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.
Study Type
OBSERVATIONAL
Enrollment
100
Arizona Oncology Associates
Sedona, Arizona, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
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.
Time frame: From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised
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.
Time frame: From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised
Adverse events
Time frame: Duration of the study, up to 24 months
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.
Time frame: Baseline, month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment)
Patient satisfaction with treatment
Treatment Satisfaction Questionnaire for Medication (TQSM-9)
Time frame: Month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment)
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Oncology Hematology Care, Inc.
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