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
Histopathological verification of primary rectal adenocarcinoma
Complete clinical response at response assessment after neoadjuvant therapy
Informed consent to organ preservation study
Evidence of metastatic disease (fulfilling M-class criteria of TNM)
No neoadjuvant therapy
Inability to understand the information related to harms and benefits
Single group
Nonoperative surveillance
Procedure/SurgeryClinical and imaging surveillance with digital rectal examination and/or endoscopy, rectal MRI and body CT
Disease-free survival
Survival from complete clinical response to locoregional failure or distant metastases
Overall survival
Survival from complete clinical response to death or censoring of observation
TME-free survival
Survival from complete clinical response to total mesorectal excision surgery
ctDNA-free survival
Survival from complete clinical response to positive ctDNA result
Post local regrowth disease-free survival
Survival from operated local regrowth to recurrence
Click on the lead sponsor to view all of their trials.
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
