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D2 vs D3 Lymph Node Dissection for Left Colon Cancer (DILEMMA)

Primary Purpose

Colon Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Left colon resection
Sigmoid colon resection
Distal sigmoid colon resection or anterior resection
Sponsored by
Russian Society of Colorectal Surgeons
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring D2, D3, lymph node dissection, complete mesocolic excision, left colon cancer, CME

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Agreement of the patient to participate in trial
  2. Colon cancer (only adenocarcinoma )
  3. The tumor located between the splenic flexure and rectosigmoid junction
  4. cT3-Т4а,b
  5. cN0-2
  6. cM0
  7. Tolerance of chemotherapy
  8. ASA 1-3

Exclusion Criteria:

  1. сТis - Т2, сТ4b (tail of the pancreas, stomach, small bowel, ureter, urinary bladder)
  2. Preoperative complications of the tumor (perforation and full bowel 3. obstruction)
  3. Previous radiotherapy or chemotherapy
  4. Synchronous or metachronous tumors
  5. Women during Pregnancy or breast feeding period

Sites / Locations

  • Clinic of coloproctology and minimally invasive surgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

D2 lymph node dissection

D3 lymph node dissection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

5-year overall survival
Probability to be alive measured in %, where 100% means that patients have a 100% probability to be alive and 0% means that patients have 0% probability to be alive

Secondary Outcome Measures

5-year disease free survival
Probability to be alive with no signs of local or distant recurrence measured in %, where 100% means that patients have a 100% probability to be alive with no signs of local or distant recurrence and 0% means that patients have 0% probability to be alive with no signs of local or distant recurrence
Postoperative sexual dysfunction
The rate of ejaculation problems in sexually active men and the rate of decreased vaginal lubricant production in sexually active women, measured in % from the total number of male/female patients
Apical lymph node involvement rate
The rate of lymph nodes 253 with metastatic cells among all lymph nodes 253, measured in %
Intraoperative complications rate
The rate of any complications within the course of surgery
Early postoperative complications rate
The rate of surgical and infectious complications
Mortality
The rate of death from all causes
Late postoperative complications rate
The rate of surgical and infectious complications

Full Information

First Posted
April 1, 2020
Last Updated
November 4, 2022
Sponsor
Russian Society of Colorectal Surgeons
Collaborators
I.M. Sechenov First Moscow State Medical University, G.V. Bondar Republican Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04364373
Brief Title
D2 vs D3 Lymph Node Dissection for Left Colon Cancer
Acronym
DILEMMA
Official Title
D2 vs D3 Lymph Node Dissection for Left Colon Cancer: Multicenter Randomize Control Trial (DILEMMA)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Russian Society of Colorectal Surgeons
Collaborators
I.M. Sechenov First Moscow State Medical University, G.V. Bondar Republican Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Discussion about optimal type of lymph node dissection in colorectal cancer continues during last 15 years, when in Europe was presented concept of complete mesocolic excision. However, this concepts is very close to Japanese D3 lymph node dissection and in the first view it seems the same but principal differences were found. Japanese concept is partial resection of the bowel according feeding artery (short bowel specimen, long lymphovascular pedicle), opposite European concept is wide resection of the bowel like hemicolectomy or extended hemicolectomy, sigmoidectomy. In complete mesocolic excision anatomical landmarks are still unclear but in Japanese guidelines it has anatomical margins which can standardize this procedure. Also nerve sparing technique around root of inferior mesenteric artery was described. One more difference is in histological examination of the specimen. European concept is to pay more attention to the quality of complete mesocolic excision and less - to the number of investigated lymph nodes. In Japan lymph node extraction is performed by surgical team from the fresh specimen and send to pathologist separately (each group of lymph nodes). Considering the absence of randomized control trials for patients with left colon cancer DILEMMA trial was started using Japanese approach

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
D2, D3, lymph node dissection, complete mesocolic excision, left colon cancer, CME

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1381 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
D2 lymph node dissection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
D3 lymph node dissection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Left colon resection
Intervention Description
This procedure is performed for tumours in splenic flexure and proximal and descending colon. Left colic artery is divided at its origin. Sigmoid arteries and superior rectal arteries are preserved. Inferior mesenteric vein is divided at the lower border of the pancreas. The colon is divided about 10 cm proximal and distal to the tumour. Mesocolic fascia is preserved and the length of the "vessel trunk" of the mesocolon corresponds to the level of lymph node dissection. After removal of the resected colonic segment a handsewn or stapler end-to-end or side-to-side colonic anastomosis is performed.
Intervention Type
Procedure
Intervention Name(s)
Sigmoid colon resection
Intervention Description
This procedure is performed for tumours in sigmoid colon. Corresponding sigmoid arteries are divided at their origin. Left colic artery and superior rectal artery are preserved. Inferior mesenteric vein is divide close to the left colic artery. Proximal and distal margin compose 10 cm from the tumour. Mesocolic fascia is preserved and the length of the "vessel trunk" of the mesocolon corresponds to the level of lymph nodes dissection. After removal of the resected colonic segment a handsewn end-to-end or side-to-side or stapler colonic anastomosis is performed.
Intervention Type
Procedure
Intervention Name(s)
Distal sigmoid colon resection or anterior resection
Intervention Description
This procedure is performed for tumours in distal sigmoid colon or rectosigmoid junction. Superior rectal artery is divided below the origin of left colic artery. Left colic artery is preserved. Inferior mesenteric vein is divide close to the left colic artery. The colon is divided about 10 cm proximal and 5 cm distal to the tumour. Mesocolic fascia is preserved and the length of the "vessel trunk" of the mesocolon corresponds to the level of lymph node dissection. After removal of the resected colonic segment handsewn or stapler colo-rectal anastomosis is performed.
Primary Outcome Measure Information:
Title
5-year overall survival
Description
Probability to be alive measured in %, where 100% means that patients have a 100% probability to be alive and 0% means that patients have 0% probability to be alive
Time Frame
Up to 5 years post-operatively
Secondary Outcome Measure Information:
Title
5-year disease free survival
Description
Probability to be alive with no signs of local or distant recurrence measured in %, where 100% means that patients have a 100% probability to be alive with no signs of local or distant recurrence and 0% means that patients have 0% probability to be alive with no signs of local or distant recurrence
Time Frame
Up to 5 years post-operatively
Title
Postoperative sexual dysfunction
Description
The rate of ejaculation problems in sexually active men and the rate of decreased vaginal lubricant production in sexually active women, measured in % from the total number of male/female patients
Time Frame
Up to 1 year post-operatively
Title
Apical lymph node involvement rate
Description
The rate of lymph nodes 253 with metastatic cells among all lymph nodes 253, measured in %
Time Frame
1 month after surgery
Title
Intraoperative complications rate
Description
The rate of any complications within the course of surgery
Time Frame
Day 0
Title
Early postoperative complications rate
Description
The rate of surgical and infectious complications
Time Frame
1-30 days after surgery
Title
Mortality
Description
The rate of death from all causes
Time Frame
0-30 days after surgery
Title
Late postoperative complications rate
Description
The rate of surgical and infectious complications
Time Frame
30-180 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: сТis - Т2, сТ4b (tail of the pancreas, stomach, small bowel, ureter, urinary bladder) Preoperative complications of the tumor (perforation and full bowel 3. obstruction) Previous radiotherapy or chemotherapy Synchronous or metachronous tumors Women during Pregnancy or breast feeding period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir Balaban, Ph.D
Phone
+79889478358
Email
balaban@kkmx.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Inna Tulina, Ph.D
Phone
+79264086672
Email
tulina@kkmx.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Tsarkov, Ph.D
Organizational Affiliation
I.M. Sechenov First Moscow State Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Clinic of coloproctology and minimally invasive surgery
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Balaban, Ph.D
Phone
+79889478358
Email
balaban@kkmx.ru
First Name & Middle Initial & Last Name & Degree
Inna Tulina, Ph.D
Phone
+79264086672
Email
tulina@kkmx.ru
First Name & Middle Initial & Last Name & Degree
Mihail Mutyk

12. IPD Sharing Statement

Plan to Share IPD
No

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D2 vs D3 Lymph Node Dissection for Left Colon Cancer

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