Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not

NCT07273409 | Recruiting DMC

• 1 other identifier: PANTODON/2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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

Keywords

Pan-NET; Stage 4; Debulking surgery; Non-functional Pan-NET; GI-WHO grade 1-2 Pan-NET

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Time from randomisation to death.

  Five years or until death.

Secondary Outcomes (6)

• Health economics

  Until end of trial.

• Health-related quality of life

  The questionnaire will be filled in by the study subject before randomisation, at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.

• Performance status

  Assessed at screening, at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.

• Days out of hospital

  Assessed at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.

• Days out of intensive care unit

  Assessed at 1 and 5 years.

Study Arms (2)

Surgical group

EXPERIMENTAL

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.

Procedure: Debulking surgery

Non-surgical group

NO INTERVENTION

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.

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.

Surgical group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala Clinical Research Center, Sweden: collaborator

Study Sites (4)

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Skåne University Hospital

Lund, Sweden

NOT YET RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Adenoma, Islet Cell

Interventions

Cytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Olov Norlén, MD, PhD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olov Norlén, Professor and Consultant, MD, PhD

CONTACT

+46 18 611 00 00; olov.norlen@uu.se

Carina Alvfors, Project Manager

CONTACT

+46 18 611 00 00; Carina.Alvfors@ucr.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, two armed, parallel, randomised, controlled, international multi-centre study

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: December 9, 2025
• Study Start: January 9, 2026
• Primary Completion (Estimated): May 31, 2033
• Study Completion (Estimated): May 31, 2033
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

SE (4)