Colon CancerNCT03200834
Comparison of D2 vs D3 Lymph Node Dissection for Right Colon Cancer (RICON)
A study testing Right Hemicolectomy with D2 lymph node dissection and Right Hemicolectomy with D3 lymph node dissection in people with Colon Cancer, run by G.V. Bondar Republican Cancer Center at 1 site in Ukraine.
Trial summary
Comparing different method of surgical technique D2 lymph node dissection vs D3 for right colon cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Right Hemicolectomy with D2 lymph node dissection and Right Hemicolectomy with D3 lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteUkraine
- Study dates
- 25 Jan 2017to 3 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Comparing different method of surgical technique D2 lymph node dissection vs D3 for right colon cancer.
- Conditions
- Colon Cancer
- Being tested
- Right Hemicolectomy with D2 lymph node dissection, Right Hemicolectomy with D3 lymph node dissection
- Keywords
- Right colon cancer, D3 dissection, complete mesocolic excision, Hemicolectomy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Hemicolectomy with D2 lymph node dissectionProcedure or surgery
Remove right part of colon with lymph node dissection №201, №202, №211, №212 (if present), №221,№222 (Japanese classification).
Right Hemicolectomy with D3 lymph node dissectionProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| D2 lymph node dissection for right colon cancer | Active comparator | Hemicolectomy for right colon cancer with D2 lymph node dissection Receives: 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 Receives: Procedure: Right Hemicolectomy with D3 lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year survival
death from any cause
Measured: Up to 5 years post-operative
Secondary outcomes (3)
morbidity
postoperative complications
Measured: within the first 30 days after surgery
mortality
death after surgery
Measured: within the first 30 days after surgery
Disease free survival 5 years after initial surgery
local and distant metastasis during 5 years after operation
Measured: Up to 5 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start25 Jan 2017
- Primary completion3 Jan 2029 (estimated)
- Study completion3 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- G.V. Bondar Republican Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Donetsk National Medical University, I.M. Sechenov First Moscow State Medical University
- Responsible party
- Sponsor
- Investigators
- Vladimir Balaban, PhD, Study director, M.Gorky Donetsk National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200834
- Sponsor's protocol ID
- 0001
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2017
- Last updated
- 26 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38956698
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of D2 vs D3 Lymph Node Dissection for Right Colon Cancer (RICON)
- ClinicalTrials.gov ID
- NCT03200834
- Acronym / sponsor ID
- 0001
- Conditions
- Colon Cancer
- Keywords
- Right colon cancer, D3 dissection, complete mesocolic excision, Hemicolectomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 239 participants (actual)
- Lead sponsor
- G.V. Bondar Republican Cancer CenterUniversity, hospital or other
- Collaborators
- Donetsk National Medical University, I.M. Sechenov First Moscow State Medical University
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 3 Jan 2029 (estimated)
- Study completion
- 3 Jan 2029 (estimated)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing different method of surgical technique D2 lymph node dissection vs D3 for right colon cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D2 lymph node dissection for right colon cancer | Active comparator | Procedure: Right Hemicolectomy with D2 lymph node dissectionHemicolectomy for right colon cancer with D2 lymph node dissection |
| D3 lymph node dissection for right colon cancer | Experimental | Procedure: Right Hemicolectomy with D3 lymph node dissectionHemicolectomy for right colon cancer with D3 lymph node dissection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right Hemicolectomy with D2 lymph node dissectionRemove right part of colon with lymph node dissection №201, №202, №211, №212 (if present), №221,№222 (Japanese classification). | Procedure or surgery | D2 lymph node dissection for right colon cancer |
| Right Hemicolectomy with D3 lymph node dissectionRemove 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). | Procedure or surgery | D3 lymph node dissection for right colon cancer |
Primary outcome
5-year survival
Time frame: Up to 5 years post-operative
death from any cause
3 secondary outcomes
morbidity
Time frame: within the first 30 days after surgery
mortality
Time frame: within the first 30 days after surgery
Disease free survival 5 years after initial surgery
Time frame: Up to 5 years post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Derived from this study: PubMed 38956698Balaban 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Balaban, PhD study director
M.Gorky Donetsk National Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right Hemicolectomy with D2 lymph node dissection and Right Hemicolectomy with D3 lymph node dissection in people with Colon Cancer, run by G.V. Bondar Republican Cancer Center at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year survival (time frame: Up to 5 years post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03200834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.