Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

What Was Tested

The trial (phase 3) is built around Octreotide.

It had two arms (groups): Octreotide+ Everolimus (experimental) and Octreotide+ Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 429 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: Advanced (unresectable or metastatic) carcinoid tumor. Confirmed low-grade or intermediate-grade neuroendocrine carcinoma. Documented progression of disease within 12 months prior to randomization. Measurable disease determined by triphasic computer tomography (CT) scan or magnetic resonance imaging (MRI).

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoma, or small cell carcinoma; hepatic artery embolization within the last 6 months or cryoablation of hepatic metastasis within 2 months of enrollment; previous treatment with mammalian target of rapamycin (mtor) inhibitors (sirolimus, temsirolimus, everolimus).

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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

As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2006-12 with completion listed for 2010-04.

It ran at 70 sites in United States (38), France (7), Italy (5), Canada (4), Australia (3) and Czechia (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review.

It also tracked 6 secondary outcomes, for example Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST), Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level, Overall Survival Using Kaplan-Meier Methodology and Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 429 people.

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

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