Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut

What Was Tested

The trial (phase 3) is built around Octreotide.

Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut.

It had two arms (groups): Octreotide LAR (Long Acting Release) (experimental) and Placebo (placebo comparator).

Placebo - Sodium chloride intramuscularly every 28 days.

The registry classes the interventions as drug.

Who Took Part

The registry lists 85 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: Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable or metastasized well-differentiated neuroendocrine tumor of the midgut. Curative surgery impossible. Two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI). Age ≥ 18. Karnofsky-index \> 60.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: hypersensitivity to octreotide; poorly differentiated or small cell neuroendocrine tumors; primary tumor outside of the midgut.

How the Study Was Run

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

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

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, care provider, investigator and outcomes assessor.

It started in 2001-09 with completion listed for 2008-06.

It ran at 10 sites in Germany (10).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) (time frame: Up to 7 years).

It also tracked 5 secondary outcomes, for example Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals, Biochemical Response at 3 Month Intervals, Symptom Control at 3 Month Intervals, Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study and Survival.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 85 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.