Local Cecal Cancer - Optimization of Surgical Treatment

Colonic Neoplasms Malignant Clinical Trial

— LoCCOSTe  

Official title:

Study of the Oncological Outcomes of Ileocecal Resection With D3 for Cecal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06121089
• Other study ID #: 10/2022
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: January 2027

Study information

• Verified date: November 2023
• Source: Moscow Clinical Scientific Center
• Contact: Igor Matveev
• Phone: +7(916)182-17-46
• Email: i.matveev[@]mknc.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2027
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colonic Neoplasms Malignant
• Neoplasms

Intervention

Procedure:
• ileocecal resection with extended D3 lymphadenectomy.
Laparoscopy ileocecal resectionith extended D3 lymphadenectomy including 201, 202, 203 and 213 groups of lymph nodes. Manual double-row ileo-ascendo-anastomosis.
• Right hemicolectomy with D3 lymphadenectomy.
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.

Locations

Country	Name	City	State
Russian Federation	Moscow Clinical Scientific Center	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Moscow Clinical Scientific Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determination of the number and level of lymph node involvement.	X-ray assessment (Node-RADS classification) of clinical stage (N0 or N+) and distribution of suspicious lymph nodes into groups.	Period of examination before surgery.
Other	Quality of life in patients after ICR and RHC using questionnaire.	Questionnaires by European Organization for Research and Treatment of Cancer. EORTC QLQ - CR29.	30 days post-surgery.
Primary	Overall survival.	Overall survival of patients.	5 years after the last patient.
Primary	Disease-free survival.	Survival without local or distant recurrence.	3 years after the last patient.
Primary	Disease-free survival.	Survival without local or distant recurrence.	5 years after the last patient.
Secondary	Postoperative morbidity.	Complications after surgery.	The first 30 days after surgery.
Secondary	Postoperative mortality.	Death after surgery.	The first 30 days after surgery.
Secondary	Total number of lymph nodes removed.	Number of removed lymph nodes according to pathomorphological evaluation.	Post-intervention at week 3.
Secondary	Total number of metastatic lymph nodes and correlation by group.	The ratio of affected lymph nodes into groups (201, 202, 203, 213, 211, 212, 221 or 222-rt) depending on the type of surgical treatment. Based on pathological assessment.	Post-intervention at week 3.
Secondary	Total length of removed bowel.	Average length of removed bowel in both groups according to pathomorphological evaluation (millimeters).	Post-intervention at week 3.
Secondary	Area of mesentery removed.	Average area of the removed mesentery in each groups according to pathomorphological evaluation (square centimetre - sq.cm).	Post-intervention at week 3.
Secondary	Description of blood loss during the intraoperative period.	Average blood loss during surgery in each group (ml).	During the surgery.
Secondary	Operation time.	Average operation time for each group (minutes - min).	Immediately after the surgery.
Secondary	Conversion.	The total number of conversions for each group.	During the surgery.
Secondary	Number of days of inpatient treatment.	Average number of days of inpatient treatment.	During hospitalization up to 4 weeks