Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06761287

Optimizing Patient Selection for Surgery Using Pathologic Analysis Following Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Led by Centre Hospitalier Universitaire Saint Pierre · Updated on 2025-05-30

20

Participants Needed

1

Research Sites

296 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This interventional, non-randomized, prospective trial aims to evaluate the role of endoscopic resection following neoadjuvant treatment in patients with locally advanced rectal cancer. Phase I focuses on assessing the feasibility, safety and efficacy of endoscopic resection of residual scar or superficial residual neoplastic tissue following neoadjuvant treatment. Phase II explores the potential of this approach to guide patient selection for total mesorectal excision and to serve as a definitive treatment option for those with limited residual disease.

CONDITIONS

Official Title

Optimizing Patient Selection for Surgery Using Pathologic Analysis Following Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years old
  • Signed informed consent
  • Diagnosed with locally advanced rectal cancer showing complete or near-complete clinical response after neoadjuvant therapy without invasive disease (greater than T2) or locoregional invasion on MRI and without metastatic disease on CT scan
  • Diagnosed with locally advanced rectal cancer showing incomplete response with superficial residual lesions, no invasive features on endoscopic evaluation, no invasive disease (greater than T2) or locoregional invasion on MRI and no metastatic disease on CT scan
  • No previous medical history of rectal cancer or rectal surgery
Not Eligible

You will not qualify if you...

  • Previous medical history of rectal cancer
  • Previous rectal surgery

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Saint Pierre

Brussels, Belgium, 1000

Actively Recruiting

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Research Team

M

Mariana Figueiredo

CONTACT

A

Amélie Deleporte

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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