Back to resultsComparison of D2 vs D3 Lymph Node Dissection for Right Colon Cancer (RICON)
Primary Purpose
Colon Cancer
Status
Active
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Right Hemicolectomy with D2 lymph node dissection
Right Hemicolectomy with D3 lymph node dissection
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer focused on measuring Right colon cancer, D3 dissection, complete mesocolic excision, Hemicolectomy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- G.V. Bondar Republican Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
D2 lymph node dissection for right colon cancer
D3 lymph node dissection for right colon cancer
Arm Description
Hemicolectomy for right colon cancer with D2 lymph node dissection
Hemicolectomy for right colon cancer with D3 lymph node dissection
Outcomes
Primary Outcome Measures
5-year survival
death from any cause
Secondary Outcome Measures
morbidity
postoperative complications
mortality
death after surgery
Disease free survival 5 years after initial surgery
local and distant metastasis during 5 years after operation
Full Information
NCT ID
NCT03200834
First Posted
March 25, 2017
Last Updated
September 11, 2023
Sponsor
G.V. Bondar Republican Cancer Center
Collaborators
Donetsk National Medical University, I.M. Sechenov First Moscow State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03200834
Brief Title
Comparison of D2 vs D3 Lymph Node Dissection for Right Colon Cancer (RICON)
Official Title
Comparison of D2 vs D3 Lymph Node Dissection for Right Colon Cancer (RICON)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 25, 2017 (Actual)
Primary Completion Date
January 3, 2029 (Anticipated)
Study Completion Date
January 3, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
G.V. Bondar Republican Cancer Center
Collaborators
Donetsk National Medical University, I.M. Sechenov First Moscow State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Comparing different method of surgical technique D2 lymph node dissection vs D3 for right colon cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Right colon cancer, D3 dissection, complete mesocolic excision, Hemicolectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D2 lymph node dissection for right colon cancer
Arm Type
Active Comparator
Arm Description
Hemicolectomy for right colon cancer with D2 lymph node dissection
Arm Title
D3 lymph node dissection for right colon cancer
Arm Type
Experimental
Arm Description
Hemicolectomy for right colon cancer with D3 lymph node dissection
Intervention Type
Procedure
Intervention Name(s)
Right Hemicolectomy with D2 lymph node dissection
Intervention Description
Remove right part of colon with lymph node dissection №201, №202, №211, №212 (if present), №221,№222 (Japanese classification).
Intervention Type
Procedure
Intervention Name(s)
Right Hemicolectomy with D3 lymph node dissection
Intervention Description
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).
Primary Outcome Measure Information:
Title
5-year survival
Description
death from any cause
Time Frame
Up to 5 years post-operative
Secondary Outcome Measure Information:
Title
morbidity
Description
postoperative complications
Time Frame
within the first 30 days after surgery
Title
mortality
Description
death after surgery
Time Frame
within the first 30 days after surgery
Title
Disease free survival 5 years after initial surgery
Description
local and distant metastasis during 5 years after operation
Time Frame
Up to 5 years post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Basheev, PhD
Organizational Affiliation
M.Gorky Donetsk National Medical University
Official's Role
Study Director
Facility Information:
Facility Name
G.V. Bondar Republican Cancer Center
City
Donetsk
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of D2 vs D3 Lymph Node Dissection for Right Colon Cancer (RICON)
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