Near‑total debulking surgery versus non‑surgical management for metastatic pancreatic neuroendocrine tumours
PANcreatic Neuroendocrine Tumour - Optimal Surgical Debulking Or Not (PANTODON). A Prospective, Two Armed, Parallel, Randomised, Controlled International Multicentre Study on WHO Grade 1-2, Stage 4 Pancreatic NET
This study will test whether removing most of the tumour (near‑total debulking surgery) helps adults with stage 4 non‑functional pancreatic neuroendocrine tumours live longer or feel better compared with not doing debulking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Academic / other |
| Locations | 4 sites (Gothenburg and 3 other locations) |
| Trial ID | NCT07273409 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, two‑arm, parallel, international multicentre trial comparing near‑total tumour debulking surgery to non‑debulking management in adults with metastatic (stage 4) non‑functional pancreatic neuroendocrine tumours (GI‑WHO grade 1–2). Eligible patients are confirmed by histology or cytology and staged with CT or PET/CT, and are stratified based on resectability and FDG‑PET findings. The intervention arm undergoes surgical debulking aimed at removing the bulk of measurable disease while the control arm receives standard non‑surgical care determined by the treating team. Outcomes include measures of survival, disease progression, symptom control, and quality of life as specified in the protocol.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed stage 4 non‑functional pancreatic NET (GI‑WHO grade 1–2) who are medically fit for major abdominal surgery and can provide informed consent are the intended participants.
Not a fit: Patients who are unfit for surgery, pregnant, have prior pancreatic NET surgery, have uncontrolled hormonal symptoms from a functional tumour, or whose disease cannot be reasonably debulked are unlikely to benefit from the surgical arm.
Why it matters
Potential benefit: If successful, this approach could prolong survival, slow disease progression, and reduce tumour‑related symptoms for selected patients.
How similar studies have performed: Retrospective and observational series have suggested symptom relief and possible survival benefit from debulking in neuroendocrine tumours, but randomized controlled evidence in metastatic pancreatic NET is currently lacking.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Gothenburg and 3 other locations
- 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)
Study contacts
- Principal investigator: Olov Norlén, MD, PhD — Uppsala University Hospital
- Study coordinator: Olov Norlén, Professor and Consultant, MD, PhD
- Email: olov.norlen@uu.se
- Phone: +46 18 611 00 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.