Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors

What Was Tested

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

PURPOSE: This phase II trial is studying how well internal radiation therapy works in treating patients with liver metastases from neuroendocrine tumors.

It had 1 arm (groups): Sir-Spheres (experimental).

The registry classes the interventions as drug and radiation.

More on the Plan

OBJECTIVES: Primary * Determine tumor response to selective internal radiation therapy with yttrium Y 90 resin microspheres (Sir-Spheres®) in patients with progressive liver metastases from neuroendocrine tumors.

Secondary * Determine the toxicity of this treatment in these patients. * Determine the symptomatic relief of patients treated with this regimen. * Determine the health-related quality of life of patients receiving this treatment.

OUTLINE: Patients have an catheter placed into the hepatic artery percutaneously through the groin and then undergo selective internal radiation therapy with yttrium Y 90 resin microspheres (Sir-Spheres®) via the catheter on day 1.

Patients also receive octreotide acetate IV 1 hour prior to, during, and 2 hours after Sir-Spheres® injection.

Who Took Part

10 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: Pathologically confirmed neuroendocrine tumor metastatic to the liver. Well-differentiated or moderately well-differentiated neuroendocrine tumors. Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral CT scan. Symptomatic disease, meeting one of the following criteria:. Evidence of radiographic progression with either of the following manifestations:.

The full record lists 31 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Octreotide study did not mask who received what.

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

It started in 2003-12 with completion listed for 2006-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Tumor response.

It also tracked 3 secondary outcomes, for example Toxicity as measured by CTC v3.0, Symptomatic relief as measured by Carcinoid Symptom Scale, SF-36 Pain scale, and SF-36 physical component summary and Patient report of Health-related quality of life (HRQOL).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 10 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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