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NCT Number: NCT07273409

Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

Debulking surgery

Procedure

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.

Primary outcomes

  1. Overall survival

    Time frame: Five years or until death.

    Time from randomisation to death.

Secondary outcomes

  1. Health economics

    Time frame: Until end of trial.

    Estimation of total health economic costs for hospitalisation, ICU stay, and treatments given for the pan-NET disease in each group during follow-up.

  2. 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.

    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.

  3. 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.

    Performance status is measured using the Karnofsky performance status scale The scale ranges from 100 to 0, with higher scores indicating better functional status.

  4. 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.

    Total number of days alive outside hospital.

  5. Days out of intensive care unit

    Time frame: Assessed at 1 and 5 years.

    Total number of days alive outside intensive care unit.

  6. Adverse events

    Time frame: From randomisation until the end of the study period.

    Severe, life threatening and fatal adverse events possibly or probably related to pan-NET treatment during follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Carina Alvfors, Project Manager

CONTACT

[email protected]

+46 18 611 00 00

Olov Norlén, Professor and Consultant, MD, PhD

CONTACT

[email protected]

+46 18 611 00 00

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study 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

Acronym: PANTODON

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Dec 9, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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