Comparing two surgical methods for right colon cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare Complete Mesocolic Excision with Central Vascular Ligation (CME+CVL) against standard right hemicolectomy in patients with right or proximal transverse colon cancer. Eligible participants will be randomly assigned to one of the two surgical approaches to evaluate differences in disease-free survival, safety, oncologic outcomes, quality of surgery, and quality of life. The study will include various surgical techniques such as open, laparoscopic, or robotic methods, and will analyze a range of demographic and clinical characteristics over a period of six and a half years.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Turin (AOU.San Luigi Gonzaga)
  Torino, Italy Recruiting
• Ospedale della Misericordia
  Grosseto, Arezzo, Italy Not yet recruiting
• Ospedale Città di Sesto San Giovanni
  Sesto San Giovanni, Milano, Italy Not yet recruiting
• S. Andrea Hospital
  La Spezia, Spezia, Italy Not yet recruiting
• Candiolo Cancer Institute - IRCCS
  Candiolo, Torino, Italy Not yet recruiting
• Ospedale E. Agnelli Pinerolo
  Pinerolo, Torino, Italy Not yet recruiting

Study contacts

• Principal investigator: Maurizio Degiuli, Professor — University of Turin, Department of Oncology
• Study coordinator: Mario Solej, MD
• Email: mariosolej@gmail.com
• Phone: 00393388624939

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.