Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis

What Was Tested

The trial (phase 3) is built around Octreotide for endometriosis.

It had two arms (groups): octreotide + radiation (experimental) and placebo + radiation (active comparator).

Patients receive short-acting octreotide subcutaneously (SC) on day 1 and long-acting octreotide intramuscularly (IM) on days 2 and 29. Treatment continues in the absence of unacceptable toxicity or the development of severe diarrhea. Patients complete a bowel function questionnaire at baseline, weekly during radiotherapy, and then weekly for 4 weeks and at 1 and 2 years after completion of radiotherapy. Patients are followed weekly for 4 weeks and then at 1 and 2 years.

Patients receive placebo SC on day 1 and IM on days 2 and 29. Treatment continues in the absence of unacceptable toxicity or the development of severe diarrhea. Patients complete a bowel function questionnaire at baseline, weekly during radiotherapy, and then weekly for 4 weeks and at 1 and 2 years after completion of radiotherapy. Patients are followed weekly for 4 weeks and then at 1 and 2 years.

The registry classes the interventions as drug, other and radiation.

More on the Plan

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.

In both arms, treatment continues in the absence of unacceptable toxicity or the development of severe diarrhea.

Patients complete a bowel function questionnaire at baseline, weekly during radiotherapy, and then weekly for 4 weeks and at 1 and 2 years after completion of radiotherapy.

Patients are followed weekly for 4 weeks and then at 1 and 2 years.

Who Took Part

130 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: Portions of rectum may have special blocking depending on disease site. No planned split-course radiotherapy. No planned interstitial brachytherapy prior to completion of external-beam radiotherapy. Planned intracavitary radiotherapy allowed. No planned cytotoxic chemotherapy agents concurrently with radiotherapy except fluorouracil with or without leucovorin calcium or cisplatin.

The full record lists 28 inclusion and 0 exclusion criteria.

How the Study Was Run

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

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the endometriosis participants and researchers unaware of who received Octreotide.

Those kept unaware of assignments: participant and investigator.

It started in 2002-04 with completion listed for 2006-07.

Its stated primary purpose is supportive care.

What Was Measured

It also tracked 3 secondary outcomes, for example Toxicity as assessed by NCI CTC version 2.0 weekly during pelvic radiotherapy.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 130 people with endometriosis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, Endometriosis research.