Circulating Tumour Cells in Somatuline Autogel Treated NeuroEndocrine Tumours Patients

What Was Tested

In this phase 4 trial, researchers set out to test Lanreotide.

It had 1 arm (groups): Somatuline Autogel® (experimental).

Somatuline Autogel® to treat Functioning Midgut NeuroEndocrine Tumours (NET).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 50 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Provision of written informed consent prior to any study related procedures. Patients (either sex) must be 18 years or older. Patients must be suffering from symptoms of diarrhoea and/or flushing at the time of study enrolment. Patients must have a documented diagnosis of a functioning midgut NET. The clinically appropriate treatment for the patient must be therapy with a somatostatin analogue.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: if the patient is at risk of pregnancy or is breast feeding, unless treatment with somatuline autogel is clearly needed (as determined by the clinician); the patient has received interferon, chemotherapy, chemoembolisation or radionuclide therapy within 3 months prior to study entry; the patient has a history of hypersensitivity to drugs with a similar chemical structure.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Lanreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-05 with completion listed for 2017-06.

It ran at 14 sites in United Kingdom (14).

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Assessment of Clinical Symptomatic Response (time frame: From baseline up to Week 53). Percentage of Subjects With Time Point Responses According to Response Evaluation Criteria in Solid Tumours (RECIST) Assessments at Weeks 25 and 53 (time frame: Week 25 and Week 53).

It also tracked 5 secondary outcomes, for example Mean Change From Baseline in Number of Episodes of Diarrhoea and Flushing, Mode Symptom Severity of Episodes of Flushing, Quality of Life (QoL) Questionnaire: European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire (QLQ)-C30, QoL Questionnaire: EORTC QLQ-G.I.NET21 and Percentage of Subjects Alive and Progression Free at One Year.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Lanreotide in 50 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Lanreotide compound page, all human trials.