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

Trial Overview

Acronym	COLD
Number	NCT03009227
Protocol Link	https://www.dropbox.com/s/znqwxo2ygwk6kct/Protocol_COLD_1.1_eng.pdf?dl=0
Public Trial Registry Link	https://clinicaltrials.gov/ct2/show/NCT03009227
Status	Open/recruiting
Category	Colorectal Cancer - Colonic Specific
Treatment Course	Surgery

Trial Description

The design involves random allocation of eligible patients undergoing colonic resection to D3 or D2 lymph node dissection group in 1:1 ratio. A 3 year accrual period and 5 year follow up is planned. The intent-to-treat principle is used for the data analysis. Primary endpoint is overall survival

Chief Investigator

Aleksei Karachun
Professor

Profile Link

Lead Centre

National Medical Research Center named after N.N. Petrov
ul. Leningradskaya, house 68
St Petersburg
197758
Russia

Website

Collaboration and Funding

Collaborative Sites

Additional Information

Full Research Summary

Objective:	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
Aim:	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
Methods:	The design involves random allocation of eligible patients to D3 or D2 lymph node dissection group in 1:1 ratio. The extent of colonic resection itself is not influenced by the randomization and is predefined by the investigator prior to randomization. Inclusion Criteria: 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 Exclusion Criteria: 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
Reason for International Trial:	Lacking evidence on superiority of D3 lymph node dissection.