Clinical trial NCT02730104: Community-based Neuroendocrine Tumor (NET) Research Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteropancreatic Neuroendocrine Tumors
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2016-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Time to disease progression
timeFrame: From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised
Secondary outcomes:
measure: Overall survival
timeFrame: From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised
measure: Adverse events
timeFrame: Duration of the study, up to 24 months
measure: Change in flushing and diarrhea
timeFrame: Baseline, month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment)
measure: Patient satisfaction with treatment
timeFrame: Month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment)
Other outcomes:
Locations:
city: Sedona
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Beaumont
country: United States
facility: Texas Oncology - Beaumont, Mamie McFaddin Ward Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas Presbyterian Hospital
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Denton
country: United States
facility: Texas Oncology - Denton South
state: Texas
city: Houston
country: United States
facility: Texas Oncology
state: Texas
city: Tyler
country: United States
facility: Texas Oncology-Tyler
state: Texas
city: Webster
country: United States
facility: Texas Oncology - Deke Slayton Cancer Center
state: Texas
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Star Lodge
state: Washington
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Paulson S, Ray D, Aranha S, Scales A, Wang Y, Liu E. Lanreotide Depot to Treat Gastroenteropancreatic Neuroendocrine Tumors in a US Community Oncology Setting: A Prospective, Observational Study. Oncol Ther. 2022 Dec;10(2):463-479. doi: 10.1007/s40487-022-00208-1. Epub 2022 Sep 22.