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Reducing the Resection Range After Neoadjuvant Therapy for Locally Advanced Upper Rectal and Rectosigmoid Junction Cancers

NCT07038122 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 874

Last updated 2025-12-18

No results posted yet for this study

Summary

The goal of this clinical trial is to learn evaluate the safety and efficacy of reduced surgical resection margins in patients with local advanced upper rectal or rectosigmoid junction tumors who met the ycT≤3N0M0 regression following neoadjuvant therapy. The main questions it aims to answer are:

Does reduced surgical resection margins (3 cm of distal margin and 5 cm of proximal margin) meet the radical resection criteria, including the rate of negative resection margin, the number of lymph node harvested? How is the surgical safety of reduced surgical resection, including the surgical duration , bleeding, recovery time and postoperative complications? Is reduced surgical margins resection (3 cm of distal margin and 5 cm of proximal margin) inferior to conventional surgical margins resection (5 cm of distal margin and 10 cm of proximal margin) in terms of oncology safety?

Conditions

  • Locally Advanced Rectal Carcinoma

Interventions

PROCEDURE

Laparoscopic resection

Laparoscopic resection of bowel and corresponding mesentery.

OTHER

Neoadjuvant Therapy

Neoadjuvant Therapy aims to downstage the tumor including different chemotherapy, targeted therapy and immunotherapy.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jun Huang, PhD. · The Sixth Affiliated Hospital, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-06-20
Completion
2028-06-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07038122 on ClinicalTrials.gov