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Completed

NCT Number: NCT03112694

Switching From Octreotide to Lanreotide - A Look Back at Patients With Neuroendocrine Tumors

The purpose of this study is to understand how people with neuroendocrine tumors respond to treatment with lanreotide after having received treatment with octreotide.

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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moffitt Cancer Center, Tampa, Florida, 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

  • Males and females age 18 years or older at time of locally advanced or metastatic diagnosis
  • Patients with a confirmed diagnosis of locally advanced or metastatic Gastroenteropancreatic neuroendocrine tumour (GEP-NET)
  • Patients who switched treatment from long acting octreotide LAR to lanreotide, where both treatments were received for the treatment of locally advanced or metastatic GEP-NET. i. Treatment with long acting octreotide LAR monotherapy for at least 90-days before treatment with lanreotide monotherapy (rescue SSA# use permitted). ii. Treatment with lanreotide monotherapy for at least 90-days after treatment with long acting octreotide monotherapy (rescue SSA# use permitted)

Exclusion criteria

  • Patients with other malignant disease
  • Patients who participated in a concomitant clinical trial related to treatment of GEP-NET
  • Patients being treated with a Somatostatin analogue (SSA) in combination with other NET treatments excluding rescue SSA#
  • Patients who received other primary treatment (e.g., targeted therapy, chemotherapy) for GEP-NET during the interval between octreotide and lanreotide
  • Patients with NET familial genetic syndrome (i.e., MEN1)

Treatment and study plan

Data Collection

Other

This is a non-interventional study, the decision to prescribe the product would have been taken prior to, and independently from the decision to enrol the patient.

Primary outcomes

  1. Response to treatment

    Time frame: 4 months (data collection duration)

    Evaluated as responsive disease (i.e., complete response, partial response), stable disease or progressive disease at the last tumor assessment while on treatment with lanreotide (based on tumor imaging, symptoms, biomarker(s) and/or clinical judgement)

Secondary outcomes

  1. Progression-free survival, after treatment with octreotide

    Time frame: 4 months (data collection duration)

    For evaluating progression-free survival events will include radiographic progression per investigator, biomarker progression per investigator, symptom progression per investigator, and death. Adverse events (AEs) will not be considered as an event.

  2. Duration of response to lanreotide, after treatment with octreotide

    Time frame: 4 months (data collection duration)

    For evaluating duration of response events will include radiographic progression per investigator, biomarker progression per investigator, symptom progression per investigator, AEs, and death. Open ended responses will be reviewed during the analysis and determined to be an eligible "event" or not at that time.

  3. Duration of treatment with octreotide and duration of treatment with lanreotide

    Time frame: 4 months (data collection duration)

    Duration of octreotide treatment assessed as time from start of octreotide treatment to stop of octreotide treatment. Duration of lanreotide treatment assessed as time from lanreotide initiation to end of lanreotide treatment (censored at the date of last administration (+lanreotide frequency) for patients who had ongoing lanreotide treatment).

  4. Severity of Adverse Events

    Time frame: 4 months (data collection duration)

    Summarized separately during treatment with octreotide and during treatment with lanreotide, as available

  5. Reasons for switching from octreotide to lanreotide

    Time frame: 4 months (data collection duration)

    Summarized descriptively

  6. Levels of 5-hydroxyindoleacetic acid (5-HIAA) (urine test or blood test) before treatment with octreotide, during treatment with octreotide and during treatment with lanreotide, as available

    Time frame: 4 months (data collection duration)

    Summarized descriptively

  7. Levels of Chromogranin A (CgA) before treatment with octreotide, during treatment with octreotide and during treatment with lanreotide, as available

    Time frame: 4 months (data collection duration)

    Summarized descriptively

  8. Severity of symptoms (i.e., flushing, diarrhea, dyspnea, abdominal pain, edema, nausea) before treatment with octreotide, during treatment with octreotide, and during treatment with lanreotide, as available

    Time frame: 4 months (data collection duration)

    Proportion of patients reporting each symptom

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Multicenter, Retrospective, Medical Record Review Of The Effectiveness Of Lanreotide Following Treatment With Octreotide In Patients With Neuroendocrine Tumors

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2017
Registry last updated
Jun 2, 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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