Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTampere University Hospital

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

200 Participants
are divided into 1 treatment group

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