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Investigate the Radical Extent of Lymphadenectomy of LAparoscopic Right Colectomy for Colon Cancer(RELARC). (RELARC)

Primary Purpose

Colon Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
D2 radical operation
Complete mesocolic excision (CME)
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Right colon cancer, Survival, Laparoscopic surgery

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients suitable for curative surgery 18-75years old
  2. ASA grade I-III
  3. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
  4. Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon;
  5. Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T2-T4N0 or TanyN+; there is no distant metastasis.
  6. Informed consent

Exclusion Criteria:

  1. Simultaneous or simultaneous multiple primary colorectal cancer;
  2. Preoperative imaging examination results show: (1) colon cancer of stage T1N0; (2) enlargement of lymph node at the root of mesocolon, in which case the D3 radical operation must be performed;
  3. Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection;
  4. History of any other malignant tumor in recent 5 years, except for cervical carcinoma in situ which has been cured, basal cell carcinoma or squamous cell carcinoma of skin;
  5. Patients need emergency operation;
  6. Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
  7. Informed consent refusal

Sites / Locations

  • Lai XU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

D2 radical operation group

CME group

Arm Description

In D2 radical operation group(D2), the mesocolon should be removed and the dissection involves the paracolon and intermediate lymph nodes, which along the feeding vessels.

In complete mesocolic excision group (CME), in addition to D2 dissection, the whole mesocolon, from ascending colon to right half transverse colon, as well as the central lymph nodesmshould be entirely removed.

Outcomes

Primary Outcome Measures

Disease-free survival
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery

Secondary Outcome Measures

Postoperative complications
Complications occurring within 30 days after surgery
Postoperative mortality
Death occurred within 30 days after surgery
3 years overall survival
The proportion of patients who survived 3 years after surgery
Metastasis rate of central lymph node (3rd station)
Metastasis rate of central lymph node (3rd station)

Full Information

First Posted
November 29, 2015
Last Updated
February 8, 2020
Sponsor
Peking Union Medical College Hospital
Collaborators
Chinese PLA General Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Peking University Cancer Hospital & Institute, Beijing Friendship Hospital, Xuanwu Hospital, Beijing, Ruijin Hospital, Shanghai Zhongshan Hospital, The First Hospital of Jilin University, Nanfang Hospital, Southern Medical University, Fujian Medical University Union Hospital, Peking Union Medical College, Peking University People's Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Harbin Medical University, RenJi Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02619942
Brief Title
Investigate the Radical Extent of Lymphadenectomy of LAparoscopic Right Colectomy for Colon Cancer(RELARC).
Acronym
RELARC
Official Title
A Multicenter, Prospective, Randomized Clinical Trial to Investigate the Radical Extent of Lymphadenectomy: D2 Dissection vs. Complete Mesocolic Excision, of LAparoscopic Right Colectomy for Right-sided Colon Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 9, 2016 (Actual)
Primary Completion Date
December 26, 2019 (Actual)
Study Completion Date
December 26, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Chinese PLA General Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Peking University Cancer Hospital & Institute, Beijing Friendship Hospital, Xuanwu Hospital, Beijing, Ruijin Hospital, Shanghai Zhongshan Hospital, The First Hospital of Jilin University, Nanfang Hospital, Southern Medical University, Fujian Medical University Union Hospital, Peking Union Medical College, Peking University People's Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Harbin Medical University, RenJi Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, West China Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve disease-free survival in patients with right colon cancer, compared with standard D2 radical operation.
Detailed Description
Our study design is a two-arm, parallel-group, single-blind randomized clinical trial. The enrolled colon cancer patients would be divided into the intervention group (CME group) and control group (D2 radical operation group). The postoperative adjuvant chemotherapy is determined by the pathological results. For patients of stage Ⅲ and patients of stage Ⅱ with unfavorable histologic features, six months of adjuvant chemotherapy of XELOX or fluorouracil-based regimen are recommended. The postoperative examination should be performed every four months in the first two years and every six months in the following three years, to exclude local recurrence and distant metastasis. Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Right colon cancer, Survival, Laparoscopic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1072 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
D2 radical operation group
Arm Type
Active Comparator
Arm Description
In D2 radical operation group(D2), the mesocolon should be removed and the dissection involves the paracolon and intermediate lymph nodes, which along the feeding vessels.
Arm Title
CME group
Arm Type
Experimental
Arm Description
In complete mesocolic excision group (CME), in addition to D2 dissection, the whole mesocolon, from ascending colon to right half transverse colon, as well as the central lymph nodesmshould be entirely removed.
Intervention Type
Procedure
Intervention Name(s)
D2 radical operation
Intervention Description
In D2 radical operation group(D2), the lymph node dissection is based on ligating the supplying vessels close to the right-side of superior mesenteric vein and clean up the surrounding lymph node and adipose tissue.
Intervention Type
Procedure
Intervention Name(s)
Complete mesocolic excision (CME)
Intervention Description
In complete mesocolic excision group (CME), the dissecting extent includes the lymphatic and fat tissues surrounding the root of ascending mesocolon, which situated on the surface of superior mesenteric vein, and the root of right half of transverse mesocolon, which situated on the surface of pancreas neck.
Primary Outcome Measure Information:
Title
Disease-free survival
Description
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Complications occurring within 30 days after surgery
Time Frame
30 days
Title
Postoperative mortality
Description
Death occurred within 30 days after surgery
Time Frame
30 days
Title
3 years overall survival
Description
The proportion of patients who survived 3 years after surgery
Time Frame
3 years
Title
Metastasis rate of central lymph node (3rd station)
Description
Metastasis rate of central lymph node (3rd station)
Time Frame
7 days

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: Patients suitable for curative surgery 18-75years old ASA grade I-III Qualitative diagnosis: a pathological diagnosis of adenocarcinoma; Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon; Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T2-T4N0 or TanyN+; there is no distant metastasis. Informed consent Exclusion Criteria: Simultaneous or simultaneous multiple primary colorectal cancer; Preoperative imaging examination results show: (1) colon cancer of stage T1N0; (2) enlargement of lymph node at the root of mesocolon, in which case the D3 radical operation must be performed; Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection; History of any other malignant tumor in recent 5 years, except for cervical carcinoma in situ which has been cured, basal cell carcinoma or squamous cell carcinoma of skin; Patients need emergency operation; Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc). Informed consent refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi XIAO, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lai XU
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33587893
Citation
Xu L, Su X, He Z, Zhang C, Lu J, Zhang G, Sun Y, Du X, Chi P, Wang Z, Zhong M, Wu A, Zhu A, Li F, Xu J, Kang L, Suo J, Deng H, Ye Y, Ding K, Xu T, Zhang Z, Zheng M, Xiao Y; RELARC Study Group. Short-term outcomes of complete mesocolic excision versus D2 dissection in patients undergoing laparoscopic colectomy for right colon cancer (RELARC): a randomised, controlled, phase 3, superiority trial. Lancet Oncol. 2021 Mar;22(3):391-401. doi: 10.1016/S1470-2045(20)30685-9. Epub 2021 Feb 12.
Results Reference
derived
PubMed Identifier
27931247
Citation
Lu JY, Xu L, Xue HD, Zhou WX, Xu T, Qiu HZ, Wu B, Lin GL, Xiao Y. The Radical Extent of lymphadenectomy - D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled trial. Trials. 2016 Dec 8;17(1):582. doi: 10.1186/s13063-016-1710-9.
Results Reference
derived
Links:
URL
http://www.trialsjournal.com/content/17/1/582
Description
The Radical Extent of lymphadenectomy D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled tria
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://www.trialsjournal.com/content/17/1/582

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Investigate the Radical Extent of Lymphadenectomy of LAparoscopic Right Colectomy for Colon Cancer(RELARC).

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