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

Recruiting now · Not applicable

Conditions studied: Locally Advanced Rectal Cancer (LARC)

In brief

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.

Key facts

Study ID

NCT06761287

Run by

Centre Hospitalier Universitaire Saint Pierre

People needed

20

Starts

2025-03-28

Expected to finish

2030-12-01

Last updated by the study team

2025-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years old
• Signed informed consent
• Patients diagnosed with locally advanced rectal cancer showing complete or near-complete clinical response after neoadjuvant therapy without evidence of invasive disease (>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.
• Patients diagnosed with locally advanced rectal cancer showing incomplete response with presence of superficial residual lesions, without invasive features on endoscopic evaluation, without evidence of invasive disease (>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.
• Without previous medical history of rectal cancer or rectal surgery

You may not qualify if…

• Previous medical history of rectal cancer
• Previous rectal surgery

Where it is running

• CHU Saint Pierre — Brussels, Belgium (enrolling)

Full record on ClinicalTrials.gov

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