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OpenTrials
Completed

NCT Number: NCT03017690

Lanreotide and Octreotide Long Acting Release (LAR) for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

An observational time and motion study in a clinical oncology setting is utilized in order to measure and compare product attributes and overall product efficiency between lanreotide and octreotide LAR.

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Key information

Conditions

Gastroenteropancreatic Neuroendocrine Tumor Gastro-enteropancreatic neuroendocrine tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Arizona Cancer Center, Tucson, 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

  • Men and women must be 18 years of age or older
  • A current diagnosis of advanced, unresectable GEP-NET
  • Provided written informed consent to participate in the study
  • Currently receiving lanreotide or octreotide LAR and has received at least one prior injection of current somatostatin analogues (SSA).

Exclusion criteria

  • Receiving treatment with lanreotide or octreotide LAR as part of a clinical trial
  • Scheduled to receive a dose of lanreotide or octreotide LAR that would necessitate more than 1 injection on the same day
  • Scheduled to receive any other treatment in the infusion center/room on the same day and as part of the same appointment
  • Known hypersensitivity to somatostatin analogues

Treatment and study plan

Primary outcomes

  1. The total time for product preparation and administration

    Time frame: Day 1

    Total drug delivery time

Secondary outcomes

  1. Total patient wait time for administration

    Time frame: Day 1

    For the purposes of this study, "total patient wait time" refers to the time the patient checks in at the infusion room until completion of drug administration and discharge of the patient from the infusion room.

  2. Number of clogging episodes

    Time frame: Day 1

    The number of clogging episodes for lanreotide and octreotide LAR will be recorded and compared.

  3. Healthcare resource utilization

    Time frame: Day 1

    The materials used for the preparation of lanreotide and octreotide LAR will be recorded and compared.

  4. Pharmacist and/or nurse satisfaction and product preference

    Time frame: Day 1 and at the end of the study (approximately 3 months)

    Assessed by pharmacist and/or nurse completing questionnaire

  5. Patient satisfaction

    Time frame: Day 1

    Assessed by patient completing questionnaire

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Lanreotide and Octreotide LAR for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): An Observational Time and Motion Analysis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 11, 2017
Registry last updated
Dec 21, 2018

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

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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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