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Completed

NCT Number: NCT02730104

Community-based Neuroendocrine Tumor (NET) Research Study

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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Key information

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arizona Oncology Associates, Sedona, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Prospective Observational Study in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors Treated With Lanreotide Depot in a US Community Oncology Setting

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2016
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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