Community-based Neuroendocrine Tumor (NET) Research Study

Gastroenteropancreatic Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730104
• Other study ID #: A-US-52030-340
• Status: Completed
• Start date: November 23, 2015
• Est. completion date: May 13, 2020

Study information

• Verified date: June 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 13, 2020
• Est. primary completion date: May 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Gastroenteropancreatic Neuroendocrine Tumors
• Intestinal Neoplasms
• Neuroendocrine Tumors
• Pancreatic Neoplasms
• Stomach Neoplasms

Locations

Country	Name	City	State
United States	Illinois Cancer Specialists	Arlington Heights	Illinois
United States	Texas Oncology - Beaumont, Mamie McFaddin Ward Cancer Center	Beaumont	Texas
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology - Dallas Presbyterian Hospital	Dallas	Texas
United States	Texas Oncology - Denton South	Denton	Texas
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Texas Oncology	Houston	Texas
United States	Arizona Oncology Associates	Sedona	Arizona
United States	Texas Oncology-Tyler	Tyler	Texas
United States	Texas Oncology - Deke Slayton Cancer Center	Webster	Texas
United States	Yakima Valley Memorial Hospital/North Star Lodge	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Adverse events		Duration of the study, up to 24 months
Secondary	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)
Secondary	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)