Organ preservation approach for locally 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

The PRONAR trial evaluates the feasibility and safety of an organ preservation strategy for patients with locally advanced rectal cancer who show a complete or nearly complete response to neoadjuvant treatment. Patients will undergo MRI and endoscopy to assess their response, with those meeting criteria offered a 'watch and wait' strategy or transanal endoscopic microsurgery. The study aims to analyze survival rates, local and distant relapse, and quality of life outcomes. A total of 30 patients will be recruited over a period of time to assess these outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with confirmed histopathological diagnosis of rectal adenocarcinoma.
* Patients treated with neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy associated or not with induction chemotherapy.
* Patients with evidence of complete or near complete response criteria after completion of neoadjuvant treatment (approximately 8 weeks later). Response criteria should be based on digital rectal examination, flexible rectoscopy and MRI.

Exclusion Criteria:

* Evidence of distant metastases.

Where it's running

• Hospital General Universitario de Elche
  Elche, Alicante, Spain Recruiting

Study contacts

• Principal investigator: Javier Gallego, PhD — Hospital General Universitario de Elche
• Study coordinator: Javier Gallego, PhD
• Email: j.gallegoplazas@gmail.com
• Phone: +34966616250

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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.