Local Cecal Cancer - Optimization of Surgical Treatment (LoCCOSTe)

November 14, 2023 updated by: Moscow Clinical Scientific Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopy ileocecal resection with extended D3 lymphadenectomy.
Ileocecal resection with extended D3 lymphadenectomy.
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.
Experimental: Laparoscopy right hemicolectomy with D3 lymphadenectomy.
Right hemicolectomy with D3 lymphadenectomy
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival.
Time Frame: 5 years after the last patient.
Overall survival of patients.
5 years after the last patient.
Disease-free survival.
Time Frame: 3 years after the last patient.
Survival without local or distant recurrence.
3 years after the last patient.
Disease-free survival.
Time Frame: 5 years after the last patient.
Survival without local or distant recurrence.
5 years after the last patient.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morbidity.
Time Frame: The first 30 days after surgery.
Complications after surgery.
The first 30 days after surgery.
Postoperative mortality.
Time Frame: The first 30 days after surgery.
Death after surgery.
The first 30 days after surgery.
Total number of lymph nodes removed.
Time Frame: Post-intervention at week 3.
Number of removed lymph nodes according to pathomorphological evaluation.
Post-intervention at week 3.
Total number of metastatic lymph nodes and correlation by group.
Time Frame: Post-intervention at week 3.
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.
Total length of removed bowel.
Time Frame: Post-intervention at week 3.
Average length of removed bowel in both groups according to pathomorphological evaluation (millimeters).
Post-intervention at week 3.
Area of mesentery removed.
Time Frame: Post-intervention at week 3.
Average area of the removed mesentery in each groups according to pathomorphological evaluation (square centimetre - sq.cm).
Post-intervention at week 3.
Description of blood loss during the intraoperative period.
Time Frame: During the surgery.
Average blood loss during surgery in each group (ml).
During the surgery.
Operation time.
Time Frame: Immediately after the surgery.
Average operation time for each group (minutes - min).
Immediately after the surgery.
Conversion.
Time Frame: During the surgery.
The total number of conversions for each group.
During the surgery.
Number of days of inpatient treatment.
Time Frame: During hospitalization up to 4 weeks
Average number of days of inpatient treatment.
During hospitalization up to 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of the number and level of lymph node involvement.
Time Frame: Period of examination before surgery.
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.
Quality of life in patients after ICR and RHC using questionnaire.
Time Frame: 30 days post-surgery.
Questionnaires by European Organization for Research and Treatment of Cancer. EORTC QLQ - CR29.
30 days post-surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moscow Clinical Scientific Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

November 5, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are not planning to share personal patient data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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