A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET)

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Lanreotide.

It had two arms (groups): lanreotide (experimental) and placebo (placebo comparator).

In this arm, patients will receive placebo every 28 days until disease progression.

The registry classes the interventions as drug.

More on the Plan

Depending on the phase II results, the study may be continued into phase III.

The treatment and follow-up of patients will be the same in phase II and phase III.

After the first-line treatment, patients will be randomly assigned with a 1:1 ratio to receive either lanreotide or placebo.

The study treatment should be initiated within 6 weeks following the confirmation date of stable disease or objective response.

Who Took Part

Enrollment: 53 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: Progressive before first-line treatment. Histologically confirmed (either on primary tumour or metastases). Pathological diagnosis validated by the NET consulting pathologist. Documented stable disease or objective response after first-line treatment, within 4 weeks (28 days) prior to randomisation. Non-functional tumour or gastrinoma controlled by PPIs.

The full record lists 11 inclusion and 11 exclusion criteria; among the exclusions: if primary resected, bone metastasis exclusively; pre-treatment by somatostatin long-acting analogue; total bilirubin ≥ 60 µmol/l.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Lanreotide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Lanreotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2015-01 with completion listed for 2020-01.

It ran at 24 sites in France (19), Germany (2), United Kingdom (2) and Belgium (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Proportion of Patients Alive and Progression-free at 6 Months (time frame: 6 months).

It also tracked 2 secondary outcomes, for example Progression-Free Survival and Overall Survival.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Lanreotide in 53 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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