Clinical trial NCT06121089: Local Cecal Cancer - Optimization of Surgical Treatment
Official title: Study of the Oncological Outcomes of Ileocecal Resection With D3 for Cecal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colonic Neoplasms Malignant
Cecal Neoplasms
Keywords: Colorectal cancer
Segmental colonic resection
Ileocecal resection
Cecal cancer
Right hemicolectomy
Lead sponsor: Moscow Clinical Scientific Center
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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 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.

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.

Primary outcomes:
measure: Overall survival.
timeFrame: 5 years after the last patient.
measure: Disease-free survival.
timeFrame: 3 years after the last patient.
measure: Disease-free survival.
timeFrame: 5 years after the last patient.
Secondary outcomes:
measure: Postoperative morbidity.
timeFrame: The first 30 days after surgery.
measure: Postoperative mortality.
timeFrame: The first 30 days after surgery.
measure: Total number of lymph nodes removed.
timeFrame: Post-intervention at week 3.
measure: Total number of metastatic lymph nodes and correlation by group.
timeFrame: Post-intervention at week 3.
measure: Total length of removed bowel.
timeFrame: Post-intervention at week 3.
measure: Area of mesentery removed.
timeFrame: Post-intervention at week 3.
measure: Description of blood loss during the intraoperative period.
timeFrame: During the surgery.
measure: Operation time.
timeFrame: Immediately after the surgery.
measure: Conversion.
timeFrame: During the surgery.
measure: Number of days of inpatient treatment.
timeFrame: During hospitalization up to 4 weeks
Other outcomes:
measure: Determination of the number and level of lymph node involvement.
timeFrame: Period of examination before surgery.
measure: Quality of life in patients after ICR and RHC using questionnaire.
timeFrame: 30 days post-surgery.
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center
Study officials:
References: