D2 vs D3 Lymph Node Dissection for Left Colon Cancer: Multicenter Randomize Control Trial (DILEMMA)
Who is this study for? Adult patients with Colon Adenocarcinoma
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The efficiency of the D3 lymph node dissection is still controversial for left colon cancer patients. This study will try find difference in 5-year overall survival between D2 and D3 lymph node dissection. Investigation of the functional and short-term outcomes will clarify safety of the D3 lymph node dissection.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Agreement of the patient to participate in trial
• Colon cancer (only adenocarcinoma )
• The tumor located between the splenic flexure and rectosigmoid junction
• cT3-Т4а,b
• cN0-2
• cM0
• Tolerance of chemotherapy
• ASA 1-3
Locations
Other Locations
Russian Federation
Clinic of coloproctology and minimally invasive surgery
RECRUITING
Moscow
Contact Information
Primary
Vladimir Balaban, Ph.D
balaban@kkmx.ru
+79889478358
Backup
Inna Tulina, Ph.D
tulina@kkmx.ru
+79264086672
Time Frame
Start Date: 2020-03-31
Estimated Completion Date: 2033-12-31
Participants
Target number of participants: 1381
Treatments
Active_comparator: D2 lymph node dissection
For tumours in splenic flexure and proximal and mid part of descending colon lymph nodes 232 and 231 will be removed.~For tumours in distal part of descending colon and proximal sigmoid lymph nodes 231, 232 and partially 241, 242 (considering variation of the feeding artery) will be removed.~For tumours in the mid part of sigmoid colon lymph nodes 241, 242 will be removed.~For tumours in the rectosigmoid junction 251, 252 groups of the lymph node will be removed.
Experimental: D3 lymph node dissection
For tumours in splenic flexure and proximal and mid part of descending colon lymph nodes 232, 231 and 253 will be removed.~For tumours in distal part of descending colon and proximal sigmoid lymph nodes 231, 232 and 253 and partially 241, 242 (considering variation of the feeding artery) will be removed.~For tumours in the mid part of sigmoid colon lymph nodes 241, 242 and 253 will be removed.~For tumours in the rectosigmoid junction 251, 252 and 253 groups of the lymph node will be removed.
Related Therapeutic Areas
Sponsors
Collaborators: I.M. Sechenov First Moscow State Medical University, G.V. Bondar Republican Cancer Center
Leads: Russian Society of Colorectal Surgeons