Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer

NCT03009227 | Unknown

• 1 other identifier: COL-1
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to determine wether D3 lymph node dissection gives superior oncological outcomes compared to standard D2 lymph node dissection in colon cancer

Conditions

Colonic Neoplasms Malignant

Keywords

colon cancer; lymph node dissection; D3 lymph node dissection

Outcome Measures

Primary Outcomes (1)

• Overall survival

  overall survival of patients

  5 years after last patient enrolled

Secondary Outcomes (8)

• Disease-free survival

  5 years after last patient enrolled

• Postoperative morbidity

  within the first 30 days after surgery

• Postoperative mortality

  within the first 30 days after surgery

• Postoperative recovery parameters

  within the first 30 days after surgery

• Pattern of lymph node metastasis based on pathology report

  enrollment period

Study Arms (2)

D2 lymph node dissection

ACTIVE COMPARATOR

Colonic resection with D2 lymph node dissection

Procedure: Colonic resection with D2 lymph node dissection

D3 lymph node dissection

EXPERIMENTAL

Colonic resection with D3 lymph node dissection

Procedure: Colonic resection with D3 lymph node dissection

Interventions

Colonic resection with D2 lymph node dissection PROCEDURE

Appropriate to the tumor location colonic resection is performed with D2 lymph node dissection

D2 lymph node dissection

Colonic resection with D3 lymph node dissection PROCEDURE

Appropriate to the tumor location colonic resection is performed with D3 lymph node dissection

D3 lymph node dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid)
• clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
• indications for surgical colonic resection
• ECOG status 0-2
• At least 18 years of age
• Written informed consent

You may not qualify if:

• Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
• Pregnancy or breast feeding
• Medical contraindications for surgical treatment
• Synchronous or metachronous malignancy
• Non-resectable distant metastases
• Colon obstruction, perforation or bleeding complicating the tumor
• Indications for isolated transverse colon resection
• Neoadjuvant chemotherapy

Sponsors & Collaborators

• N.N. Petrov National Medical Research Center of Oncology: lead

Study Sites (12)

Krasnodar City clinical hospital #1

Krasnodar, 350000, Russia

Location

State Scientific Centre of Coloproctology

Moscow, 123423, Russia

Location

Moscow city oncological hospital #62

Moscow, 125130, Russia

Location

P. Herzen Moscow Oncology Research Institute

Moscow, 125284, Russia

Location

Medical radiological scientific center named after A.F. Tsyba

Obninsk, 450054, Russia

Location

Rostov Research Institute of Oncology

Rostov, 344037, Russia

Location

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, 197022, Russia

Location

St Petersburg City Clinical Oncology Dispensary

Saint Petersburg, 197022, Russia

Location

Saint-Petersburg Clinical Research center of specialized kinds of medical care (Oncology)

Saint Petersburg, 197758, Russia

Location

Scientific-Research institute of Oncology named after N.N. Petrov

Saint Petersburg, 197758, Russia

Location

Saint-Petersburg State University Clinic

Saint Petersburg, 198103, Russia

Location

Republican clinical oncological dispencery

Ufa, 450054, Russia

Location

Related Publications (2)

• Karachun A, Petrov A, Panaiotti L, Voschinin Y, Ovchinnikova T. Protocol for a multicentre randomized clinical trial comparing oncological outcomes of D2 versus D3 lymph node dissection in colonic cancer (COLD trial). BJS Open. 2019 Mar 14;3(3):288-298. doi: 10.1002/bjs5.50142. eCollection 2019 Jun.

  PMID: 31183444 BACKGROUND

• Karachun A, Panaiotti L, Chernikovskiy I, Achkasov S, Gevorkyan Y, Savanovich N, Sharygin G, Markushin L, Sushkov O, Aleshin D, Shakhmatov D, Nazarov I, Muratov I, Maynovskaya O, Olkina A, Lankov T, Ovchinnikova T, Kharagezov D, Kaymakchi D, Milakin A, Petrov A. Short-term outcomes of a multicentre randomized clinical trial comparing D2 versus D3 lymph node dissection for colonic cancer (COLD trial). Br J Surg. 2020 Apr;107(5):499-508. doi: 10.1002/bjs.11387. Epub 2019 Dec 24.

  PMID: 31872869 RESULT

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Aleksei Karachun, Ph.D.

  N.N. Petrov Research Institute of Oncology, Surgical department of abdominal oncology, St. Petersburg, Russian Federation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 4, 2017
• Study Start: February 3, 2017
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (12)