Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07273409

Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not

Led by Uppsala University · Updated on 2026-01-22

200

Participants Needed

4

Research Sites

385 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pancreatic neuroendocrine tumor (pan-NET), stage 4 by CT or PET/CT
  • Primary tumor or metastases confirmed as WHO grade 1-2 pan-NET by histology or cytology
  • Age 18 years or older
  • Written informed consent obtained
Not Eligible

You will not qualify if you...

  • Not fit for surgery due to other illnesses or advanced age
  • Surgery risk too high as decided by medical team or surgeon
  • Previous surgery for pan-NET
  • Hormonal symptoms from functional pan-NET not controlled by medication
  • Previously participated in this study
  • Pregnancy
  • Does not fit into either surgical treatment group (less than 70% tumor can be removed or FDG-PET active tumors not resectable)
  • Other reasons as decided by the Principal Investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Sahlgrenska University Hospital

Gothenburg, Sweden

Actively Recruiting

2

Skåne University Hospital

Lund, Sweden

Not Yet Recruiting

3

Karolinska University Hospital

Stockholm, Sweden

Actively Recruiting

4

Uppsala University Hospital

Uppsala, Sweden

Actively Recruiting

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Research Team

O

Olov Norlén, Professor and Consultant, MD, PhD

CONTACT

C

Carina Alvfors, Project Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not | DecenTrialz