Community-based Neuroendocrine Tumor (NET) Research Study
Prospective Observational Study in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors Treated With Lanreotide Depot in a US Community Oncology Setting
1 other identifier
observational
100
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2015
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 23, 2015
CompletedFirst Submitted
Initial submission to the registry
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2020
CompletedJune 26, 2020
June 1, 2020
4.5 years
April 1, 2016
June 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Overall survival
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
Baseline, month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment)
Patient satisfaction with treatment
Month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment)
Study Arms (5)
Cohort A: Patients with small bowel NET
Patients with small bowel NET (including appendiceal NETs)
Cohort B: Patients with gastric NET
Patients with gastric NET (gastroduodenal)
Cohort C: Patients with pancreatic NET
Cohort D: Patients with colorectal NET
Patients with colorectal NET (this includes mid-gut)
Cohort E: Unknown primary tumor
Eligibility Criteria
Community sample
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (12)
Arizona Oncology Associates
Sedona, Arizona, 86336, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45230, United States
Texas Oncology - Beaumont, Mamie McFaddin Ward Cancer Center
Beaumont, Texas, 77702, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, 75231, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology - Denton South
Denton, Texas, 76210, United States
Texas Oncology
Houston, Texas, 75702, United States
Texas Oncology-Tyler
Tyler, Texas, 75702, United States
Texas Oncology - Deke Slayton Cancer Center
Webster, Texas, 77598, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902, United States
Related Publications (1)
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.
PMID: 36136274DERIVED
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2016
First Posted
April 6, 2016
Study Start
November 23, 2015
Primary Completion
May 13, 2020
Study Completion
May 13, 2020
Last Updated
June 26, 2020
Record last verified: 2020-06