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

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

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

Conditions
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Colon Cancer

Intervention / Treatment
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* Procedure: Right Hemicolectomy with D2 lymph node dissection
* Procedure: Right Hemicolectomy with D3 lymph node dissection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D2 lymph node dissection for right colon cancer<br>Hemicolectomy for right colon cancer with D2 lymph node dissection | Procedure: Right Hemicolectomy with D2 lymph node dissection<br>* Remove right part of colon with lymph node dissection №201, №202, №211, №212 (if present), №221,№222 (Japanese classification).<br>|
| Experimental: D3 lymph node dissection for right colon cancer<br>Hemicolectomy for right colon cancer with D3 lymph node dissection | Procedure: Right Hemicolectomy with D3 lymph node dissection<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year survival | death from any cause | Up to 5 years post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity | postoperative complications | within the first 30 days after surgery | 
| mortality | death after surgery | within the first 30 days after surgery | 
| Disease free survival 5 years after initial surgery | local and distant metastasis during 5 years after operation | Up to 5 years post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Right colon cancer, D3 dissection, complete mesocolic excision, Hemicolectomy