Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Community-based Neuroendocrine Tumor (NET) Research Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02730104
Recruitment Status : Active, not recruiting
First Posted : April 6, 2016
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease
Gastroenteropancreatic Neuroendocrine Tumors

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : November 23, 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Group/Cohort
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



Primary Outcome Measures :
  1. Time to disease progression [ Time Frame: From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised ]
    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.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised ]
    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.

  2. Adverse events [ Time Frame: Duration of the study, up to 24 months ]
  3. Change in flushing and diarrhea [ Time Frame: Baseline, month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment) ]
    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.

  4. Patient satisfaction with treatment [ Time Frame: Month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment) ]
    Treatment Satisfaction Questionnaire for Medication (TQSM-9)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730104


Locations
Layout table for location information
United States, Arizona
Arizona Oncology Associates
Sedona, Arizona, United States, 86336
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Illinois
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
United States, Ohio
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45230
United States, Texas
Texas Oncology - Beaumont, Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States, 77702
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology - Denton South
Denton, Texas, United States, 76210
Texas Oncology
Houston, Texas, United States, 75702
Texas Oncology-Tyler
Tyler, Texas, United States, 75702
Texas Oncology - Deke Slayton Cancer Center
Webster, Texas, United States, 77598
United States, Washington
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Ipsen
Investigators
Layout table for investigator information
Study Director: Ipsen Medical Director Ipsen

Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02730104     History of Changes
Other Study ID Numbers: A-US-52030-340
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases