Resection of the Primary Tumor vs. Systemic Treatment Alone for Patients With Small Intestinal Neuroendocrine Tumors and Unresectable Metastases: a Europe-wide Study

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jan 15, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether removing the primary tumor in patients with small intestinal neuroendocrine tumors (siNETs) that have spread (metastasized) improves their chances of living longer and prevents complications, like bowel blockages, compared to those who do not have surgery. Currently, it’s unclear if surgery helps patients who aren’t experiencing symptoms. The study will focus on patients diagnosed between 2005 and 2019 who have siNETs that cannot be cured by surgery, specifically excluding those who have other significant health issues or are showing symptoms like intestinal obstruction or bleeding.

Eligible participants can expect to be part of a large European study that aims to gather important information about the benefits and risks of surgery versus no surgery in this particular situation. The results of this study could help shape future guidelines for treating siNETs and provide clearer answers for patients and their families about the best treatment options. If you’re interested in being part of this trial, it's important to know that it’s not yet open for recruitment, but more information will be available once it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - All patients with siNET and non-curative metastatic disease between 01.01.2005 and 31.12.2019 will be included.
• Exclusion Criteria:
• • - All patients with siNET G3, resectable metastatic disease and/or non-resectable primary tumor at initial diagnosis will be excluded. Furthermore, symptomatic patients (small intestinal obstruction, bleeding) or when imaging suggests that obstruction will probably occur (bowel dilatation, mesenteric fibrosis) at initial diagnosis will be excluded. Patients with diarrhea, flushing, or abdominal pain will not be excluded.
• • Patients with a documented rejection for a further use of their data for scientific purposes will also be excluded.