Pancreatic Neuroendocrine TumorPANTODONNCT07273409
Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not
A study testing Debulking surgery in people with Pancreatic Neuroendocrine Tumor, run by Uppsala University at 4 sites in Sweden.
Trial summary
Pancreatic neuroendocrine tumours (pan-NETs) are neoplasms arising from the endocrine cells of the pancreas. Although pan-NET are quite rare, the incidence is on the rise and together with other abdominal neuroendocrine tumours an approximate incidence in Sweden would be 850 patients per year extrapolating from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neuroendocrine Tumor
- What is being tested?
- Debulking surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesSweden
- Study dates
- 9 Jan 2026to 31 May 2033
- 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
- Pan- NET, ENETS/AJCC stage 4 determined by CT or PET/CT
- Primary tumour or metastases confirmed as Pancreatic NET GI-WHO grade 1-2 pan-NET by histology or cytology
- Age ≥ 18 years
- Written informed consent obtained
Who cannot join
- Subject not fit for surgery due to comorbidity or advanced age (reason to be specified)
- Risk of surgery deemed too high by MDT or Surgeon (reason to be specified)
- Previous surgery for pan-NET.
- Hormonal symptoms caused by a functional pan-NET, not controllable by medical therapy, indicating debulking surgery.
- Previously included in the current study.
- Pregnancy
- The study subject does not fit into either STRATA: a) STRATUM 1: Less than 70% of the total tumour volume can be debulked, b) STRATUM 2: no FDG-PET avid disease is observed OR all (100%) FDG-PET avid tumour is not resectable.
- Other reason in the opinion of the Principal Investigator (reason to be specified).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Anders Thornell, MD, PhD, +46 31 342 10 00, anders.thornell@vgregion.se
- Not yet recruiting
Skåne University Hospital
Lund
Erik Nordenström, MD, PhD, +46 46 17 23 05, erik.nordenstrom@med.lu.se
- Recruiting
Karolinska University Hospital
Stockholm
Carolina Nylen, MD, PhD, +46 8- 23 700 00, carolina.nylen@ki.se
- Recruiting
Uppsala University Hospital
Uppsala
Olov Norlén, MD, PhD, +46 18 611 00 00, olov.norlen@uu.se
About this study
Official title: PANcreatic Neuroendocrine Tumour - Optimal Surgical Debulking Or Not (PANTODON). A Prospective, Two Armed, Parallel, Randomised, Controlled International Multicentre Study on WHO Grade 1-2, Stage 4 Pancreatic NET
Pancreatic neuroendocrine tumours (pan-NETs) are neoplasms arising from the endocrine cells of the pancreas. Although pan-NET are quite rare, the incidence is on the rise and together with other abdominal neuroendocrine tumours an approximate incidence in Sweden would be 850 patients per year extrapolating from Norwegian data. Pan-NET are divided into symptomatic hormone producing tumours (such as insulinomas/glucagonomas/VIPomas) or non-functioning tumours that often are asymptomatic. As early symptoms often are lacking in non-functioning-pan-NET, many patients present with distant metastases and are thus beyond a curative surgical approach at the time of diagnosis. Metastatic non-functioning pan-NETs present a significant challenge and the optimal management remains a subject of debate.
This is a prospective, two armed, parallel, randomised, controlled, international multi-centre study, aiming to investigate if a near-total tumour debulking (intervention) in metastatic (stage 4) GI-WHO grade 1-2 pan- NET, with or without oncologic treatment, is superior to oncologic treatment alone (control), with regards to overall survival, health-related quality of life, participant performance status, time until hospitalisation, adverse event characteristics and cost in the short and long term.
- Conditions
- Pancreatic Neuroendocrine Tumor
- Being tested
- Debulking surgery
- Keywords
- Pan-NET, Stage 4, Debulking surgery, Non-functional Pan-NET, GI-WHO grade 1-2 Pan-NET
- Medical subject headings
- Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debulking surgeryProcedure or surgery
All subjects are divided into STRATUM 1 and STRATUM 2 prior to randomisation.
For subjects in STRATUM 1, the surgical resection, alone or in combination with ablative procedures, aim to achieve at least 70% debulking of the total tumour volume, with acceptable risk and acceptable functional liver remnant (FLR).
For subjects in STRATUM 2 the aim is to resect or ablate all FluDeoxyGlucose-Positron emission tomography (FDG-PET) avid disease with acceptable risk and acceptable FLR.
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Experimental | Debulking surgery followed by oncologic treatment according to standard routine. Further debulking surgery or ablation may be continued during follow-up to reduce tumour load. Receives: Procedure: Debulking surgery |
| Non-surgical group | No intervention | Oncologic treatment alone. No surgical or thermal ablative treatments will be planned after randomisation. Any surgical or ablative procedure for pan-NET that is performed after randomisation in the Non-surgical group is considered as a protocol deviation. However, such procedures may be carried out if clinically indicated and no other equivalent or better oncological options for treatment are available. The surgery is then documented as oncological treatment in eCRF and the subject will continue follow-up in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from randomisation to death.
Measured: Five years or until death.
Secondary outcomes (6)
Health economics
Estimation of total health economic costs for hospitalisation, ICU stay, and treatments given for the pan-NET disease in each group during follow-up.
Measured: Until end of trial.
Health-related quality of life
Data on health-related quality of life will be gathered with the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). The questionnaire is designed to measure cancer subjects' physical, psychological and social functions. It is composed of multi-item scales and single items.
Measured: The questionnaire will be filled in by the study subject before randomisation, at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.
Performance status
Performance status is measured using the Karnofsky performance status scale The scale ranges from 100 to 0, with higher scores indicating better functional status.
Measured: Assessed at screening, at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.
Days out of hospital
Total number of days alive outside hospital.
Measured: Assessed at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.
Days out of intensive care unit
Total number of days alive outside intensive care unit.
Measured: Assessed at 1 and 5 years.
Adverse events
Severe, life threatening and fatal adverse events possibly or probably related to pan-NET treatment during follow-up.
Measured: From randomisation until the end of the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start9 Jan 2026
- Primary completion31 May 2033 (estimated)
- Study completion31 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, two armed, parallel, randomised, controlled, international multi-centre study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olov Norlén, MD, PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273409
- Sponsor's protocol ID
- PANTODON/2025
- Acronym
- PANTODON
- Status last verified
- Jan 2026
- First submitted
- 24 Sep 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PANcreatic Neuroendocrine Tumour - Optimal Surgical Debulking Or Not (PANTODON). A Prospective, Two Armed, Parallel, Randomised, Controlled International Multicentre Study on WHO Grade 1-2, Stage 4 Pancreatic NET
- ClinicalTrials.gov ID
- NCT07273409
- Acronym / sponsor ID
- PANTODON / PANTODON/2025
- Conditions
- Pancreatic Neuroendocrine Tumor
- Keywords
- Pan-NET, Stage 4, Debulking surgery, Non-functional Pan-NET, GI-WHO grade 1-2 Pan-NET
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 31 May 2033 (estimated)
- Study completion
- 31 May 2033 (estimated)
- First posted
- 9 Dec 2025 (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.
Pancreatic neuroendocrine tumours (pan-NETs) are neoplasms arising from the endocrine cells of the pancreas. Although pan-NET are quite rare, the incidence is on the rise and together with other abdominal neuroendocrine tumours an approximate incidence in Sweden would be 850 patients per year extrapolating from Norwegian data. Pan-NET are divided into symptomatic hormone producing tumours (such as insulinomas/glucagonomas/VIPomas) or non-functioning tumours that often are asymptomatic. As early symptoms often are lacking in non-functioning-pan-NET, many patients present with distant metastases and are thus beyond a curative surgical approach at the time of diagnosis. Metastatic non-functioning pan-NETs present a significant challenge and the optimal management remains a subject of debate.
This is a prospective, two armed, parallel, randomised, controlled, international multi-centre study, aiming to investigate if a near-total tumour debulking (intervention) in metastatic (stage 4) GI-WHO grade 1-2 pan- NET, with or without oncologic treatment, is superior to oncologic treatment alone (control), with regards to overall survival, health-related quality of life, participant performance status, time until hospitalisation, adverse event characteristics and cost in the short and long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, two armed, parallel, randomised, controlled, international multi-centre study
| Arm | Type | Receives |
|---|---|---|
| Surgical group | Experimental | Procedure: Debulking surgeryDebulking surgery followed by oncologic treatment according to standard routine. Further debulking surgery or ablation may be continued during follow-up to reduce tumour load. |
| Non-surgical group | No intervention | –Oncologic treatment alone. No surgical or thermal ablative treatments will be planned after randomisation. Any surgical or ablative procedure for pan-NET that is performed after randomisation in the Non-surgical group is considered as a protocol deviation. However, such procedures may be carried out if clinically indicated and no other equivalent or better oncological options for treatment are available. The surgery is then documented as oncological treatment in eCRF and the subject will continue follow-up in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pan- NET, ENETS/AJCC stage 4 determined by CT or PET/CT
- Primary tumour or metastases confirmed as Pancreatic NET GI-WHO grade 1-2 pan-NET by histology or cytology
- Age ≥ 18 years
- Written informed consent obtained
Key exclusion criteria (8 listed)
- Subject not fit for surgery due to comorbidity or advanced age (reason to be specified)
- Risk of surgery deemed too high by MDT or Surgeon (reason to be specified)
- Previous surgery for pan-NET.
- Hormonal symptoms caused by a functional pan-NET, not controllable by medical therapy, indicating debulking surgery.
- Previously included in the current study.
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 |
|---|---|---|
| Debulking surgeryAll subjects are divided into STRATUM 1 and STRATUM 2 prior to randomisation. For subjects in STRATUM 1, the surgical resection, alone or in combination with ablative procedures, aim to achieve at least 70% debulking of the total tumour volume, with acceptable risk and acceptable functional liver remnant (FLR). For subjects in STRATUM 2 the aim is to resect or ablate all FluDeoxyGlucose-Positron emission tomography (FDG-PET) avid disease with acceptable risk and acceptable FLR. | Procedure or surgery | Surgical group |
Primary outcome
Overall survival
Time frame: Five years or until death.
Time from randomisation to death.
6 secondary outcomes
Health economics
Time frame: Until end of trial.
Health-related quality of life
Time frame: The questionnaire will be filled in by the study subject before randomisation, at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.
Performance status
Time frame: Assessed at screening, at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.
Days out of hospital
Time frame: Assessed at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.
Days out of intensive care unit
Time frame: Assessed at 1 and 5 years.
Adverse events
Time frame: From randomisation until the end of the study period.
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 22 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Olov Norlén, MD, PhD principal investigator
Uppsala University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debulking surgery in people with Pancreatic Neuroendocrine Tumor, run by Uppsala University at 4 sites in Sweden.
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 4 inclusion and 8 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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 Olov Norlén, Professor and Consultant, MD, PhD (+46 18 611 00 00, olov.norlen@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Five years or until death.). 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 22 Jan 2026.