Actively Recruiting
PANcreatic Neuroendocrine Tumour - Optimal Surgical Debulking Or Not (PANTODON) An International Randomised Controlled Study on WHO Grade 1-2, Stage 4 Pancreatic NET
Led by Uppsala University · Updated on 2026-01-22
200
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Pancreatic neuroendocrine tumours (pan-NETs) are rare tumors that arise from hormone-producing cells in the pancreas. These tumors can be hormone-producing with symptoms or non-functioning and often symptomless, leading to late diagnosis with advanced disease. This trial investigates whether near-total tumor removal (debulking surgery) combined with standard cancer treatment improves survival and quality of life compared to cancer treatment alone in patients with advanced stage 4, WHO grade 1-2 pan-NETs. Participants are randomly assigned to one of two groups. The experimental group receives debulking surgery aiming to remove at least 70% of tumor volume or all FDG-PET positive tumor tissue, followed by standard oncologic treatments. Surgery or tumor ablation may continue during follow-up to reduce tumor burden. The control group receives standard oncologic treatment alone without planned surgery or ablation after randomization, though surgery may be performed if medically necessary. During the study, participants will be monitored for overall survival up to five years or until death. Researchers will assess quality of life using questionnaires, performance status, days spent outside hospital or intensive care, adverse events, and health economic outcomes at multiple time points up to five years. This long-term follow-up will provide detailed information on the benefits and risks of adding surgery to standard treatment for metastatic pan-NET.
CONDITIONS
Brief Title
Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with stage 4 pancreatic neuroendocrine tumor confirmed by CT or PET/CT
- Tumor confirmed as WHO grade 1-2 pancreatic NET by biopsy
- Age 18 years or older
- Able to provide written informed consent
You will not qualify if you...
- Not fit for surgery due to other health conditions or advanced age
- Surgery risk considered too high by medical team
- Prior surgery for pancreatic neuroendocrine tumor
- Uncontrolled hormonal symptoms from functional pancreatic NET
- Previously participated in this study
- Pregnant
- Tumor cannot be removed as defined by study strata criteria
- Other reasons as decided by the main investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Variable depending on surgical and recovery needs
Participants in the surgical group undergo debulking surgery aiming to remove a significant portion of the tumor followed by immediate post-operative care.
1 surgery visit and several immediate post-operative assessments
Duration - Up to 5 years or until death
Participants receive oncologic treatment according to standard routine. In the surgical group, further debulking surgery or ablation may continue during follow-up to reduce tumor load. Participants in the non-surgical group receive oncologic treatment alone without planned surgical interventions.
Regular follow-up visits at 3 months (+/- 2 weeks), 6 months, and annually up to 5 years (+/- 4 weeks) for assessments including quality of life and performance status
Duration - Up to 5 years
Participants are monitored for overall survival, adverse events, and health outcomes including days out of hospital and intensive care unit over the study period.
Scheduled visits at 1 and 5 years for additional assessments
Trial Site Locations
Total: 4 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
2
Skåne University Hospital
Lund, Sweden
Not Yet Recruiting
3
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
4
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
Research Team
O
Olov Norlén, Professor and Consultant, MD, PhD
C
Carina Alvfors, Project Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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