Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs

Study Overview
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Brief Summary
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This study evaluates the efficacy of Long-acting Somastostatin analogs as treatment for type I gastric neuroendocrine tumors.

Official Title
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An Observational Study Investigating Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs

Conditions
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Gastric NET

Intervention / Treatment
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* Drug: Octreotide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic diagnosis of gastric neuroendocrine tumor. Clinical diagnosis of Type I gastric NET: neuroendocrine tumor arising from atrophic body gastritis (ABG diagnosis should be based on hypergastrinemia and histological confirmation of gastric body atrophy on multiple biopsies performed in gastric antrum and body). Previous esophagogastroduodenoscopy: all visible NETs resected with R0 margin, confirmed no visible gastric NETs left, multiple biopsies taken to evaluate gastric atrophy and ECL status. No tumor metastases confirmed by endoscopic ultrasonography, CT scan or somatostatin receptor scintigraphy. SSA therapy is recommended by physician for disease management, and has not yet begun. Written informed consent obtained prior to treatment to be consistent with local regulatory requirements. Exclusion Criteria: Pathological grading as G3 NET (Ki-67>20%). Patients with a known hypersensitivity to somatostatin analogs. Known gallbladder or bile duct disease, acute or chronic pancreatitis. Known medical condition related with prolonged QT interval. Pregnant or lactating women. Patients with serious complicated infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy. Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for > 5 years will be allowed to enter the trial. Patients with a history of non-compliance to medical regimens.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Octreotide|Patients will receive 6-12 monthly injections every 28 (+/- 3) days.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical symptoms | Measured by a questionnaire, including whether the patient presents with dyspepsia, abdominal pain, cramps, bloating, nausea, vomiting, lack of appetite, facial flushing. | 6 months to 1 year | 
| Concentration of serum Gastrin | Concentration of serum Gastrin after 12 hours of fasting | 6 months to 1 year | 
| Enterochromaffin-like cell (ECL) status | Normal Hyperplasia: ECL cell proliferation with a diameter <150 μm, distinguished in: normal pattern/simple hyperplasia, linear, micronodular and adenomatoid hyperplasia. Dysplasia: ECL cell proliferation >150 but <500 μm. Type I gastric carcinoid: ECL proliferation >500 μm. | 6 months to 1 year | 
| Presence of side-effects of Octreotide | Measured by a questionnaire for patients and clinician's report. Including: hypersensitivity, endocrine disorders (abnormal thyroid functions), metabolism and nutrition disorders (abnormal blood glucose), headache, bradycardia or tachycardia, dyspnea, gastrointestinal disorders (diarrhea, abdominal pain, nausea, constipation, flatulence), hepatobiliary disorders, skin disorders, injection site reaction. | 6 months to 1 year |