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NCT Number: NCT06709144

Borderline of CME/D3 Dissection for Local Advanced Right-sided Colon Cancer

The study was conducted on patients with advanced right-sided colon cancer, and the clinical pathological and prognostic data of the patients were compared between the two groups of patients who were randomly divided into those undergoing SMV and SMA left resection, with the aim of resolving the controversy over the left resection boundary of CME/D3 lymph node dissection through this study, and to clarify whether SMA left resection is superior to SMV left resection.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhejiang cancer hospital

Hangzhou, Zhejiang, 310022, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • right side colon cancer(The primary lesion is located in the ileocecal region, ascending colon, hepatic flexure of colon, or proximal transverse colon)
  • T3-4 and/or N1-2M0
  • Colonoscopy and pathological biopsy confirmed colon adenocarcinoma

Exclusion criteria

  • T1-2N0M0
  • Cannot undergo curative resection
  • Simultaneous multiple primary colorectal cancer or other diseases requiring segmental resection
  • Distant metastasis
  • Tumor invades surrounding organs, requiring joint organ resection
  • Emergency surgery is required for complications such as intestinal obstruction, perforation, and bleeding
  • Patients who have received neoadjuvant therapy before surgery
  • Pregnant or lactating women
  • Patients who are not suitable or unable to tolerate surgery

Treatment and study plan

SMA lymph node dissection

Procedure

The lymph node dissection boundary is on the left side of the superior mesenteric artery (SMA)

SMV lymph node dissection

Procedure

The lymph node dissection boundary is on the left side of the superior mesenteric vein (SMV)

Primary outcomes

  1. 3 year DFS

    Time frame: 3 years

    3 year disease free survival

Secondary outcomes

  1. 5 year OS

    Time frame: 5 years

    5 year Overall survival

Sponsors and collaborators

Lead sponsor

Haixing Ju, MD

Other

Collaborators

  • Affiliated Hospital of Jiaxing University
  • Cancer Hospital of Guangxi Medical University
  • First Affiliated Hospital of Wenzhou Medical University
  • First Affiliated Hospital of Zhejiang University
  • Jiangsu Cancer Institute & Hospital
  • Jiangxi Provincial Cancer Hospital
  • Jinhua Central Hospital
  • Liaoning Cancer Hospital & Institute
  • Lishui Country People's Hospital
  • Ningbo Medical Center Lihuili Hospital
  • Ningbo No. 1 Hospital
  • Ningbo No.2 Hospital
  • Ruijin Hospital
  • Second Affiliated Hospital of Wenzhou Medical University
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Shanghai 10th People's Hospital
  • Shanghai Cancer Hospital, China
  • Shanxi Province Cancer Hospital
  • Shaoxing People's Hospital
  • Shaoxing Second Hospital
  • Sir Run Run Shaw Hospital
  • Sun Yat-Sen University Cancer Center
  • The Affiliated Tumor Hospital of Harbin Medical University
  • The Central Hospital of Lishui City
  • The First Affiliated Hospital of Shanxi Medical University
  • The First Affiliated Hospital of Soochow University
  • The First People's Hospital of Huzhou
  • The Second Affiliated Hospital of Harbin Medical University
  • The Third Affiliated Hospital of Wenzhou Medical University
  • Xiangshan No.1 People' s Hospital
  • Yuyao People's Hospital
  • Zhejiang Province People's Hospital
  • Zhejiang University

Registry information

Official study title

Borderline of CME/D3 Dissection for Local Advanced Right-sided Colon Cancer(BLARCC): a Prospective, Multicenter Randomized Control Clinical Trial

Acronym: BLARCC

Important dates

Study start
2024
Primary completion
2027
Study completion
2032
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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