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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02619942
Recruitment Status : Active, not recruiting
First Posted : December 2, 2015
Last Update Posted : February 11, 2020
Sponsor:
Collaborators:
Chinese PLA General Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Beijing Cancer Hospital
Beijing Friendship Hospital
Xuanwu Hospital, Beijing
Ruijin Hospital
Shanghai Zhongshan Hospital
First Hospital of Jilin University
Nanfang Hospital of 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
Information provided by (Responsible Party):
XIAO Yi, MD, Peking Union Medical College Hospital

Tracking Information
First Submitted Date  ICMJE November 29, 2015
First Posted Date  ICMJE December 2, 2015
Last Update Posted Date February 11, 2020
Actual Study Start Date  ICMJE January 9, 2016
Actual Primary Completion Date December 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
Disease-free survival [ Time Frame: 3 years ]
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2015)
Disease-free survival [ Time Frame: 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Postoperative complications [ Time Frame: 30 days ]
    Complications occurring within 30 days after surgery
  • Postoperative mortality [ Time Frame: 30 days ]
    Death occurred within 30 days after surgery
  • 3 years overall survival [ Time Frame: 3 years ]
    The proportion of patients who survived 3 years after surgery
  • Metastasis rate of central lymph node (3rd station) [ Time Frame: 7 days ]
    Metastasis rate of central lymph node (3rd station)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2015)
  • Postoperative complications [ Time Frame: 30 days ]
  • Postoperative mortality [ Time Frame: 30 days ]
  • 3 years overall survival [ Time Frame: 3 years ]
  • Metastasis rate of central lymph node (3rd station) [ Time Frame: 7 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigate the Radical Extent of Lymphadenectomy of LAparoscopic Right Colectomy for Colon Cancer(RELARC).
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: D2 radical operation
  • 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.
    Intervention: Procedure: Complete mesocolic excision (CME)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2015)
1072
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 26, 2022
Actual Primary Completion Date December 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02619942
Other Study ID Numbers  ICMJE RELARC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party XIAO Yi, MD, Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE
  • Chinese PLA General Hospital
  • Sixth Affiliated Hospital, Sun Yat-sen University
  • Beijing Cancer Hospital
  • Beijing Friendship Hospital
  • Xuanwu Hospital, Beijing
  • Ruijin Hospital
  • Shanghai Zhongshan Hospital
  • First Hospital of Jilin University
  • Nanfang Hospital of 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
Investigators  ICMJE
Principal Investigator: Yi XIAO, MD Peking Union Medical College Hospital
PRS Account Peking Union Medical College Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP