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

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

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. Requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience with evaluation of non-edited video-recordings of procedures. Routine quality control includes requirement to photograph vessels with the clip to determine the extent of lymph node dissection performed and a thorough morphological assessment of the specimen. After surgery patients are treated according to local standards with no difference wether D2 or D3 lymph node dissection was performed. Short-term and long-term outcomes are registered as per protocol. This is a superiority trial evaluating statistical superiority. With the 50% five year survival according to national registry for colon cancer, expecting 10% improvement in survival with D3 lymph node dissection, enrollment of 768 patients during 3 year accrual period followed by 5 year follow up is required for a power of 80%. The intent-to-treat principle is used for the data analysis.

Complex of parameters describing the pattern of recovery after surgery (i.e. food tolerance, peristalsis, walking etc.)

Number of lymph node with metastases related to number of lymph nodes studied in each group in the specimen

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

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

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.

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.