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
| 1. National Medical Research Center of Oncology named after N.N. Petrov 68 Leningradskaya street Saint-Petersburg 197758 Russia Contact: Aleksei Karachun |
| 2. State Scientific Centre of Coloproctology Ulitsa Salyama Adilya, 2 Moscow 123423 Russia Contact: Segei Achkasov |
| 3. Saint-Petersburg Clinical Research center of specialized kinds of medical care (Oncology) 68A Leningradskaya street Saint-Petersburg 197758 Russia Contact: Ilya Chernikovskiy |
| 4. Rostov Research Institute of Oncology Ulitsa 14 Liniya, 63 Rostov 344037 Russia Contact: Yuriy Gevorkyan |
| 5. P. Herzen Moscow Oncology Research Institute 2-Y Botkinskiy Proyezd, 3 Moscow 125284 Russia Contact: Dmitrii Sidorov |
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. |