Local Cecal Cancer - Optimization of Surgical Treatment

Trial Title: Local Cecal Cancer - Optimization of Surgical Treatment

NCT ID: NCT06121089

Condition: Colonic Neoplasms Malignant
Cecal Neoplasms

Conditions: Official terms:
Neoplasms
Colonic Neoplasms
Cecal Neoplasms

Conditions: Keywords:
Colorectal cancer
Segmental colonic resection
Ileocecal resection
Cecal cancer
Right hemicolectomy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: All patients will be randomly divided into two groups in a 1:1 ratio. 1. Research group (ICR) - Laparoscopy ileocecal resection with extended D3 lymphadenectomy (including 201, 202, 203 and 213 groups of lymph nodes). The minimum distance from the tumor is 10 cm, along the line of adequate blood supply. Next step - formation of a manual double-row ileo-ascendo-anastomosis. 2. Control group (RHC) - Laparoscopy right hemicolectomy with D3 lymphadenectomy (including 211, 212, 221, 222-rt groups of lymph nodes). Next step - formation of a manual double-row ileo-transverse-anastomosis.

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Intervention:

Intervention type: Procedure
Intervention name: ileocecal resection with extended D3 lymphadenectomy.
Description: Laparoscopy ileocecal resectionith extended D3 lymphadenectomy including 201, 202, 203 and 213 groups of lymph nodes. Manual double-row ileo-ascendo-anastomosis.
Arm group label: Laparoscopy ileocecal resection with extended D3 lymphadenectomy.

Intervention type: Procedure
Intervention name: Right hemicolectomy with D3 lymphadenectomy.
Description: Laparoscopy right hemicolectomy with D3 lymphadenectomy including 201, 202, 203, 213, 211, 212, 221, 222-rt groups of lymph nodes. Manual double-row ileo-transverse-anastomosis.
Arm group label: Laparoscopy right hemicolectomy with D3 lymphadenectomy.

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 cecal cancer.

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 described in the protocol and refer to center volume and surgeon's experience. Regular quality control includes the requirement to photograph the surgical specimen with a mark to determine the extent of lymphadenectomy performed and the number of the lymph node group. After surgery patients are treated according to local standards, regardless of whether ICR or RHC was performed. Short-term and long-term outcomes are recorded according to the protocol. Intervention. In all cases the tumor is localized in the area of the cecum; the border of the transition to the ascending colon is the upper lip of the ileocecal valve. The patient is not included in the study if the preoperative stage of examination reveals: synchronous cancer, distant metastasis (M1), locally advanced nature of the primary tumor (cT > 3). All patients will be randomly divided into two groups in a 1:1 ratio. 1. Research group (ICR) - Laparoscopy ileocecal resection with extended D3 lymphadenectomy (including 201, 202, 203 and 213 groups of lymph nodes). The minimum distance from the tumor is 10 cm, along the line of adequate blood supply. Next step - formation of a manual double-row ileo-ascendo-anastomosis. 2. Control group (RHC) - Laparoscopy right hemicolectomy with D3 lymphadenectomy (including 211, 212, 221, 222-rt groups of lymph nodes). Next step - formation of a manual double-row ileo-transverse-anastomosis. Expected Results. The ICR will improve the short-term results of treatment of patients with cecal cancer compared with the standard RHC technique without affecting long-term results.

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Moscow Clinical Scientific Center

Address:
City: Moscow
Country: Russian Federation

Status: Recruiting

Contact:
Last name: Igor Matveev

Phone: +7(916)182-17-46
Email: i.matveev@mknc.ru

Start date: September 1, 2022

Completion date: January 2027

Lead sponsor:
Agency: Moscow Clinical Scientific Center
Agency class: Other

Source: Moscow Clinical Scientific Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06121089