Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not

Sponsor
Uppsala University
Study ID
NCT07273409
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 9, 2026
Status verified
Jan 2026
Primary completion
May 31, 2033
Completion
May 31, 2033

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Surgical 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.
  • No Intervention: Non-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 is then documented as oncological treatment in eCRF and the subject will continue follow-up in the study.

Primary Outcome Measure

Overall survival [ Time Frame: Five years or until death. ]

Central Contacts

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