Community-based Neuroendocrine Tumor (NET) Research Study

Study Overview
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Brief Summary
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The purpose of this trial is to assess time to disease progression of patients with locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors treated with Lanreotide Depot. This is an observational study therefore all data collected will be in accordance with the routine practice of physicians.

Official Title
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Prospective Observational Study in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors Treated With Lanreotide Depot in a US Community Oncology Setting

Conditions
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Gastroenteropancreatic Neuroendocrine Tumors

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed locally advanced or metastatic, well-differentiated neuroendocrine tumor (NET) of the small bowel, stomach, colon/rectum, or pancreas (low or intermediate grade; i.e. G1 or G2) Treatment with lanreotide depot (Somatostatin Analogue-naïve patients and patients with prior treatment with octreotide long-acting repeatable (LAR) are permitted) Radiographically measurable disease Has signed the most recent written Patient Informed Consent Form Exclusion Criteria: Known hypersensitivity to lanreotide Poorly differentiated or high grade carcinoma, or patients with neuroendocrine tumors not of lung or thymic origin Patients who have previously initiated treatment with lanreotide depot prior to the start of the study cannot have progressed between lanreotide initiation and study entry Significant history of uncontrolled cardiac disease (ie, myocardial infarction within 6 months prior to enrollment or has congestive heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities)

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A: Patients with small bowel NET<br>Patients with small bowel NET (including appendiceal NETs) | |
| Cohort B: Patients with gastric NET<br>Patients with gastric NET (gastroduodenal) | |
| Cohort C: Patients with pancreatic NET<br> | |
| Cohort D: Patients with colorectal NET<br>Patients with colorectal NET (this includes mid-gut) | |
| Cohort E: Unknown primary tumor<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression | Time to disease progression will be defined as the time from the first date of lanreotide, which may have occurred prior to study entry, to the date of first documented disease progression or the date of tumor-related death. In a living patient with no documented disease progression, or if the patient is lost to follow-up, disease progression will be censored at the date of the last evaluable scan. Patients who start a new treatment before they progress will be censored as of the date of last scan. Disease progression is defined for this study as both clinical dimensions of progression in conjunction with a treatment change. | From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival will be defined as the time from the first date of lanreotide, which may have occurred prior to study entry, to the date of death due to any cause or the last date the patient was known to be alive. | From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised | 
| Adverse events |  | Duration of the study, up to 24 months | 
| Change in flushing and diarrhea | To be assessed as present or not, and if present, as mild, moderate, or severe. At subsequent visits, it should be noted whether these symptoms are better, worse, or the same as at previous visit. | Baseline, month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment) | 
| Patient satisfaction with treatment | Treatment Satisfaction Questionnaire for Medication (TQSM-9) | Month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment) |