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Clinical Trial NCT07273409 (PANTODON) for Pancreatic Neuroendocrine Tumor is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not (PANTODON) 200 International Overall Survival
Clinical Trial NCT07273409 (PANTODON) is an interventional study for Pancreatic Neuroendocrine Tumor that is recruiting. It started on 9 January 2026 with plans to enroll 200 participants. Led by Uppsala University, it is expected to complete by 31 May 2033. The latest data from ClinicalTrials.gov was last updated on 22 January 2026.
Brief 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 Norwegian data. Pan-NET are divided into symptomatic hormone producing tumours (such as insulinomas/glucago...Show More
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
Conditions
Pancreatic Neuroendocrine TumorOther Study IDs
- PANTODON
- PANTODON/2025
NCT ID Number
Start Date (Actual)
2026-01-09
Last Update Posted
2026-01-22
Completion Date (Estimated)
2033-05-31
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Pan-NET
Stage 4
Debulking surgery
Non-functional Pan-NET
GI-WHO grade 1-2 Pan-NET
Stage 4
Debulking surgery
Non-functional Pan-NET
GI-WHO grade 1-2 Pan-NET
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSurgical group 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. | Debulking 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...Show More |
No InterventionNon-surgical group 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 ...Show More | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall survival | Time from randomisation to death. | Five years or until death. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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. | 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. | 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. | 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. | From randomisation until the end of the study period. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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).
Study Central Contact
Contact: Olov Norlén, Professor and Consultant, MD, PhD, +46 18 611 00 00, [email protected]
Contact: Carina Alvfors, Project Manager, +46 18 611 00 00, [email protected]
4 Study Locations in 1 Countries
Sahlgrenska University Hospital, Gothenburg, Sweden
Anders Thornell, MD, PhD, Contact, +46 31 342 10 00, [email protected]
Recruiting
Skåne University Hospital, Lund, Sweden
Erik Nordenström, MD, PhD, Contact, +46 46 17 23 05, [email protected]
Not yet recruiting
Karolinska University Hospital, Stockholm, Sweden
Carolina Nylen, MD, PhD, Contact, +46 8- 23 700 00, [email protected]
Recruiting
Uppsala University Hospital, Uppsala, Sweden
Olov Norlén, MD, PhD, Contact, +46 18 611 00 00, [email protected]
Recruiting