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

N/AActive Not RecruitingNCT03200834

G.V. Bondar Republican Cancer Center239 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

239

Conditions

Colon Cancer

Interventions

Right Hemicolectomy with D2 lymph node dissectionPROCEDURE

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

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

G.V. Bondar Republican Cancer Center

Donetsk, Ukraine

Outcomes

Primary Outcomes

5-year survival

death from any cause

Time frame: Up to 5 years post-operative

Secondary Outcomes

morbidity

postoperative complications

Time frame: within the first 30 days after surgery

mortality

death after surgery

Time frame: within the first 30 days after surgery

Disease free survival 5 years after initial surgery

local and distant metastasis during 5 years after operation

Time frame: Up to 5 years post-operative

Data from ClinicalTrials.gov

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