NCT03200834

Brief Summary

Comparing different method of surgical technique D2 lymph node dissection vs D3 for right colon cancer.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
239

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress78%
Jan 2017Jan 2029

Study Start

First participant enrolled

January 25, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2029

Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

11.9 years

First QC Date

March 25, 2017

Last Update Submit

March 23, 2025

Conditions

Keywords

Right colon cancerD3 dissectioncomplete mesocolic excisionHemicolectomy

Outcome Measures

Primary Outcomes (1)

  • 5-year survival

    death from any cause

    Up to 5 years post-operative

Secondary Outcomes (3)

  • morbidity

    within the first 30 days after surgery

  • mortality

    within the first 30 days after surgery

  • Disease free survival 5 years after initial surgery

    Up to 5 years post-operative

Study Arms (2)

D2 lymph node dissection for right colon cancer

ACTIVE COMPARATOR

Hemicolectomy for right colon cancer with D2 lymph node dissection

Procedure: Right Hemicolectomy with D2 lymph node dissection

D3 lymph node dissection for right colon cancer

EXPERIMENTAL

Hemicolectomy for right colon cancer with D3 lymph node dissection

Procedure: Right Hemicolectomy with D3 lymph node dissection

Interventions

Remove right part of colon with lymph node dissection №201, №202, №211, №212 (if present), №221,№222 (Japanese classification).

D2 lymph node dissection for right colon cancer

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).

D3 lymph node dissection for right colon cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G.V. Bondar Republican Cancer Center

Donetsk, Ukraine

Location

Related Publications (1)

  • Balaban V, Mutyk M, Bondarenko N, Zolotukhin S, Sovpel O, Sovpel I, Zykov D, Rublevskiy I, Klochkov M, Prado AP, He M, Tsarkov P. Comparison of D2 vs D3 lymph node dissection for RIght COloN cancer (RICON): study protocol for an international multicenter open-label randomized controlled trial. Trials. 2024 Jul 2;25(1):438. doi: 10.1186/s13063-024-08269-5.

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Vladimir Balaban, PhD

    M.Gorky Donetsk National Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2017

First Posted

June 27, 2017

Study Start

January 25, 2017

Primary Completion (Estimated)

January 3, 2029

Study Completion (Estimated)

January 3, 2029

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations