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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 25, 2022

Interventions

  • 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).
  • 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).

Arms, Groups and Cohorts

  • Active Comparator: D2 lymph node dissection for right colon cancer
    • Hemicolectomy for right colon cancer with D2 lymph node dissection
  • Experimental: D3 lymph node dissection for right colon cancer
    • Hemicolectomy for right colon cancer with D3 lymph node dissection

Clinical Trial Outcome Measures

Primary Measures

  • 5-year survival
    • Time Frame: Up to 5 years post-operative
    • death from any cause

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • G.V. Bondar Republican Cancer Center
  • Collaborator
    • Donetsk National Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Vladimir Basheev, PhD, Study Director, M.Gorky Donetsk National Medical University
  • Overall Contact(s)
    • Vladimir Balaban, MD, +380951055433, dr.bojiogbka@mail.ru

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