About this trial
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
Eligibility criteria
Qualifiers
Histopathological verification of primary rectal adenocarcinoma
Complete clinical response at response assessment after neoadjuvant therapy
Informed consent to organ preservation study
Disqualifiers
Evidence of metastatic disease (fulfilling M-class criteria of TNM)
No neoadjuvant therapy
Inability to understand the information related to harms and benefits
Trial design
Treatments tested in this trial
- Nonoperative surveillance
Treatment groups
Sponsors and collaborators
Tampere University Hospital
Lead sponsor
Tampere University
Collaborator
Helsinki University Central Hospital
Collaborator
Turku University Hospital
Collaborator
Kuopio University Hospital
Collaborator
Oulu University Hospital
Collaborator
Jyväskylä Central Hospital
Collaborator
Seinajoki Central Hospital
Collaborator
Satakunta Central Hospital
Collaborator
North Karelia Central Hospital
Collaborator
Tartu University Hospital
Collaborator
East Tallinn Central Hospital
Collaborator
West Tallinn Central Hospital
Collaborator
North Estonia Medical Centre
Collaborator
Vaasa Central Hospital, Vaasa, Finland
Collaborator