NCT07273409 Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not
| NCT ID | NCT07273409 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University |
| Condition | Pancreatic Neuroendocrine Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-01-09 |
| Primary Completion | 2033-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-01-09 with a primary completion date of 2033-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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).
Contact & Investigator
Olov Norlén, MD, PhD
PRINCIPAL INVESTIGATOR
Uppsala University Hospital
Frequently Asked Questions
Who can join the NCT07273409 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Neuroendocrine Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07273409 currently recruiting?
Yes, NCT07273409 is actively recruiting participants. Contact the research team at olov.norlen@uu.se for enrollment information.
Where is the NCT07273409 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Lund, Sweden, Stockholm, Sweden, Uppsala, Sweden.
Who is sponsoring the NCT07273409 clinical trial?
NCT07273409 is sponsored by Uppsala University. The principal investigator is Olov Norlén, MD, PhD at Uppsala University Hospital. The trial plans to enroll 200 participants.