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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03200834
• Other study ID #: 0001
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 25, 2017
• Est. completion date: January 3, 2029

Study information

• Verified date: November 2023
• Source: G.V. Bondar Republican Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 239
• Est. completion date: January 3, 2029
• Est. primary completion date: January 3, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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,?4?,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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

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).
• 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).

Locations

Country	Name	City	State
Ukraine	G.V. Bondar Republican Cancer Center	Donetsk

Sponsors (3)

Lead Sponsor	Collaborator
G.V. Bondar Republican Cancer Center	Donetsk National Medical University, I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year survival	death from any cause	Up to 5 years post-operative
Secondary	morbidity	postoperative complications	within the first 30 days after surgery
Secondary	mortality	death after surgery	within the first 30 days after surgery
Secondary	Disease free survival 5 years after initial surgery	local and distant metastasis during 5 years after operation	Up to 5 years post-operative