Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUppsala University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Debulking surgery

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators