Near‑total debulking surgery versus non‑surgical management for metastatic pancreatic neuroendocrine tumours

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, two‑arm, parallel, international multicentre trial comparing near‑total tumour debulking surgery to non‑debulking management in adults with metastatic (stage 4) non‑functional pancreatic neuroendocrine tumours (GI‑WHO grade 1–2). Eligible patients are confirmed by histology or cytology and staged with CT or PET/CT, and are stratified based on resectability and FDG‑PET findings. The intervention arm undergoes surgical debulking aimed at removing the bulk of measurable disease while the control arm receives standard non‑surgical care determined by the treating team. Outcomes include measures of survival, disease progression, symptom control, and quality of life as specified in the protocol.

Why it matters

Who can join: the full rules

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).

Where it's running

• Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting
• Karolinska University Hospital
  Stockholm, Sweden Recruiting
• Uppsala University Hospital
  Uppsala, Sweden Recruiting
• Skåne University Hospital
  Lund, Sweden Not yet recruiting

Study contacts

• Principal investigator: Olov Norlén, MD, PhD — Uppsala University Hospital
• Study coordinator: Olov Norlén, Professor and Consultant, MD, PhD
• Email: olov.norlen@uu.se
• Phone: +46 18 611 00 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.