Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer
Recruiting · NCT06328361 · Interventional (participants receive a specific treatment) · Lead sponsor: Tampere University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Nonoperative surveillance
What this trial is about
The goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are * if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere * what is the organ preservation rate * what is the local regrowth rate
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
13 locations listed.
- Helsinki University Central Hospital - Helsinki, Finland
- Jyväskylä Central Hospital - Jyväskylä, Finland
- Kuopio University Hospital - Kuopio, Finland
- Oulu University Hospital - Oulu, Finland
- Satakunta Central Hospital - Pori, Finland
- Seinajoki Central Hospital - Seinäjoki, Finland
- East Tallinn Central Hospital - Tallinn, Estonia
- North Estonia Medical Centre - Tallinn, Estonia
- West Tallinn Central Hospital - Tallinn, Estonia
- Tampere University Hospital - Tampere, Finland
- Tartu University Hospital - Tartu, Estonia
- Turku University Hospital - Turku, Finland
- Vaasa Central Hospital - Vaasa, Finland