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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colon Cancer
• Intervention / Treatment: Procedure: SMA lymph node dissection; Procedure: SMV lymph node dissection

• Study Type: Interventional
• Enrollment (Estimated): 896
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group SMA; The lymph node dissection boundary is on the left side of the superior mesenteric artery (SMA).	Procedure: SMA lymph node dissection; The lymph node dissection boundary is on the left side of the superior mesenteric artery (SMA)
Active Comparator: Group SMV; The lymph node dissection boundary is on the left side of the superior mesenteric vein (SMV)	Procedure: SMV lymph node dissection; The lymph node dissection boundary is on the left side of the superior mesenteric vein (SMV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 year DFS	3 year disease free survival	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5 year OS	5 year Overall survival	5 years

Collaborators and Investigators

• Sponsor: Haixing Ju, MD
• Collaborators: Shanxi Province Cancer Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; Shanghai 10th People's Hospital; Ningbo Medical Center Lihuili Hospital; First Affiliated Hospital of Zhejiang University; The First Affiliated Hospital of Soochow University; Jiangxi Provincial Cancer Hospital; Jiangsu Cancer Institute & Hospital; Second Affiliated Hospital of Wenzhou Medical University; Shanghai Cancer Hospital, China; The First People's Hospital of Huzhou; The Central Hospital of Lishui City; First Affiliated Hospital of Wenzhou Medical University; Shaoxing People's Hospital; The Second Affiliated Hospital of Harbin Medical University; The First Affiliated Hospital of Shanxi Medical University; Shaoxing Second Hospital; Xiangshan No.1 People' s Hospital; Ningbo No. 1 Hospital; Jinhua Central Hospital; Ningbo No.2 Hospital; Cancer Hospital of Guangxi Medical University; Lishui Country People's Hospital; The Affiliated Tumor Hospital of Harbin Medical University; Zhejiang Province People's Hospital; Liaoning Cancer Hospital & Institute; Shengzhou People's Hospital; Sir Run Run Shaw Hospital, Zhejiang University; Sun Yat-sen University Cancer Hosptial; Affiliated Hospital of Jiaxing University; Ruijin Hospital Affiliated to Shanghai Jiao Tong University; Yuyao People's Hospital; Rui'an People's hospital
• Investigators: Principal Investigator: Haixing Ju, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2032

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: right side colon cancer; complete mesentery resection
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms
• Other Study ID Numbers: IRB-2024-935（IIT）; 2024IITZA001 (Other Identifier: Zhejiang cancer hospital)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No