Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 5155 for:    colon cancer

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200834
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Donetsk National Medical University
Information provided by (Responsible Party):
G.V. Bondar Republican Cancer Center

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

Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: Right Hemicolectomy with D2 lymph node dissection Procedure: Right Hemicolectomy with D3 lymph node dissection Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of D2 vs D3 Lymph Node Dissection for Right Colon Cancer (RICON)
Actual Study Start Date : January 25, 2017
Estimated Primary Completion Date : January 25, 2022
Estimated Study Completion Date : January 25, 2025

Arm Intervention/treatment
Active Comparator: D2 lymph node dissection for right colon cancer
Hemicolectomy for right colon cancer with D2 lymph node dissection
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).

Experimental: D3 lymph node dissection for right colon cancer
Hemicolectomy for right colon cancer with D3 lymph node dissection
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).




Primary Outcome Measures :
  1. 5-year survival [ Time Frame: Up to 5 years post-operative ]
    death from any cause


Secondary Outcome Measures :
  1. morbidity [ Time Frame: within the first 30 days after surgery ]
    postoperative complications

  2. mortality [ Time Frame: within the first 30 days after surgery ]
    death after surgery

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200834


Contacts
Layout table for location contacts
Contact: Vladimir Balaban, MD +380951055433 dr.bojiogbka@mail.ru
Contact: Mihail Mutik, MD +380505309861

Locations
Layout table for location information
Ukraine
G.V. Bondar Republican Cancer Center Recruiting
Donetsk, Ukraine
Contact: Vladimir Balaban, MD    +380951055433    dr.bojiogbka@mail.ru   
Contact: Mihail Mutik, MD    +380505309861    mihailmutik@bk.ru   
Sponsors and Collaborators
G.V. Bondar Republican Cancer Center
Donetsk National Medical University
Investigators
Layout table for investigator information
Study Director: Vladimir Basheev, PhD M.Gorky Donetsk National Medical University

Layout table for additonal information
Responsible Party: G.V. Bondar Republican Cancer Center
ClinicalTrials.gov Identifier: NCT03200834     History of Changes
Other Study ID Numbers: 0001
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by G.V. Bondar Republican Cancer Center:
Right colon cancer
D3 dissection
complete mesocolic excision
Hemicolectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases