Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group

What Was Tested

This randomized controlled trial paper looks at Octreotide.

Somatostatin analogs are indicated for symptom control in patients with gastroenteropancreatic neuroendocrine tumors (NETs).

The ability of somatostatin analogs to control the growth of well-differentiated metastatic NETs is a matter of debate.

The researchers performed a placebo-controlled, double-blind, phase IIIB study in patients with well-differentiated metastatic midgut NETs.

Who Took Part

The study group was 85 patients.

PubMed tags the participants as both men and women.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

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

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

The comparison arm used a placebo, so changes seen with Octreotide could be set against what happens without it.

Secondary end points were survival time and tumor response.

What Was Measured

Topics PubMed links to this paper include Abdominal Pain, Antineoplastic Agents, Hormonal, Diarrhea, Intestinal Neoplasms, Karnofsky Performance Status, Ki-67 Antigen and Liver Neoplasms.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Octreotide in 85 patients.

The abstract goes on to report its results in about 8 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2009 (Journal of clinical oncology : official journal of the American Society of Clinical Oncology), a journal based in United States.

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