Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer (COLD)
|Colonic Neoplasms Malignant||Procedure: Colonic resection with D2 lymph node dissection Procedure: Colonic resection with D3 lymph node dissection|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer|
- Overall survival [ Time Frame: 5 years after last patient enrolled ]
- Disease-free survival [ Time Frame: 5 years after last patient enrolled ]
- Postoperative morbidity [ Time Frame: within the first 30 days after surgery ]
- Postoperative mortality [ Time Frame: within the first 30 days after surgery ]
- Postoperative recovery parameters [ Time Frame: within the first 30 days after surgery ]Complex of parameters describing the pattern of recovery after surgery (i.e. food tolerance, peristalsis, walking etc.)
- Open and laparoscopic interventions ratio [ Time Frame: enrollment period ]
- Pattern of lymph node metastasis based on pathology report [ Time Frame: enrollment period ]Number of lymph node with metastases related to number of lymph nodes studied in each group in the specimen
- Complete mesocolic excision quality in open and laparoscopic procedures based on pathology report [ Time Frame: enrollment period ]Plane of dissection will be described by pathology report (mesocolic plane, intramesocolic plan and muscular is propria plane), determing the quality of complete mesocolic excision.
- Lymph node dissection quality in open and laparoscopic procedures based on surgery report and attached photos [ Time Frame: enrollment period ]Percentage of cases, in which the desired level of dissection was achieved in open and laparoscopic procedures will be compared
- Quality of life in patients after D2 and D3 lymph node dissection using questionnaire [ Time Frame: enrollment period ]CR29 and CR30 questionnaires by European Organization for Research and Treatment of Cancer
|Study Start Date:||January 2017|
|Estimated Study Completion Date:||January 2025|
|Estimated Primary Completion Date:||January 2025 (Final data collection date for primary outcome measure)|
Active Comparator: D2 lymph node dissection
Colonic resection with D2 lymph node dissection
Procedure: Colonic resection with D2 lymph node dissection
Appropriate to the tumor location colonic resection is performed with D2 lymph node dissection
Experimental: D3 lymph node dissection
Colonic resection with D3 lymph node dissection
Procedure: Colonic resection with D3 lymph node dissection
Appropriate to the tumor location colonic resection is performed with D3 lymph node dissection
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-editted 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03009227
|Contact: Aleksei Petrovfirstname.lastname@example.org|
|Contact: Aleksei Karachun, Ph.D.||+email@example.com|
|State Scientific Centre of Coloproctology||Recruiting|
|Moscow, Russian Federation, 123423|
|Contact: Sergei Achkasov firstname.lastname@example.org|
|Principal Investigator: Sergei Achkasov|
|Rostov Research Institute of Oncology||Recruiting|
|Rostov, Russian Federation, 344037|
|Contact: Yuriy Gevorkyan email@example.com|
|Principal Investigator: Yuriy Gevorkyan|
|Saint-Petersburg Clinical Research center of specialized kinds of medical care (Oncology)||Recruiting|
|Saint Petersburg, Russian Federation, 197758|
|Contact: Ilya Chernikovskiy firstname.lastname@example.org|
|Principal Investigator: Ilya Chernikovskiy|
|Scientific-Research institute of Oncology named after N.N. Petrov||Recruiting|
|Saint Petersburg, Russian Federation, 197758|
|Contact: Aleksei Petrov +79214117866 email@example.com|
|Principal Investigator: Aleksei Karachun|
|Sub-Investigator: Aleksei Petrov|
|Study Chair:||Aleksei Karachun, Ph.D.||N.N. Petrov Research Institute of Oncology, Surgical department of abdominal oncology, St. Petersburg, Russian Federation|