Clinical trial NCT03112694: Switching From Octreotide to Lanreotide - A Look Back at Patients With Neuroendocrine Tumors
Official title: A Multicenter, Retrospective, Medical Record Review Of The Effectiveness Of Lanreotide Following Treatment With Octreotide In Patients With Neuroendocrine Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2017-04-13
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitals and clinics

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Response to treatment
timeFrame: 4 months (data collection duration)
Secondary outcomes:
measure: Progression-free survival, after treatment with octreotide
timeFrame: 4 months (data collection duration)
measure: Duration of response to lanreotide, after treatment with octreotide
timeFrame: 4 months (data collection duration)
measure: Duration of treatment with octreotide and duration of treatment with lanreotide
timeFrame: 4 months (data collection duration)
measure: Severity of Adverse Events
timeFrame: 4 months (data collection duration)
measure: Reasons for switching from octreotide to lanreotide
timeFrame: 4 months (data collection duration)
measure: 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
timeFrame: 4 months (data collection duration)
measure: Levels of Chromogranin A (CgA) before treatment with octreotide, during treatment with octreotide and during treatment with lanreotide, as available
timeFrame: 4 months (data collection duration)
measure: 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
timeFrame: 4 months (data collection duration)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: East Setauket
country: United States
facility: National Transitional Research
state: New York
city: Pittsburgh
country: United States
facility: Allegheny Cancer Center
state: Pennsylvania
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: