NCT06121089

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Sep 2022Jan 2027

Study Start

First participant enrolled

September 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.3 years

First QC Date

October 25, 2023

Last Update Submit

November 14, 2023

Conditions

Colonic Neoplasms MalignantCecal Neoplasms

Keywords

Colorectal cancerSegmental colonic resectionIleocecal resectionCecal cancerRight hemicolectomy

Outcome Measures

Primary Outcomes (3)

  • Overall survival.

    Overall survival of patients.

    5 years after the last patient.

  • Disease-free survival.

    Survival without local or distant recurrence.

    3 years after the last patient.

  • Disease-free survival.

    Survival without local or distant recurrence.

    5 years after the last patient.

Secondary Outcomes (10)

  • Postoperative morbidity.

    The first 30 days after surgery.

  • Postoperative mortality.

    The first 30 days after surgery.

  • Total number of lymph nodes removed.

    Post-intervention at week 3.

  • Total number of metastatic lymph nodes and correlation by group.

    Post-intervention at week 3.

  • Total length of removed bowel.

    Post-intervention at week 3.

  • +5 more secondary outcomes

Other Outcomes (2)

  • Determination of the number and level of lymph node involvement.

    Period of examination before surgery.

  • Quality of life in patients after ICR and RHC using questionnaire.

    30 days post-surgery.

Study Arms (2)

Laparoscopy ileocecal resection with extended D3 lymphadenectomy.

ACTIVE COMPARATOR

Ileocecal resection with extended D3 lymphadenectomy.

Procedure: ileocecal resection with extended D3 lymphadenectomy.

Laparoscopy right hemicolectomy with D3 lymphadenectomy.

EXPERIMENTAL

Right hemicolectomy with D3 lymphadenectomy

Procedure: Right hemicolectomy with D3 lymphadenectomy.

Interventions

ileocecal resection with extended D3 lymphadenectomy.PROCEDURE

Laparoscopy ileocecal resectionith extended D3 lymphadenectomy including 201, 202, 203 and 213 groups of lymph nodes. Manual double-row ileo-ascendo-anastomosis.

Laparoscopy ileocecal resection with extended D3 lymphadenectomy.
Right hemicolectomy with D3 lymphadenectomy.PROCEDURE

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.

Laparoscopy right hemicolectomy with D3 lymphadenectomy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moscow Clinical Scientific Center

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Cecal NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesCecal DiseasesIntestinal DiseasesColonic DiseasesRectal Diseases

Central Study Contacts

Igor Matveev

CONTACT

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

Mikhail Danilov

CONTACT

+7(967) 136-76-87m.danilov@mknc.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

November 7, 2023

Study Start

September 1, 2022

Primary Completion

January 1, 2025

Study Completion (Estimated)

January 1, 2027

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

We are not planning to share personal patient data.

Locations

RU(1)