Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis

What Was Tested

The trial (phase 3) is built around Lanreotide.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 80 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: Digestive obstruction located in the upper part of the gastro-intestinal tract. Digestive obstruction of malignant origin. Peritoneal carcinomatosis confirmed by a CT Scan. At least two vomiting episodes per day or a presence of a nasogastric suction tube.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: specific anticancer therapy within the previous 15 days; signs of bowel perforation; somatostatin or any analogue as treatment of the bowel obstruction.

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 Lanreotide and who got the comparison, which limits bias.

The Lanreotide group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant and investigator.

It started in 2003-09 with completion listed for 2008-10.

It ran at 53 sites in France (48), Belgium (4) and Netherlands (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of responder patients (patient with 1 or less vomiting episode per day during at least 3 consecutive days or in whom nasogastric tube (NGT) has been removed during at least three consecutive days without vomiting recurrence) (time frame: On day 7 (plus 1 day at the latest) after the first injection).

It also tracked 6 secondary outcomes, for example Number of daily vomiting episodes or measurement of the daily drainage by NGT, Number of days with no vomiting episodes, Number of daily nausea episodes, Intensity of abdominal pain, Well-being and Symptom relief duration.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lanreotide in 80 people.

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

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