Study Comparing Surgery Plus Standard Treatment Versus Standard Treatment Alone for Advanced Pancreatic Neuroendocrine Tumors Grade 1-2, Stage 4

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.

Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not