Status:
RECRUITING
Local Cecal Cancer - Optimization of Surgical Treatment
Lead Sponsor:
Moscow Clinical Scientific Center
Conditions:
Colonic Neoplasms Malignant
Cecal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the clinical efficacy, safety, and oncologic outcomes of ileocecal resection (ICR) with D3 lymphadenectomy compared to standard right hemicolectomy(RHC) for c...
Detailed Description
The design involves random allocation of eligible patients to ICR or RHC group in 1:1 ratio. Requirements applied to centers participating in the trial and surgeons performing procedures are describe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06121089
Start Date
September 1 2022
End Date
January 1 2027
Last Update
November 18 2023
Active Locations (1)
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1
Moscow Clinical Scientific Center
Moscow, Russia