Optimizing surgical treatment for cecal cancer
Study of the Oncological Outcomes of Ileocecal Resection With D3 for Cecal Cancer
This study is testing whether a new type of surgery for cecal cancer can work better and be safer than the standard surgery currently used.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Moscow Clinical Scientific Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06121089 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the clinical efficacy, safety, and oncologic outcomes of ileocecal resection (ICR) with D3 lymphadenectomy compared to standard right hemicolectomy (RHC) for patients with cecal cancer. Eligible patients will be randomly assigned to either the ICR or RHC group in a 1:1 ratio. The study includes strict quality control measures, such as photographing surgical specimens to assess lymphadenectomy extent. Outcomes will be monitored post-surgery according to local standards, regardless of the surgical approach used.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed adenocarcinoma of the colon at clinical stage T1-3, N+, M0.
Not a fit: Patients with synchronous malignancies, locally advanced tumors, or distant metastases 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 cecal cancer.
How similar studies have performed: Other 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: * At least 18 years of age. * ECOG status 0-2. * Histologically confirmed adenocarcinoma of the colon. * Clinical stage T1-3; N+; M0. * The physical status from ASA classification I, II, III or IV. * Written informed consent. Exclusion Criteria: * Synchronous or metachronous malignancy. * Locally-advanced tumor (T\>3). * Presence of distant metastases (M1). * Complicated tumor: obstruction, perforation. * Neoadjuvant chemotherapy. * Medical contraindications for surgical treatment. * Pregnancy or breast feeding. * Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol.
Where this trial is running
Moscow
- Moscow Clinical Scientific Center — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Igor Matveev
- Email: i.matveev@mknc.ru
- Phone: +7(916)182-17-46
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.