Clinical trial NCT04871399: Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer
Official title: Complete Mesocolic Excision With Central Vascular Ligation in Comparison With Conventional Surgery for the Right Colon Cancer: An Italian Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Keywords: colon cancer
Right colon cancer
Complete mesocolic excision
CME
Right Hemicolectomy
Right Colectomy
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Federico II University
name: Agnelli Hospital, Italy
name: Ospedale della Misericordia
name: Candiolo Cancer Institute - IRCCS
name: Maggiore Bellaria Hospital, Bologna
name: Università degli Studi di Ferrara
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
name: Ospedale Policlinico San Martino
name: University of Rome Tor Vergata
name: S. Andrea Hospital
name: European Institute of Oncology
First posted: 2021-05-04
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Disease-free survival at 3 years
timeFrame: 3 Years.
Secondary outcomes:
measure: Safety-Operative time.
timeFrame: Intraoperative
measure: Safety-Intraoperative blood loss.
timeFrame: Intraoperative
measure: Safety-Intraoperative blood transfusion.
timeFrame: Intraoperative
measure: Safety- Intraoperative Complications.
timeFrame: Intraoperative
measure: Early postoperative complications.
timeFrame: 30 postoperative days.
measure: Late postoperative complications.
timeFrame: From the 31st postoperative days to the end of the study.
measure: Safety- Length of stay.
timeFrame: 30 Days.
measure: Safety- Postoperative mortality rate.
timeFrame: 30 Days.
measure: Overall Survival at 3 years
timeFrame: 3 Years.
measure: Overall Survival at 5 years.
timeFrame: 5 Years.
measure: Disease-free survival.
timeFrame: 5 Years.
measure: Other Oncologic outcomes.
timeFrame: 30 Days.
Other outcomes:
Locations:
city: Grosseto
country: Italy
facility: Ospedale della Misericordia
state: Arezzo
city: Sesto San Giovanni
country: Italy
facility: Ospedale Città di Sesto San Giovanni
state: Milano
city: La Spezia
country: Italy
facility: S. Andrea Hospital
state: Spezia
city: Candiolo
country: Italy
facility: Candiolo Cancer Institute - IRCCS
state: Torino
city: Pinerolo
country: Italy
facility: Ospedale E. Agnelli Pinerolo
state: Torino
city: Bologna
country: Italy
facility: Maggiore Bellaria Hospital, Bologna
city: Ferrara
country: Italy
facility: Università degli Studi di Ferrara
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
city: Milano
country: Italy
facility: European Institute of Oncology
city: Napoli
country: Italy
facility: Federico II University
city: Rome
country: Italy
facility: University of Rome Tor Vergata
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Torino
country: Italy
facility: University of Turin (AOU.San Luigi Gonzaga)
Study officials:
affiliation: University of Turin, Department of Oncology
name: Maurizio Degiuli, Professor
role: PRINCIPAL_INVESTIGATOR
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