Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not

NCT ID: NCT07273409

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-09
• Study Completion Date: 2033-05-31

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.

Conditions

Pancreatic Neuroendocrine Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Debulking surgery

Intervention Type: 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.

Interventions

Debulking surgery

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.

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala Clinical Research Center, Sweden

UNKNOWN

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olov Norlén, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status: RECRUITING

Skåne University Hospital

Lund, , Sweden

Site Status: NOT_YET_RECRUITING

Karolinska University Hospital

Stockholm, , Sweden

Site Status: RECRUITING

Uppsala University Hospital

Uppsala, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Olov Norlén, Professor and Consultant, MD, PhD

Role: CONTACT

olov.norlen@uu.se

+46 18 611 00 00

Carina Alvfors, Project Manager

Role: CONTACT

Carina.Alvfors@ucr.uu.se

+46 18 611 00 00

Facility Contacts

Anders Thornell, MD, PhD

Role: primary

anders.thornell@vgregion.se

+46 31 342 10 00

Erik Nordenström, MD, PhD

Role: primary

erik.nordenstrom@med.lu.se

+46 46 17 23 05

Carolina Nylen, MD, PhD

Role: primary

carolina.nylen@ki.se

+46 8- 23 700 00

Olov Norlén, MD, PhD

Role: primary

olov.norlen@uu.se

+46 18 611 00 00

Other Identifiers

PANTODON/2025

Identifier Type: -

Identifier Source: org_study_id