2017 May;19(5):396-405. doi: 10.1016/j.hpb.2017.01.008. Epub 2017 Mar 23.
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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 Colonic Cancer and Rectal Cancer, run by Hospital Miguel Servet at 1 site in Spain.
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 4 inclusion and 4 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 Dec 2020. 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 Spain. 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?
Percentage of patients who complete the entire cycle (time frame: 90 days). 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 NCT04683783, which also lists 12 linked publications.
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 Dec 2020.