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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
896

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
3 year DFS
Time Frame: 3 years
3 year disease free survival
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haixing Ju, MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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