Clinical Trial: Community-based Neuroendocrine Tumor (NET) Research Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Prospective Observational Study in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors Treated With Lanreotide Depot in a US Communit

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.

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • Adverse events [ Time Frame: Duration of the study, up to 24 months ]
  • 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.
  • 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 (abbreviated TQSM-9)


Original Secondary Outcome: Same as current

Information By: Ipsen

Dates:
Date Received: April 1, 2016
Date Started: November 2015
Date Completion: December 2019
Last Updated: December 28, 2016
Last Verified: December 2016