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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D2 lymph node dissection | Active Comparator | Colonic resection with D2 lymph node dissection |
|
| D3 lymph node dissection | Experimental | Colonic resection with D3 lymph node dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonic resection with D2 lymph node dissection | Procedure | Appropriate to the tumor location colonic resection is performed with D2 lymph node dissection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | overall survival of patients | 5 years after last patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | Survival without local or systemic recurrence | 5 years after last patient enrolled |
| Postoperative morbidity | Complications after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aleksei Karachun, Ph.D. | N.N. Petrov Research Institute of Oncology, Surgical department of abdominal oncology, St. Petersburg, Russian Federation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krasnodar City clinical hospital #1 | Krasnodar | 350000 | Russia | |||
| State Scientific Centre of Coloproctology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31183444 | Background | 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. | |
| 31872869 | Result |
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We are not planning to share personal patient data
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| Colonic resection with D3 lymph node dissection | Procedure | Appropriate to the tumor location colonic resection is performed with D3 lymph node dissection |
|
| within the first 30 days after surgery |
| Postoperative mortality | Death after surgery | within the first 30 days after surgery |
| Postoperative recovery parameters | Complex of parameters describing the pattern of recovery after surgery (i.e. food tolerance, peristalsis, walking etc.) | within the first 30 days after surgery |
| Pattern of lymph node metastasis based on pathology report | Number of lymph node with metastases related to number of lymph nodes studied in each group in the specimen | enrollment period |
| CME quality | Ratio of good, satisfactory and unsatisfactory quality according to pathology report | enrollment period |
| Lymph node yield | Number of lymph nodes removed according to pathology report | enrollment period |
| Quality of life in patients after D2 and D3 lymph node dissection using questionnaire | CR29 and CR30 questionnaires by European Organization for Research and Treatment of Cancer | enrollment period |
| Moscow |
| 123423 |
| Russia |
| Moscow city oncological hospital #62 | Moscow | 125130 | Russia |
| P. Herzen Moscow Oncology Research Institute | Moscow | 125284 | Russia |
| Medical radiological scientific center named after A.F. Tsyba | Obninsk | 450054 | Russia |
| Rostov Research Institute of Oncology | Rostov-on-Don | 344037 | Russia |
| Pavlov First Saint Petersburg State Medical University | Saint Petersburg | 197022 | Russia |
| St Petersburg City Clinical Oncology Dispensary | Saint Petersburg | 197022 | Russia |
| Saint-Petersburg Clinical Research center of specialized kinds of medical care (Oncology) | Saint Petersburg | 197758 | Russia |
| Scientific-Research institute of Oncology named after N.N. Petrov | Saint Petersburg | 197758 | Russia |
| Saint-Petersburg State University Clinic | Saint Petersburg | 198103 | Russia |
| Republican clinical oncological dispencery | Ufa | 450054 | Russia |
| 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. |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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