Borderline of CME/D3 Dissection for Local Advanced Right-sided Colon Cancer (BLARCC)
November 27, 2024 updated by: Haixing Ju, MD
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
896
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Zhejiang Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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).
|
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)
|
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
Time Frame: 3 years
|
3 year disease free survival
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
5 year OS
Time Frame: 5 years
|
5 year Overall survival
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Haixing Ju, Zhejiang Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.