Comparing two surgical methods for right colon cancer treatment
Complete Mesocolic Excision With Central Vascular Ligation in Comparison With Conventional Surgery for the Right Colon Cancer: An Italian Randomized Trial
This study is testing two different surgical methods for treating right colon cancer to see which one helps patients live longer and feel better after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 416 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Turin, Italy Academic / other |
| Locations | 14 sites (Grosseto, Arezzo and 13 other locations) |
| Trial ID | NCT04871399 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with stage II-IV right colon cancer who are ASA grade I-III and meet specific tumor staging criteria.
Not a fit: Patients over 85 years old, those with metastatic disease, or those with certain comorbidities will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and survival rates for patients with right colon cancer.
How similar studies have performed: Previous studies have shown promising results with similar surgical approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Grosseto, Arezzo and 13 other locations
- 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)
- Maggiore Bellaria Hospital, Bologna — Bologna, Italy (Not_yet_recruiting)
- Università degli Studi di Ferrara — Ferrara, Italy (Not_yet_recruiting)
- Ospedale Policlinico San Martino — Genova, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Universitaria Policlinico "G. Martino" — Messina, Italy (Not_yet_recruiting)
- European Institute of Oncology — Milan, Italy (Not_yet_recruiting)
- Federico II University — Naples, Italy (Not_yet_recruiting)
- University of Rome Tor Vergata — Rome, Italy (Not_yet_recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (Not_yet_recruiting)
- University of Turin (AOU.San Luigi Gonzaga) — Torino, Italy (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.