Nonoperative management of rectal cancer after neoadjuvant therapy
Nordic ORgan Preservation Pilot Approach - A Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer (NORPPA-1)
This study is testing if people with rectal cancer who have a complete response to initial treatment can safely avoid surgery and still do well in terms of their health and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 13 sites (Tallinn and 12 other locations) |
| Trial ID | NCT06328361 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with histopathologically confirmed primary rectal adenocarcinoma who have achieved a complete clinical response after neoadjuvant therapy.
Not a fit: Patients with evidence of metastatic disease or those who have not undergone neoadjuvant therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for rectal cancer patients, potentially preserving the rectum and improving quality of life.
How similar studies have performed: Other studies have shown success with nonoperative management approaches for rectal cancer, indicating that this methodology is gaining traction internationally.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tallinn and 12 other locations
- 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)
- Kuopio University Hospital — Kuopio, Finland (Recruiting)
- Oulu University Hospital — Oulu, Finland (Recruiting)
- Satakunta Central Hospital — Pori, Finland (Recruiting)
- Seinajoki Central Hospital — Seinäjoki, Finland (Recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
- Turku University Hospital — Turku, Finland (Recruiting)
- Vaasa Central Hospital — Vaasa, Finland (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.