Optimizing patient selection for surgery in advanced rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial evaluates the effectiveness of endoscopic resection following neoadjuvant therapy in patients with locally advanced rectal cancer. The study is divided into two phases: the first phase assesses the feasibility and safety of endoscopic resection of residual tissue, while the second phase aims to determine how this approach can guide patient selection for total mesorectal excision or serve as a definitive treatment for those with limited residual disease. The trial focuses on patients who have shown a complete or near-complete response to neoadjuvant therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Previous medical history of rectal cancer
* Previous rectal surgery

Where it's running

• CHU Saint Pierre
  Brussels, Belgium Recruiting

Study contacts

• Study coordinator: Mariana Figueiredo
• Email: mariana.figueiredo@stpierre-bru.be
• Phone: +32 23533332

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.