Clinical trial NCT06709144: Borderline of CME/D3 Dissection for Local Advanced Right-sided Colon Cancer
Official title: Borderline of CME/D3 Dissection for Local Advanced Right-sided Colon Cancer(BLARCC): a Prospective, Multicenter Randomized Control Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Colon Cancer
Keywords: right side colon cancer
complete mesentery resection
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Jiangxi Provincial Cancer Hospital
name: Jiangsu Cancer Institute & Hospital
name: Liaoning Cancer Hospital & Institute
name: The First Affiliated Hospital of Soochow University
name: Shanxi Province Cancer Hospital
name: The First Affiliated Hospital of Shanxi Medical University
name: Shaoxing People's Hospital
name: Shaoxing Second Hospital
name: Ningbo No. 1 Hospital
name: Ningbo No.2 Hospital
name: Jinhua Central Hospital
name: Affiliated Hospital of Jiaxing University
name: The First People's Hospital of Huzhou
name: The Central Hospital of Lishui City
name: Lishui Country People's Hospital
name: Zhejiang University
name: Yuyao People's Hospital
name: Rui'an People's hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: Cancer Hospital of Guangxi Medical University
name: Ningbo Medical Center Lihuili Hospital
name: Ruijin Hospital
name: Second Affiliated Hospital of Wenzhou Medical University
name: First Affiliated Hospital of Zhejiang University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Shanghai Cancer Hospital, China
name: The Affiliated Tumor Hospital of Harbin Medical University
name: Shanghai 10th People's Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: Xiangshan No.1 People' s Hospital
name: Zhejiang Province People's Hospital
name: Sir Run Run Shaw Hospital
name: Sun Yat-sen University Cancer Hosptial
First posted: 2024-11-29
Enrollment: 896
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 3 year DFS
timeFrame: 3 years
Secondary outcomes:
measure: 5 year OS
timeFrame: 5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Haixing Ju
role: PRINCIPAL_INVESTIGATOR
References: