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Community-based Neuroendocrine Tumor (NET) Research Study

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Ipsen

Status

Completed

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Study type

Observational

Funder types

Industry

Identifiers

NCT02730104
A-US-52030-340

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

100 participants in 5 patient groups

Cohort A: Patients with small bowel NET
Description:
Patients with small bowel NET (including appendiceal NETs)
Cohort B: Patients with gastric NET
Description:
Patients with gastric NET (gastroduodenal)
Cohort C: Patients with pancreatic NET
Cohort D: Patients with colorectal NET
Description:
Patients with colorectal NET (this includes mid-gut)
Cohort E: Unknown primary tumor

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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