Comparison of D2 vs D3 Lymph Node Dissection for Right Colon Cancer (RICON)

March 23, 2025 updated by: G.V. Bondar Republican Cancer Center
Comparing different method of surgical technique D2 lymph node dissection vs D3 for right colon cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

239

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 Locations

  • Ukraine
      • Donetsk, Ukraine
        • G.V. Bondar Republican Cancer Center

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Agreement of the patient to participate in trial
  2. Colon cancer (only adenocarcinoma )
  3. The tumor located between the cecum and the right 1/3 of transverse colon
  4. Tumors T3,Т4а,b N0-2 (II-III stages)
  5. Tolerance of chemotherapy
  6. ECOG 0-2

Exclusion Criteria:

  1. Patients with distant metastases
  2. Tumors T1-2 (I stage)
  3. Complications of tumor (perforation and full bowel obstruction)
  4. Previous radiotherapy or chemotherapy
  5. Synchronous or metachronous tumors
  6. Women during Pregnancy or breast feeding period

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: D2 lymph node dissection for right colon cancer
Hemicolectomy for right colon cancer with D2 lymph node dissection
Procedure: Right Hemicolectomy with D2 lymph node dissection
Remove right part of colon with lymph node dissection №201, №202, №211, №212 (if present), №221,№222 (Japanese classification).
Experimental: D3 lymph node dissection for right colon cancer
Hemicolectomy for right colon cancer with D3 lymph node dissection
Procedure: Right Hemicolectomy with D3 lymph node dissection
Remove right part of colon with lymph node dissection №201, №202, № 203, №211, №212 (if present), №213 (if present) №221,№222, №223 (for hepatic flexure and proximal part of transverse colon cancer)(Japanese classification).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year survival
Time Frame: Up to 5 years post-operative
death from any cause
Up to 5 years post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morbidity
Time Frame: within the first 30 days after surgery
postoperative complications
within the first 30 days after surgery
mortality
Time Frame: within the first 30 days after surgery
death after surgery
within the first 30 days after surgery
Disease free survival 5 years after initial surgery
Time Frame: Up to 5 years post-operative
local and distant metastasis during 5 years after operation
Up to 5 years post-operative

Collaborators and Investigators

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

Sponsor

G.V. Bondar Republican Cancer Center

Collaborators

I.M. Sechenov First Moscow State Medical University
Donetsk National Medical University

Investigators

  • Study Director: Vladimir Balaban, PhD, M.Gorky Donetsk National Medical University

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)

January 25, 2017

Primary Completion (Estimated)

January 3, 2029

Study Completion (Estimated)

January 3, 2029

Study Registration Dates

First Submitted

March 25, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Estimated)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0001 (Researcher)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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