OTHER
Data collection
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.
Status
Completed
Phase
Not applicable
Enrollment
93
Locations
8
Results
Not posted
Publications
0
Study summary
The purpose of this study is to understand how people with neuroendocrine tumors respond to treatment with lanreotide after having received treatment with octreotide.
Interventions
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.
Timeline
First posted
Apr 13, 2017
Study start
Apr 4, 2017
Primary completion
Nov 2, 2017
Study completion
Nov 2, 2017
Results posted
Not reported
Registry updated
Jun 2, 2020
Outcomes
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)
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.
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.
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).
Severity of Adverse Events
Time frame · 4 months (data collection duration)
Summarized separately during treatment with octreotide and during treatment with lanreotide, as available
Reasons for switching from octreotide to lanreotide
Time frame · 4 months (data collection duration)
Summarized descriptively
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
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
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
Eligibility
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)
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Moffitt Cancer Center
Tampa, Florida, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
National Transitional Research
East Setauket, New York, United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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