Nonoperative management of rectal cancer after neoadjuvant therapy

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 clinical trial aims to evaluate the oncological outcomes of nonoperative management (NOM) for rectal cancer patients who achieve a complete clinical response following neoadjuvant therapy. It seeks to establish a unified NOM protocol for Finland and assess whether the outcomes align with international practices. The study is a prospective, non-randomized, single-arm trial that will monitor disease-free survival and other secondary endpoints over a period of two years and beyond. Participants will be closely monitored for local regrowth rates and quality of life after treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histopathological verification of primary rectal adenocarcinoma
* Complete clinical response at response assessment after neoadjuvant therapy
* Informed consent to organ preservation study

Exclusion Criteria:

* Evidence of metastatic disease (fulfilling M-class criteria of TNM)
* No neoadjuvant therapy
* Inability to understand the information related to harms and benefits

Where it's running

• East Tallinn Central Hospital
  Tallinn, Estonia Recruiting
• North Estonia Medical Centre
  Tallinn, Estonia Recruiting
• West Tallinn Central Hospital
  Tallinn, Estonia Recruiting
• Tartu University Hospital
  Tartu, Estonia Recruiting
• Helsinki University Central Hospital
  Helsinki, Finland Recruiting
• Jyväskylä Central Hospital
  Jyväskylä, Finland Recruiting

Study contacts

• Principal investigator: Toni T Seppälä, MD, PhD — Tampere University Hospital
• Study coordinator: Toni T Seppälä, MD, PhD
• Email: toni.seppala@tuni.fi
• Phone: +358444722846

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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.