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

NCT ID: NCT03200834

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-25

Study Completion Date

2029-01-03

Brief Summary

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

Detailed Description

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Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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D2 lymph node dissection for right colon cancer

Hemicolectomy for right colon cancer with D2 lymph node dissection

Group Type ACTIVE_COMPARATOR

Right Hemicolectomy with D2 lymph node dissection

Intervention Type PROCEDURE

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

D3 lymph node dissection for right colon cancer

Hemicolectomy for right colon cancer with D3 lymph node dissection

Group Type EXPERIMENTAL

Right Hemicolectomy with D3 lymph node dissection

Intervention Type PROCEDURE

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).

Interventions

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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).

Intervention Type 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Donetsk National Medical University

OTHER

Sponsor Role collaborator

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role collaborator

G.V. Bondar Republican Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vladimir Balaban, PhD

Role: STUDY_DIRECTOR

M.Gorky Donetsk National Medical University

Locations

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G.V. Bondar Republican Cancer Center

Donetsk, , Ukraine

Site Status

Countries

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Ukraine

References

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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.

Reference Type DERIVED
PMID: 38956698 (View on PubMed)

Other Identifiers

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0001

Identifier Type: -

Identifier Source: org_study_id

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