NCT06709144

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
896

participants targeted

Target at P75+ for phase_3

Timeline
74mo left

Started Jul 2024

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Jul 2024Jun 2032

Study Start

First participant enrolled

July 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2032

Last Updated

November 29, 2024

Status Verified

August 1, 2024

Enrollment Period

3 years

First QC Date

November 18, 2024

Last Update Submit

November 27, 2024

Conditions

Colon Cancer

Keywords

right side colon cancercomplete mesentery resection

Outcome Measures

Primary Outcomes (1)

  • 3 year DFS

    3 year disease free survival

    3 years

Secondary Outcomes (1)

  • 5 year OS

    5 years

Study Arms (2)

Group SMA

EXPERIMENTAL

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

Procedure: SMA lymph node dissection

Group SMV

ACTIVE COMPARATOR

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

Procedure: SMV lymph node dissection

Interventions

SMA lymph node dissectionPROCEDURE

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

Group SMA
SMV lymph node dissectionPROCEDURE

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

Group SMV

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang cancer hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Haixing Ju

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 29, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2032

Last Updated

November 29, 2024

Record last verified: 2024-08

Locations

CN(1)