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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 : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Andreas Selberherr, Medical University of Vienna

Brief 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.


Condition or disease Intervention/treatment Phase
Pancreatic Neuroendocrine Tumors in MEN1 Drug: Somatostatin-Analog Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : October 2018
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2024


Arm Intervention/treatment
Experimental: Somatostatin-Analog
A long acting somatostatin analog will be applied.
Drug: Somatostatin-Analog
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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

Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Andreas Selberherr, M.D. Medical University of Vienna

Publications:

Responsible Party: Dr. Andreas Selberherr, M.D., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02705651     History of Changes
Other Study ID Numbers: SAN_001/16
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neuroendocrine Tumors
Adenoma, Islet Cell
Multiple Endocrine Neoplasia
Multiple Endocrine Neoplasia Type 1
Pancreatic Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenoma
Neoplasms, Glandular and Epithelial
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs