Clinical trial · Interventional
Non-functioning Pancreatic Neuroendocrine Tumors in MEN1: Somatostatin Analogs Versus NO Treatment
Non-functioning Pancreatic Neuroendocrine Tumors (NF-pNETs) in Multiple Endocrine Neoplasia Type 1 (MEN1) Treated With Somatostatin Analogs (SA) Versus NO Treatment - a Prospective, Randomized, Controlled Multicenter Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neuroendocrine Tumors in MEN1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Somatostatin-Analog | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Somatostatin-Analog
- description
- A long acting somatostatin analog will be applied.
- interventionNames
- Drug: Somatostatin-Analog
- type
- NO_INTERVENTION
- label
- No treatment
- description
- This arm will be be the observational control according to the endpoints of the study. No intervention will be made.
Primary outcomes (1)
- measure
- Growth rate of the tumor in mm
- timeFrame
- 5 years
- description
- The growth rate of the leading lesion (≥20mm in diameter) will be radiologically controlled in six-monthly intervals. Growth rate will be compared between the groups.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Verified MEN1 syndrome by molecular genetics (known mutation)
* Non-functioning pNET
* Largest ("leading") pancreatic tumor with ≤20 mm in diameter and (if present) one small tumor \<15 mm in diameter as reference lesion
* G1 or G2 (Ki-67 ≤ 10%) according to endoscopic ultrasound/fine-needle aspiration (EUS/FNA) acquired by 19-gauge needle
* Functional imaging: Ga68-DOTA-conjugated peptide positron emission tomography (PET) computed tomography (CT) or preferably Ga68-DOTA-conjugated peptide magnetic resonance imaging (MRI)
* Tumor(s) limited to the pancreas (N0, M0)
Exclusion Criteria:
* Functioning tumor - hormone excess
* Neuroendocrine carcinoma (G3)
* Metastatic disease (N1, M1)References
Publications (13)
- BACKGROUNDDean PG, van Heerden JA, Farley DR, Thompson GB, Grant CS, Harmsen WS, Ilstrup DM. Are patients with multiple endocrine neoplasia type I prone to premature death? World J Surg. 2000 Nov;24(11):1437-41. doi: 10.1007/s002680010237. PMID 11038219
- BACKGROUNDIto T, Igarashi H, Uehara H, Berna MJ, Jensen RT. Causes of death and prognostic factors in multiple endocrine neoplasia type 1: a prospective study: comparison of 106 MEN1/Zollinger-Ellison syndrome patients with 1613 literature MEN1 patients with or without pancreatic endocrine tumors. Medicine (Baltimore). 2013 May;92(3):135-181. doi: 10.1097/MD.0b013e3182954af1. PMID 23645327
- BACKGROUNDDoherty GM, Thompson NW. Multiple endocrine neoplasia type 1: duodenopancreatic tumours. J Intern Med. 2003 Jun;253(6):590-8. doi: 10.1046/j.1365-2796.2003.01163.x. PMID 12755954
- BACKGROUNDGauger PG, Thompson NW. Early surgical intervention and strategy in patients with multiple endocrine neoplasia type 1. Best Pract Res Clin Endocrinol Metab. 2001 Jun;15(2):213-23. doi: 10.1053/beem.2001.0136. PMID 11472035
- BACKGROUNDKouvaraki MA, Shapiro SE, Cote GJ, Lee JE, Yao JC, Waguespack SG, Gagel RF, Evans DB, Perrier ND. Management of pancreatic endocrine tumors in multiple endocrine neoplasia type 1. World J Surg. 2006 May;30(5):643-53. doi: 10.1007/s00268-006-0360-y. PMID 16680581
- BACKGROUNDAkerstrom G, Hessman O, Skogseid B. Timing and extent of surgery in symptomatic and asymptomatic neuroendocrine tumors of the pancreas in MEN 1. Langenbecks Arch Surg. 2002 Mar;386(8):558-69. doi: 10.1007/s00423-001-0274-6. Epub 2002 Jan 24. PMID 11914931
- BACKGROUNDGauger PG, Doherty GM, Broome JT, Miller BS, Thompson NW. Completion pancreatectomy and duodenectomy for recurrent MEN-1 pancreaticoduodenal endocrine neoplasms. Surgery. 2009 Oct;146(4):801-6; discussion 807-8. doi: 10.1016/j.surg.2009.06.038.