Tests watchful waiting instead of surgery for rectal cancer after treatment
Studies watchful monitoring without surgery in adults with rectal cancer showing complete clinical response.
Key facts
- Who runs it
- Tampere University Hospital
- Where
- Helsinki, Jyväskylä, Kuopio, Oulu, Pori, Seinäjoki, Tampere, Turku, and Vaasa, FinlandSee the 9 sitesAlso in 1 other country, 4 sites
- Trial code
- Registry title
- Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 16 May 2024
- Expected to end
- 31 Dec 2032
- Type of study
- Interventional
- Treatments tested
- Nonoperative surveillance
- Record updated
- 30 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with rectal cancer (adenocarcinoma) whose tumour has fully gone after treatment before surgery. They would be watched instead of having an operation.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Primary rectal adenocarcinoma, confirmed by tissue examination, with a complete clinical response after treatment given before surgery (neoadjuvant therapy). No spread of the cancer to other organs.
- Earlier treatment
- Must have had neoadjuvant therapy (treatment given before surgery).
Main reasons for not taking part
- Signs that the cancer has spread to other organs (metastatic disease)
- No neoadjuvant therapy given
- Cannot understand the information about harms and benefits
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- Histopathological verification of primary rectal adenocarcinoma
- Complete clinical response at response assessment after neoadjuvant therapy
- Informed consent to organ preservation study
Who cannot take part
- No neoadjuvant therapy
- Evidence of metastatic disease (fulfilling M-class criteria of TNM)
- Inability to understand the information related to harms and benefits
Where in Finland
Also in 1 other country, 4 sites
- Helsinki University Central HospitalHelsinki, FinlandContact: Anna H Lepistö, MD, PhDTaking people
- Jyväskylä Central HospitalJyväskylä, FinlandContact: Kyösti Tahkola, MD, PhDTaking people
- Kuopio University HospitalKuopio, FinlandContact: Anne Fageström, MD, PhDTaking people
- Oulu University HospitalOulu, FinlandContact: Karoliina Paarmio, MD, PhDTaking people
- Satakunta Central HospitalPori, FinlandContact: Jyrki Haikonen, MD, PhDTaking people
- Seinäjoki Central HospitalSeinäjoki, FinlandContact: Ismo Laitinen, MD, PhDTaking people
- Tampere University HospitalTampere, FinlandContact: Toni T Seppälä, MD, PhDTaking people
- Turku University HospitalTurku, FinlandContact: Pirita Varpe, MD, PhDTaking people
- Vaasa Central HospitalVaasa, FinlandContact: Jan Andersen, MD, PhDTaking people
About the trial
What the trial wants to find out
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
Read full original descriptionShow less
* 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
The group in the trial
- Nonoperative managementTreatment being tested
The patients presenting with complete clinical response undergo nonoperative management (i.e. watch \& wait) as surveillance for local regrowth or distant spread.
Treatment: Nonoperative surveillance
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Nordic ORgan Preservation Pilot Approach - A Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer (NORPPA-1)
- Plain-language title
- Tests watchful waiting instead of surgery for rectal cancer after treatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 30 September 2026