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

February 8, 2020 updated by: XIAO Yi, MD, Peking Union Medical College Hospital

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1072

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Lai XU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: D2 radical operation group
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.
Procedure: D2 radical operation
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.
Experimental: CME group
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.
Procedure: Complete mesocolic excision (CME)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 3 years
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 30 days
Complications occurring within 30 days after surgery
30 days
Postoperative mortality
Time Frame: 30 days
Death occurred within 30 days after surgery
30 days
3 years overall survival
Time Frame: 3 years
The proportion of patients who survived 3 years after surgery
3 years
Metastasis rate of central lymph node (3rd station)
Time Frame: 7 days
Metastasis rate of central lymph node (3rd station)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

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

Investigators

  • Principal Investigator: Yi XIAO, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2016

Primary Completion (Actual)

December 26, 2019

Study Completion (Anticipated)

December 26, 2022

Study Registration Dates

First Submitted

November 29, 2015

First Submitted That Met QC Criteria

November 29, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 8, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RELARC

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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