Current partner codePEPTIDESDE
NCT03112694·Not applicable·OBSERVATIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

93

Locations

8

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Apr 13, 2017

  2. Study start

    Apr 4, 2017

  3. Primary completion

    Nov 2, 2017

  4. Study completion

    Nov 2, 2017

  5. Results posted

    Not reported

  6. Registry updated

    Jun 2, 2020

Outcomes

What the study measures.

Primary 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)

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

8 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Lanreotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.