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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates | Sedona | Arizona | 86336 | United States | ||
| Rocky Mountain Cancer Centers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36136274 | Derived | 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. |
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| Adverse events |
| 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. | 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) | Month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment) |
| 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 |