Non-functioning Pancreatic Neuroendocrine Tumors in MEN1: Somatostatin Analogs Versus NO Treatment (SANO)
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|ClinicalTrials.gov Identifier: NCT02705651|
Recruitment Status : Not yet recruiting
First Posted : March 10, 2016
Last Update Posted : April 8, 2019
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.
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).
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neuroendocrine Tumors in MEN1||Drug: Somatostatin-Analog||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2024|
A long acting somatostatin analog will be applied.
A long-acting somatostatin-analog will be applied.
No Intervention: No treatment
This arm will be be the observational control according to the endpoints of the study. No intervention will be made.
- Growth rate of the tumor in mm [ Time Frame: 5 years ]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.
- Documentation of new tumors [ Time Frame: 5 years ]In intervals of 6 months radiologic examinations of the pancreas will be made, thereby newly developed tumors can be documented and will be compared between the groups.
- Documentation of lymph node and/or distant metastases [ Time Frame: 5 years ]Functional imaging will be made in intervals of 12 months. With this modality newly arisen metastatic lesions can be documented. The development of those lesions will be compared between the groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705651
|Contact: Andreas Selberherr, M.D.||+43(1)40400-69430||Andreas.Selberherr@meduniwien.ac.at|
|Contact: Bruno Niederle, M.D.||+43(1)40400-69430||Bruno.Niederle@meduniwien.ac.at|
|Principal Investigator:||Andreas Selberherr, M.D.||Medical University of Vienna|