Rectal CancerNORPPA-1NCT06328361
Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer
A study testing Nonoperative surveillance in people with Rectal Cancer and Rectal Adenocarcinoma, run by Tampere University Hospital at 13 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Rectal Adenocarcinoma
- What is being tested?
- Nonoperative surveillance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 16 May 2024to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathological verification of primary rectal adenocarcinoma
- Complete clinical response at response assessment after neoadjuvant therapy
- Informed consent to organ preservation study
Who cannot join
- Evidence of metastatic disease (fulfilling M-class criteria of TNM)
- No neoadjuvant therapy
- Inability to understand the information related to harms and benefits
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
Finland9 sites, 9 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki, 00290
Anna H Lepistö, MD, PhD, anna.lepisto@hus.fi
- Recruiting
Jyväskylä Central Hospital
Jyväskylä
Kyösti Tahkola, MD, PhD, kyosti.tahkola@hyvaks.fi
- Recruiting
Kuopio University Hospital
Kuopio
Anne Fageström, MD, PhD, anne.fagerstrom@pshyvinvointialue.fi
- Recruiting
Oulu University Hospital
Oulu
Karoliina Paarmio, MD, PhD, karoliina.paarnio@pohde.fi
- Recruiting
Satakunta Central Hospital
Pori
Jyrki Haikonen, MD, PhD, jyrki.haikonen@sata.fi
- Recruiting
Seinajoki Central Hospital
Seinäjoki
Ismo Laitinen, MD, PhD, ismo.laitinen@hyvaep.fi
- Recruiting
Tampere University Hospital
Tampere, 33400
Toni T Seppälä, MD, PhD, +358444722846, toni.seppala@tuni.fi
- Recruiting
Turku University Hospital
Turku
Pirita Varpe, MD, PhD, Pirita.Varpe@tyks.fi
- Recruiting
Vaasa Central Hospital
Vaasa, 65100
Jan Andersen, MD, PhD, 358 6 2181111, jan.andersen@ovph.fi
Jan Andersen, MD, PhD
Estonia4 sites, 4 recruiting
- Recruiting
East Tallinn Central Hospital
Tallinn
Mihkel Mettis, MD, PhD, mihkel.mettis@itk.ee
- Recruiting
North Estonia Medical Centre
Tallinn
Indrek Seire, MD, PhD, indrek.seire@ut.ee
- Recruiting
West Tallinn Central Hospital
Tallinn
Kaur Liivak, MD, PhD, kaur.liivak@keskhaigla.ee
- Recruiting
Tartu University Hospital
Tartu
Jaan Soplepman, MD, PhD, jaan.soplepmann@kliinikum.ee
About this study
Official title: Nordic ORgan Preservation Pilot Approach - A Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer (NORPPA-1)
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
Read the detailed description
Background: Non-operative management (NOM) for rectal cancer is an accepted treatment option that has not been commonly utilized in Finland but has been widely adopted in major cancer centers worldwide. NOM can be considered if the rectal tumor disappears with neoadjuvant treatment, resulting in a complete clinical response.
Objective: The aim of the study is to establish a unified NOM protocol for national use and determine whether the outcomes of Finnish and Estonian treatment practices align with international experiences.
Design: The study is a prospective, non-randomized, single-arm, international multicenter trial examining the oncological and quality-of-life consequences of NOM.
Primary Endpoint: The primary endpoint is disease-free survival 2 years after the initiation of NOM.
Secondary Endpoints: These include overall survival, disease-specific survival, survival free from total mesorectal excision (TME) surgery, survival free from circulating tumor DNA (ctDNA) detection after complete clinical response, recurrence-free survival, incidence of local recurrence and metastases, salvage TME success rate, quality of life at 1 year post-NOM, and treatment-related morbidity up to 5 years.
Inclusion Criteria: Patients must have histopathologically confirmed primary rectal adenocarcinoma before neoadjuvant treatment, achieve clinical complete response (cCR) after neoadjuvant therapy, and express willingness to undergo rectum-preserving treatment after considering the risk of recurrence.
Exclusion Criteria: Patients with evidence of metastasis at diagnosis, aged under 18, those not receiving neoadjuvant treatment, or those unable to provide informed consent are excluded.
Diagnosis and Treatment: Pretreatment of patients follows standard practice. Upon meeting inclusion criteria with confirmed cCR, patients undergo protocolized monitoring with clinical examination, laboratory tests, and imaging.
Randomization: No randomization is performed.
Follow-up: Patients are monitored every 3 months for the first 2 years, then every 6 months for 3 years. Monitoring replaces surgical intervention unless cancer recurs. Follow-up is part of standard care, with costs covered by the healthcare system.
Safety: Incidence of local recurrence and success of resection post-recurrence are monitored closely. If over 30% local recurrence occurs post-cCR, it may necessitate study termination at the center.
Data Collection: Clinical data are entered into electronic case report forms (eCRFs) based on primary healthcare documentation and stored pseudonymized on the primary research center's server. Molecular and pseudonymized clinical data are collected securely for analysis.
Sample Size Calculation and Statistical Analysis: A sample of 200 patients is estimated to provide sufficient data for the primary and key secondary endpoints and to meet other study objectives accurately.
Data Handling: Data handling adheres to privacy legislation, with information stored pseudonymously.
- Conditions
- Rectal Cancer, Rectal Adenocarcinoma
- Being tested
- Nonoperative surveillance
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonoperative surveillanceProcedure or surgery
Also called Watch and Wait, Organ preservation
Clinical and imaging surveillance with digital rectal examination and/or endoscopy, rectal MRI and body CT
| Study group | Role | What they receive |
|---|---|---|
| Nonoperative management | Experimental | The patients presenting with complete clinical response undergo nonoperative management (i.e. watch \& wait) as surveillance for local regrowth or distant spread. Receives: Procedure: Nonoperative surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Survival from complete clinical response to locoregional failure or distant metastases
Measured: 2 years
Secondary outcomes (12)
Overall survival
Survival from complete clinical response to death or censoring of observation
Measured: 5 years
TME-free survival
Survival from complete clinical response to total mesorectal excision surgery
Measured: 5 years
ctDNA-free survival
Survival from complete clinical response to positive ctDNA result
Measured: 5 years
Post local regrowth disease-free survival
Survival from operated local regrowth to recurrence
Measured: 5 years
Post local regrowth overall survival
Survival from operated local regrowth to death or censoring of observation
Measured: 5 years
Local regrowth-free survival
Survival from complete clinical response to local regrowth
Measured: 5 years
Local recurrence-free survival
Survival from complete clinical response to local recurrence after local regrowth
Measured: 5 years
Distant metastases-free survival
Survival from complete clinical response to distant metastases
Measured: 5 years
Disease-free survival
Survival from complete clinical response to locoregional failure or distant metastases
Measured: 5 years
Salvage rate after local regrowth
Rate of successful TME surgery, local excision or metastasectomy after local regrowth
Measured: 5 years
Quality of life score
Baseline and change in quality of life after complete clinical response
Measured: 5 years
Complication rates
Clavien-Dindo complications after NOM and after local regrowth and after recurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start16 May 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, Helsinki University Central Hospital, Turku University Hospital, Kuopio University Hospital, Oulu University Hospital, Jyväskylä Central Hospital, Seinajoki Central Hospital, Satakunta Central Hospital, North Karelia Central Hospital, Tartu University Hospital, East Tallinn Central Hospital, West Tallinn Central Hospital, North Estonia Medical Centre, Vaasa Central Hospital, Vaasa, Finland
- Responsible party
- Sponsor
- Investigators
- Toni T Seppälä, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328361
- Sponsor's protocol ID
- R24008
- Acronym
- NORPPA-1
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The European Data Protection Regulation (GDPR) does not allow sharing other than anonymised patient level data.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nordic ORgan Preservation Pilot Approach - A Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer (NORPPA-1)
- ClinicalTrials.gov ID
- NCT06328361
- Acronym / sponsor ID
- NORPPA-1 / R24008
- Conditions
- Rectal Cancer, Rectal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, Helsinki University Central Hospital, Turku University Hospital, Kuopio University Hospital, Oulu University Hospital, Jyväskylä Central Hospital, Seinajoki Central Hospital, Satakunta Central Hospital, North Karelia Central Hospital, Tartu University Hospital, East Tallinn Central Hospital, West Tallinn Central Hospital, North Estonia Medical Centre, Vaasa Central Hospital, Vaasa, Finland
- Study start
- 16 May 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Background: Non-operative management (NOM) for rectal cancer is an accepted treatment option that has not been commonly utilized in Finland but has been widely adopted in major cancer centers worldwide. NOM can be considered if the rectal tumor disappears with neoadjuvant treatment, resulting in a complete clinical response.
Objective: The aim of the study is to establish a unified NOM protocol for national use and determine whether the outcomes of Finnish and Estonian treatment practices align with international experiences.
Design: The study is a prospective, non-randomized, single-arm, international multicenter trial examining the oncological and quality-of-life consequences of NOM.
Primary Endpoint: The primary endpoint is disease-free survival 2 years after the initiation of NOM.
Secondary Endpoints: These include overall survival, disease-specific survival, survival free from total mesorectal excision (TME) surgery, survival free from circulating tumor DNA (ctDNA) detection after complete clinical response, recurrence-free survival, incidence of local recurrence and metastases, salvage TME success rate, quality of life at 1 year post-NOM, and treatment-related morbidity up to 5 years.
Inclusion Criteria: Patients must have histopathologically confirmed primary rectal adenocarcinoma before neoadjuvant treatment, achieve clinical complete response (cCR) after neoadjuvant therapy, and express willingness to undergo rectum-preserving treatment after considering the risk of recurrence.
Exclusion Criteria: Patients with evidence of metastasis at diagnosis, aged under 18, those not receiving neoadjuvant treatment, or those unable to provide informed consent are excluded.
Diagnosis and Treatment: Pretreatment of patients follows standard practice. Upon meeting inclusion criteria with confirmed cCR, patients undergo protocolized monitoring with clinical examination, laboratory tests, and imaging.
Randomization: No randomization is performed.
Follow-up: Patients are monitored every 3 months for the first 2 years, then every 6 months for 3 years. Monitoring replaces surgical intervention unless cancer recurs. Follow-up is part of standard care, with costs covered by the healthcare system.
Safety: Incidence of local recurrence and success of resection post-recurrence are monitored closely. If over 30% local recurrence occurs post-cCR, it may necessitate study termination at the center.
Data Collection: Clinical data are entered into electronic case report forms (eCRFs) based on primary healthcare documentation and stored pseudonymized on the primary research center's server. Molecular and pseudonymized clinical data are collected securely for analysis.
Sample Size Calculation and Statistical Analysis: A sample of 200 patients is estimated to provide sufficient data for the primary and key secondary endpoints and to meet other study objectives accurately.
Data Handling: Data handling adheres to privacy legislation, with information stored pseudonymously.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonoperative management | Experimental | Procedure: Nonoperative surveillanceThe patients presenting with complete clinical response undergo nonoperative management (i.e. watch \& wait) as surveillance for local regrowth or distant spread. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histopathological verification of primary rectal adenocarcinoma
- Complete clinical response at response assessment after neoadjuvant therapy
- Informed consent to organ preservation study
Key exclusion criteria (3 listed)
- Evidence of metastatic disease (fulfilling M-class criteria of TNM)
- No neoadjuvant therapy
- Inability to understand the information related to harms and benefits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nonoperative surveillanceAlso: Watch and Wait, Organ preservationClinical and imaging surveillance with digital rectal examination and/or endoscopy, rectal MRI and body CT | Procedure or surgery | Nonoperative management |
Primary outcome
Disease-free survival
Time frame: 2 years
Survival from complete clinical response to locoregional failure or distant metastases
12 secondary outcomes
Overall survival
Time frame: 5 years
TME-free survival
Time frame: 5 years
ctDNA-free survival
Time frame: 5 years
Post local regrowth disease-free survival
Time frame: 5 years
Post local regrowth overall survival
Time frame: 5 years
Local regrowth-free survival
Time frame: 5 years
Local recurrence-free survival
Time frame: 5 years
Distant metastases-free survival
Time frame: 5 years
Disease-free survival
Time frame: 5 years
Salvage rate after local regrowth
Time frame: 5 years
Quality of life score
Time frame: 5 years
Complication rates
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. The European Data Protection Regulation (GDPR) does not allow sharing other than anonymised patient level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Toni T Seppälä, MD, PhD principal investigator
Tampere University Hospital
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonoperative surveillance in people with Rectal Cancer and Rectal Adenocarcinoma, run by Tampere University Hospital at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Finland, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toni T Seppälä, MD, PhD (+358444722846, toni.seppala@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.