Non-functioning Pancreatic Neuroendocrine Tumors in MEN1: Somatostatin Analogs Versus NO Treatment
Status:
Not yet recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
Summary
A.Background
More than 90% of patients with multiple endocrine neoplasia type 1 (MEN1) develop multiple
pancreatic neuroendocrine tumors (pNETs). These tumors are the most common cause for
premature death in MEN1.
While functioning pNETs must be treated to reduce or cure hormonal excess, the procedures for
non-functioning pNETs are yet under discussion. Treatment ranges from watchful waiting to
subtotal and total pancreatectomy. The latter may represent an "overtreatment", resulting in
general complications and diabetic metabolic status.
The effect of somatostatin analogues (SAs) has shown promising results with regard to
progression of non-functioning duodeno-pancreatic NETs. Treatment with SAs is highly safe and
effective, resulting in long-time suppression of tumor growth.
B. Aim
In this study of MEN1 patients with non-functioning pNETs, the benefits of somatostatin
analogs" (SAs; group 1) compared to "no treatment" (group 2) will be analyzed with regard to
progression (tumor growth; development of new [functioning and non-functioning]
neuroendocrine tumors and regional/distant metastasis).
C. Implementation
Patients will either receive Somatostatin Analogs (SAs) or no treatment. The observation
period will be 60 months. The increase of tumor size and development of new tumors or
metastasis will be monitored.