NCT02619942

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,072

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 9, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2022

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

4 years

First QC Date

November 29, 2015

Last Update Submit

February 8, 2020

Conditions

Colon Cancer

Keywords

Right colon cancer, Survival, Laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    The proportion of patients with no disease recurrence and metastasis after 3 years of surgery

    3 years

Secondary Outcomes (4)

  • Postoperative complications

    30 days

  • Postoperative mortality

    30 days

  • 3 years overall survival

    3 years

  • Metastasis rate of central lymph node (3rd station)

    7 days

Study Arms (2)

D2 radical operation group

ACTIVE COMPARATOR

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

CME group

EXPERIMENTAL

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)

Interventions

D2 radical operationPROCEDURE

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.

D2 radical operation group
Complete mesocolic excision (CME)PROCEDURE

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.

CME group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lai XU

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (5)

  • Li K, Li H, Wu A, Zang L, Zhang G, Xu L, Lu J, Xing J, Feng B, Sun Y, Du X, Chi P, Xu J, Wang Z, Zhang Y, Zhang Z, Zheng M, Su X, Xiao Y; RELARC Study Group. Long-Term Survival on Extent of Lymphadenectomy for Right-Sided Colon Cancer: Five-Year Follow-up Results of a Randomized Controlled Trial (RELARC Trial). Ann Surg. 2025 Sep 12. doi: 10.1097/SLA.0000000000006941. Online ahead of print.

    PMID: 40938728DERIVED

  • Lu J, Xing J, Zang L, Zhang C, Xu L, Zhang G, He Z, Sun Y, Feng Y, Du X, Hu S, Chi P, Huang Y, 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 Y, Zhang Z, Zheng M, Su X, Xiao Y; RELARC study group. Extent of Lymphadenectomy for Surgical Management of Right-Sided Colon Cancer: The Randomized Phase III RELARC Trial. J Clin Oncol. 2024 Nov 20;42(33):3957-3966. doi: 10.1200/JCO.24.00393. Epub 2024 Aug 27.

    PMID: 39190853DERIVED

  • Sun Z, Zhang G, Lu J, Wu B, Lin G, Xiao Y, Xu L. Risk Factors for Postoperative Complications of Laparoscopic Right Colectomy: A Post Hoc Analysis of the RELARC Trial. Dis Colon Rectum. 2024 Sep 1;67(9):1194-1200. doi: 10.1097/DCR.0000000000003331. Epub 2024 May 21.

    PMID: 38773832DERIVED

  • 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.

    PMID: 33587893DERIVED

  • 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.

    PMID: 27931247DERIVED

Related Links

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Yi XIAO, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2015

First Posted

December 2, 2015

Study Start

January 9, 2016

Primary Completion

December 26, 2019

Study Completion

December 26, 2022

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

CN(1)