Nordic ORgan Preservation Pilot Approach - A Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer (NORPPA-1)
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histopathological verification of primary rectal adenocarcinoma
• Complete clinical response at response assessment after neoadjuvant therapy
• Informed consent to organ preservation study
Locations
Other Locations
Estonia
East Tallinn Central Hospital
RECRUITING
Tallinn
North Estonia Medical Centre
RECRUITING
Tallinn
West Tallinn Central Hospital
RECRUITING
Tallinn
Tartu University Hospital
RECRUITING
Tartu
Finland
Helsinki University Central Hospital
RECRUITING
Helsinki
Jyväskylä Central Hospital
RECRUITING
Jyväskylä
Kuopio University Hospital
RECRUITING
Kuopio
Oulu University Hospital
RECRUITING
Oulu
Satakunta Central Hospital
RECRUITING
Pori
Seinajoki Central Hospital
RECRUITING
Seinäjoki
Tampere University Hospital
RECRUITING
Tampere
Turku University Hospital
RECRUITING
Turku
Vaasa Central Hospital
NOT_YET_RECRUITING
Vaasa
Contact Information
Primary
Toni T Seppälä, MD, PhD
toni.seppala@tuni.fi
+358444722846
Time Frame
Start Date: 2024-05-16
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 200
Treatments
Experimental: Nonoperative management
The patients presenting with complete clinical response undergo nonoperative management (i.e. watch \& wait) as surveillance for local regrowth or distant spread.
Related Therapeutic Areas
Sponsors
Collaborators: North Estonia Medical Centre, East Tallinn Central Hospital, Oulu University Hospital, Tartu University Hospital, Jyväskylä Central Hospital, Helsinki University Central Hospital, Tampere University, Vaasa Central Hospital, Vaasa, Finland, West Tallinn Central Hospital, Turku University Hospital, Seinajoki Central Hospital, Satakunta Central Hospital, Kuopio University Hospital, North Karelia Central Hospital
Leads: Tampere University Hospital