Colon CancerCoME-InNCT04871399
Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer
A study testing Conventional Right hemicolectomy (Non-CME) and Right hemicolectomy with CME+CVL in people with Colon Cancer, run by University of Turin, Italy at 14 sites in Italy.
Trial summary
An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Conventional Right hemicolectomy (Non-CME) and Right hemicolectomy with CME+CVL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 14 sitesItaly
- Study dates
- 13 Jul 2020to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists(ASA) grade I-III.
- Right colon cancer (*The right-sided location of the cancer is defined as the location from the caecum up to the proximal third of the transverse colon), preoperative assessment of tumor stage T2-T4a, any N or T any N+ according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015); no distant metastasis.
- Informed consent
Who cannot join
- Age > 85 years old.
- T1, N0
- T4b, any N
- BMI > 30.
- Metastatic disease (Abdominal and chest CT scan will be mandatory to exclude distant metastasis.)
- American Society of Anesthesiologists(ASA) grade IV.
Show all 12Show fewer
- History of cancer in recent 5 years.
- Need for Emergency surgery.
- Infectious disease requiring treatment.
- Pregnancy.
- Use of systemic steroids.
- No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Italy14 sites, 14 recruiting
- Not yet recruiting
Maggiore Bellaria Hospital, Bologna
Bologna, 40124
Elio Jovine, MD, elio.jovine@ausl.bologna.it
Raffaele Lombardi, MD, elio.jovine@ausl.bologna.it
- Not yet recruiting
Candiolo Cancer Institute - IRCCS
Candiolo, Torino, 10060
Giuseppe Spingolo, MD, gspinoglio@icloud.com
Dario Ribero, MD, dario.ribero@ircc.it
- Not yet recruiting
Università degli Studi di Ferrara
Ferrara, 44121
Gabriele Anania., MD, g.anania@unife.it
- Not yet recruiting
Ospedale Policlinico San Martino
Genova, 16132
Stefano Scabini, MD, stefanoscabini@libero.it
- Not yet recruiting
Ospedale della Misericordia
Grosseto, Arezzo, 52100
Paolo Pietro Bianchi, MD, bianchippt@gmail.com
- Not yet recruiting
S. Andrea Hospital
La Spezia, Spezia, 19121
Stefano Berti, MD, stefano.berti@asl5.liguria.it
Andrea Gennai, MD, andrea.gennai@asl5.liguria.it
- Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Messina, 98124
Giuseppe Navarra, MD, gnavarra@unime.it
- Not yet recruiting
European Institute of Oncology
Milan, 20141
Romario Uberto Fumagalli, MD, uberto.fumagalliromario@ieo.it
Laura Adamoli, MD, laura.adamoli@ieo.it
- Not yet recruiting
Federico II University
Naples, 80138
Francesco Corcione, MD, francesco.corcione@unina.it
Umberto Bracale, MD, umbertobracale@gmail.com
- Not yet recruiting
Ospedale E. Agnelli Pinerolo
Pinerolo, Torino, 10064
Andrea Muratore, MD, amuratore@aslto3.piemonte.it
- Not yet recruiting
University of Rome Tor Vergata
Rome, 00133
Giuseppe Sica, MD, sigisica@gmail.com
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
Domenico D'Ugo, MD, biondi.alberto@gmail.com
Alberto Biondi, MD, biondi.alberto@gmail.com
- Not yet recruiting
Ospedale Città di Sesto San Giovanni
Sesto San Giovanni, Milano, 20099
Gianandrea Baldazzi., MD, gbaldazzi@hotmail.com
Diletta CassiniI., MD, diletta_cassini@yahoo.it
- Recruiting
University of Turin (AOU.San Luigi Gonzaga)
Torino, 10043
Mario Solej, MD, 00393388624939, mario.solej@unito.it
Aridai Resendiz, MD, 3512338942, aridai.resendiz@icloud.com
About this study
Official title: Complete Mesocolic Excision With Central Vascular Ligation in Comparison With Conventional Surgery for the Right Colon Cancer: An Italian Randomized Trial
An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy.
Read the detailed description
This study aims to compare the Complete Mesocolic Excision With Central Vascular Ligation (CME+CVL) with the standard (non-CME) right hemicolectomy in patients with right or proximal transverse colon cancer stage II-IV(AJCC 8th edition) to determine the short and long term outcomes in terms of disease-free survival (DFS) as a primary endpoint, and safety, oncologic outcomes, quality of surgery and quality of life (QoL) as secondary endpoints.
Eligible patients will be randomized with a 1:1 ratio between CME + CVL vs standard non-CME right colectomy. The randomization sequence will be generated centrally by a computed algorithm and kept concealed to investigators.
The Right colectomy with CME + CVL includes the removal of the accessory lymphovascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia. Despite the surgical approach and the type of procedure adopted, the operation should be strictly conducted following the general rules for colorectal oncologic resection, particularly as concerns proximal and distal margins length and lymph node retrieval.
All surgical approaches (open, laparoscopic, or robotic) will be allowed while the type of anastomosis performed and drain placement will be up to the surgeon's discretion.
Demographic, baseline, perioperative and postoperative characteristics will be analyzed as well.
The study expected to last six and a half years, of which one and a half years for recruiting 416 patients, 208 each arm, with five years of follow-up. Patients will be followed up at 1, 4, 12, 24, 36, and 60 months postoperatively.
- Conditions
- Colon Cancer
- Being tested
- Conventional Right hemicolectomy (Non-CME), Right hemicolectomy with CME+CVL
- Keywords
- colon cancer, Right colon cancer, Complete mesocolic excision, CME, Right Hemicolectomy, Right Colectomy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Right hemicolectomy (Non-CME)Procedure or surgery
Transecting the Ileocolic Vein and Artery close to the Superior Mesenteric Vessels without clearing the superior mesenteric vein (SMV) from the adipose tissue. Transecting the Right Colic Vein and Artery and superior right colic vein (when present) peripherally. Transecting the Right branches of the Middle Colic Vein (MCV) and the Middle Colic Artery (MCA) peripherally, without clearing the main trunk of the MCV and the MCA. The Right Gastroepiploic Vein and artery are never transacted.
Right hemicolectomy with CME+CVLProcedure or surgery
Separation of the visceral fascia from the parietal fascia by sharp dissection leaving intact mesocolon coverage. Transecting the supplying vessels at their origin from the main vessels, particularly:
- The Ileocolic Vessels, The Right Colic Vessels,The superior right colic vein (when present), The Right branches of the Middle Colic Vein and of the Middle Colic Artery
- The MCV and MCA at their origin in case of cancer of the hepatic flexure or of the proximal third of the transverse colon, as well as The Right Gastroepiploic Vessels at their origin from the gastrocolic trunk of Henle (GCTH) and the gastroduodenal artery.
The SMV should be cleared from all adipose tissue all along its anterior surface until its intrapancreatic entrance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Right hemicolectomy (Non-CME) | Active comparator | Patients will undergo conventional non-CME procedure. Receives: Procedure: Conventional Right hemicolectomy (Non-CME) |
| Right hemicolectomy with CME+CVL | Experimental | Patients will undergo Right hemicolectomy CME+CVL procedure. Receives: Procedure: Right hemicolectomy with CME+CVL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival at 3 years
The length of time after surgery without any signs or symptoms of local or distant recurrence.
Measured: 3 Years.
Secondary outcomes (12)
Safety-Operative time.
Total time from incision to skin closure expressed in minutes.
Measured: Intraoperative
Safety-Intraoperative blood loss.
Defined by the volume drained in cm2 into aspiration systems and weight of gauzes, calculated, subtracting the weight of the dry gauzes and volume of saline solution used for irrigation.
Measured: Intraoperative
Safety-Intraoperative blood transfusion.
Defined as the number of red blood cells, platelets, or plasma units transfused during the intraoperative time.
Measured: Intraoperative
Safety- Intraoperative Complications.
Defined as any deviation from the ideal intraoperative course occurring during the operative time, Using the Classification of Intraoperative Complications(CLASSIC).
Measured: Intraoperative
Early postoperative complications.
Number of patients with any deviation from the normal postoperative course grading by The Clavien-Dindo classification.
Measured: 30 postoperative days.
Late postoperative complications.
The number of patients with any deviation from the normal postoperative course grading by The Clavien-Dindo classification.
Measured: From the 31st postoperative days to the end of the study.
Safety- Length of stay.
Defined as the length of an inpatient episode of care, calculated from the day of operation to the first discharge and based on the number of nights spent in the hospital.
Measured: 30 Days.
Safety- Postoperative mortality rate.
The all-cause death rate, within 30 days after surgery in or out of the hospital.
Measured: 30 Days.
Overall Survival at 3 years
Defined as the time from random assignment to the date of death due to any cause.
Measured: 3 Years.
Overall Survival at 5 years.
Defined as the time from random assignment to the date of death due to any cause.
Measured: 5 Years.
Disease-free survival.
Defined as the length of time after Surgical treatment (CME+CVL or Conventional non-CME procedure) that the patient survives without any signs or symptoms of colon cancer.
Measured: 5 Years.
Other Oncologic outcomes.
The number of positive, negative, and total lymph nodes harvested, Quality of surgery specimen, quality of life by EORTC specific Questionnaires
Measured: 30 Days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start13 Jul 2020
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Colon 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University, Agnelli Hospital, Italy, Ospedale della Misericordia, Candiolo Cancer Institute - IRCCS, Maggiore Bellaria Hospital, Bologna, Università degli Studi di Ferrara, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Azienda Ospedaliera Universitaria Policlinico "G. Martino", Ospedale Policlinico San Martino, University of Rome Tor Vergata, S. Andrea Hospital, European Institute of Oncology
- Responsible party
- Sponsor
- Investigators
- Maurizio Degiuli, Professor, Principal investigator, University of Turin, Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871399
- Sponsor's protocol ID
- N.110/2019/U
- Acronym
- CoME-In
- Status last verified
- Sep 2022
- First submitted
- 23 Apr 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bertelsen CA. Complete mesocolic excision an assessment of feasibility and outcome. Dan Med J. 2017 Feb;64(2):B5334.
PubMed 28157065Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Benz S, Tannapfel A, Tam Y, Grunenwald A, Vollmer S, Stricker I. Proposal of a new classification system for complete mesocolic excison in right-sided colon cancer. Tech Coloproctol. 2019 Mar;23(3):251-257. doi: 10.1007/s10151-019-01949-4. Epub 2019 Mar 5.
PubMed 30838463Johnson PM, Porter GA, Ricciardi R, Baxter NN. Increasing negative lymph node count is independently associated with improved long-term survival in stage IIIB and IIIC colon cancer. J Clin Oncol. 2006 Aug 1;24(22):3570-5. doi: 10.1200/JCO.2006.06.8866.
PubMed 16877723Galizia G, Lieto E, De Vita F, Ferraraccio F, Zamboli A, Mabilia A, Auricchio A, Castellano P, Napolitano V, Orditura M. Is complete mesocolic excision with central vascular ligation safe and effective in the surgical treatment of right-sided colon cancers? A prospective study. Int J Colorectal Dis. 2014 Jan;29(1):89-97. doi: 10.1007/s00384-013-1766-x. Epub 2013 Aug 28.
PubMed 23982425West NP, Kobayashi H, Takahashi K, Perrakis A, Weber K, Hohenberger W, Sugihara K, Quirke P. Understanding optimal colonic cancer surgery: comparison of Japanese D3 resection and European complete mesocolic excision with central vascular ligation. J Clin Oncol. 2012 May 20;30(15):1763-9. doi: 10.1200/JCO.2011.38.3992. Epub 2012 Apr 2.
PubMed 22473170Bertelsen CA, Bols B, Ingeholm P, Jansen JE, Neuenschwander AU, Vilandt J. Can the quality of colonic surgery be improved by standardization of surgical technique with complete mesocolic excision? Colorectal Dis. 2011 Oct;13(10):1123-9. doi: 10.1111/j.1463-1318.2010.02474.x.
PubMed 20969719Kim NK, Kim YW, Han YD, Cho MS, Hur H, Min BS, Lee KY. Complete mesocolic excision and central vascular ligation for colon cancer: Principle, anatomy, surgical technique, and outcomes. Surg Oncol. 2016 Sep;25(3):252-62. doi: 10.1016/j.suronc.2016.05.009. Epub 2016 May 20.
PubMed 27566031Degiuli M, Aguilar AHR, Solej M, Azzolina D, Marchiori G, Corcione F, Bracale U, Peltrini R, Di Nuzzo MM, Baldazzi G, Cassini D, Sica GS, Pirozzi B, Muratore A, Calabro M, Jovine E, Lombardi R, Anania G, Chiozza M, Petz W, Pizzini P, Persiani R, Biondi A, Reddavid R. A Randomized Phase III Trial of Complete Mesocolic Excision Compared with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-in trial). Ann Surg Oncol. 2024 Mar;31(3):1671-1680. doi: 10.1245/s10434-023-14664-0. Epub 2023 Dec 12.
PubMed 38087139
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Mesocolic Excision With Central Vascular Ligation in Comparison With Conventional Surgery for the Right Colon Cancer: An Italian Randomized Trial
- ClinicalTrials.gov ID
- NCT04871399
- Acronym / sponsor ID
- CoME-In / N.110/2019/U
- Conditions
- Colon Cancer
- Keywords
- colon cancer, Right colon cancer, Complete mesocolic excision, CME, Right Hemicolectomy, Right Colectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Federico II University, Agnelli Hospital, Italy, Ospedale della Misericordia, Candiolo Cancer Institute - IRCCS, Maggiore Bellaria Hospital, Bologna, Università degli Studi di Ferrara, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Azienda Ospedaliera Universitaria Policlinico "G. Martino", Ospedale Policlinico San Martino, University of Rome Tor Vergata, S. Andrea Hospital, European Institute of Oncology
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 4 May 2021 (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.
An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy.
Detailed description
This study aims to compare the Complete Mesocolic Excision With Central Vascular Ligation (CME+CVL) with the standard (non-CME) right hemicolectomy in patients with right or proximal transverse colon cancer stage II-IV(AJCC 8th edition) to determine the short and long term outcomes in terms of disease-free survival (DFS) as a primary endpoint, and safety, oncologic outcomes, quality of surgery and quality of life (QoL) as secondary endpoints.
Eligible patients will be randomized with a 1:1 ratio between CME + CVL vs standard non-CME right colectomy. The randomization sequence will be generated centrally by a computed algorithm and kept concealed to investigators.
The Right colectomy with CME + CVL includes the removal of the accessory lymphovascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia. Despite the surgical approach and the type of procedure adopted, the operation should be strictly conducted following the general rules for colorectal oncologic resection, particularly as concerns proximal and distal margins length and lymph node retrieval.
All surgical approaches (open, laparoscopic, or robotic) will be allowed while the type of anastomosis performed and drain placement will be up to the surgeon's discretion.
Demographic, baseline, perioperative and postoperative characteristics will be analyzed as well.
The study expected to last six and a half years, of which one and a half years for recruiting 416 patients, 208 each arm, with five years of follow-up. Patients will be followed up at 1, 4, 12, 24, 36, and 60 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Right hemicolectomy (Non-CME) | Active comparator | Procedure: Conventional Right hemicolectomy (Non-CME)Patients will undergo conventional non-CME procedure. |
| Right hemicolectomy with CME+CVL | Experimental | Procedure: Right hemicolectomy with CME+CVLPatients will undergo Right hemicolectomy CME+CVL procedure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists(ASA) grade I-III.
- Right colon cancer (*The right-sided location of the cancer is defined as the location from the caecum up to the proximal third of the transverse colon), preoperative assessment of tumor stage T2-T4a, any N or T any N+ according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015); no distant metastasis.
- Informed consent
Key exclusion criteria (12 listed)
- Age > 85 years old.
- T1, N0
- T4b, any N
- BMI > 30.
- Metastatic disease (Abdominal and chest CT scan will be mandatory to exclude distant metastasis.)
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 |
|---|---|---|
| Conventional Right hemicolectomy (Non-CME)Transecting the Ileocolic Vein and Artery close to the Superior Mesenteric Vessels without clearing the superior mesenteric vein (SMV) from the adipose tissue. Transecting the Right Colic Vein and Artery and superior right colic vein (when present) peripherally. Transecting the Right branches of the Middle Colic Vein (MCV) and the Middle Colic Artery (MCA) peripherally, without clearing the main trunk of the MCV and the MCA. The Right Gastroepiploic Vein and artery are never transacted. | Procedure or surgery | Conventional Right hemicolectomy (Non-CME) |
| Right hemicolectomy with CME+CVLSeparation of the visceral fascia from the parietal fascia by sharp dissection leaving intact mesocolon coverage. Transecting the supplying vessels at their origin from the main vessels, particularly: * The Ileocolic Vessels, The Right Colic Vessels,The superior right colic vein (when present), The Right branches of the Middle Colic Vein and of the Middle Colic Artery * The MCV and MCA at their origin in case of cancer of the hepatic flexure or of the proximal third of the transverse colon, as well as The Right Gastroepiploic Vessels at their origin from the gastrocolic trunk of Henle (GCTH) and the gastroduodenal artery. The SMV should be cleared from all adipose tissue all along its anterior surface until its intrapancreatic entrance. | Procedure or surgery | Right hemicolectomy with CME+CVL |
Primary outcome
Disease-free survival at 3 years
Time frame: 3 Years.
The length of time after surgery without any signs or symptoms of local or distant recurrence.
12 secondary outcomes
Safety-Operative time.
Time frame: Intraoperative
Safety-Intraoperative blood loss.
Time frame: Intraoperative
Safety-Intraoperative blood transfusion.
Time frame: Intraoperative
Safety- Intraoperative Complications.
Time frame: Intraoperative
Early postoperative complications.
Time frame: 30 postoperative days.
Late postoperative complications.
Time frame: From the 31st postoperative days to the end of the study.
Safety- Length of stay.
Time frame: 30 Days.
Safety- Postoperative mortality rate.
Time frame: 30 Days.
Overall Survival at 3 years
Time frame: 3 Years.
Overall Survival at 5 years.
Time frame: 5 Years.
Disease-free survival.
Time frame: 5 Years.
Other Oncologic outcomes.
Time frame: 30 Days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Background: PubMed 28157065Bertelsen CA. Complete mesocolic excision an assessment of feasibility and outcome. Dan Med J. 2017 Feb;64(2):B5334.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 30838463Benz S, Tannapfel A, Tam Y, Grunenwald A, Vollmer S, Stricker I. Proposal of a new classification system for complete mesocolic excison in right-sided colon cancer. Tech Coloproctol. 2019 Mar;23(3):251-257. doi: 10.1007/s10151-019-01949-4. Epub 2019 Mar 5.
- Background: PubMed 16877723Johnson PM, Porter GA, Ricciardi R, Baxter NN. Increasing negative lymph node count is independently associated with improved long-term survival in stage IIIB and IIIC colon cancer. J Clin Oncol. 2006 Aug 1;24(22):3570-5. doi: 10.1200/JCO.2006.06.8866.
- Background: PubMed 23982425Galizia G, Lieto E, De Vita F, Ferraraccio F, Zamboli A, Mabilia A, Auricchio A, Castellano P, Napolitano V, Orditura M. Is complete mesocolic excision with central vascular ligation safe and effective in the surgical treatment of right-sided colon cancers? A prospective study. Int J Colorectal Dis. 2014 Jan;29(1):89-97. doi: 10.1007/s00384-013-1766-x. Epub 2013 Aug 28.
- Background: PubMed 22473170West NP, Kobayashi H, Takahashi K, Perrakis A, Weber K, Hohenberger W, Sugihara K, Quirke P. Understanding optimal colonic cancer surgery: comparison of Japanese D3 resection and European complete mesocolic excision with central vascular ligation. J Clin Oncol. 2012 May 20;30(15):1763-9. doi: 10.1200/JCO.2011.38.3992. Epub 2012 Apr 2.
- Background: PubMed 20969719Bertelsen CA, Bols B, Ingeholm P, Jansen JE, Neuenschwander AU, Vilandt J. Can the quality of colonic surgery be improved by standardization of surgical technique with complete mesocolic excision? Colorectal Dis. 2011 Oct;13(10):1123-9. doi: 10.1111/j.1463-1318.2010.02474.x.
- Background: PubMed 27566031Kim NK, Kim YW, Han YD, Cho MS, Hur H, Min BS, Lee KY. Complete mesocolic excision and central vascular ligation for colon cancer: Principle, anatomy, surgical technique, and outcomes. Surg Oncol. 2016 Sep;25(3):252-62. doi: 10.1016/j.suronc.2016.05.009. Epub 2016 May 20.
- Derived from this study: PubMed 38087139Degiuli M, Aguilar AHR, Solej M, Azzolina D, Marchiori G, Corcione F, Bracale U, Peltrini R, Di Nuzzo MM, Baldazzi G, Cassini D, Sica GS, Pirozzi B, Muratore A, Calabro M, Jovine E, Lombardi R, Anania G, Chiozza M, Petz W, Pizzini P, Persiani R, Biondi A, Reddavid R. A Randomized Phase III Trial of Complete Mesocolic Excision Compared with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-in trial). Ann Surg Oncol. 2024 Mar;31(3):1671-1680. doi: 10.1245/s10434-023-14664-0. Epub 2023 Dec 12.
- Individual participant dataSharing planned: No
Related trials for Colon Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
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.
Maurizio Degiuli, Professor principal investigator
University of Turin, Department of Oncology
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Right hemicolectomy (Non-CME) and Right hemicolectomy with CME+CVL in people with Colon Cancer, run by University of Turin, Italy at 14 sites in Italy.
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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Solej, MD (00393388624939, mariosolej@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival at 3 years (time frame: 3 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 NCT04871399, which also lists 9 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 14 Nov 2022.