A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours

What Was Tested

This registered phase 3 trial tested Octreotide.

It had two arms (groups): 177Lu-DOTA0-Tyr3-Octreotate (experimental) and Octreotide LAR (active comparator).

The registry classes the interventions as drug.

More on the Plan

After the screening period, participants who signed the ICF and were eligible for the study in accordance with the entry criteria were randomly assigned to treatment either Lutathera or Octreotide LAR.

Objective tumor assessment in both groups was performed every 12+/-1 weeks from the randomization date according to RECIST Criteria until progression was centrally confirmed: 1.

Any participants with progressive disease (confirmed by central review of CT/MRI scans) ceased the treatment/assessment period and proceeded to the long-term follow-up period for evaluation of survival and long-term safety. 2.

Once the Primary End-Point was reached: 1.

Who Took Part

The registry lists 231 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: Patients ≥18 years of age. Karnofsky Performance Score (KPS)\>=60. Presence of at least 1 measurable site of disease.

The full record lists 10 inclusion and 21 exclusion criteria; among the exclusions: total bilirubin \>3 x uln; pregnancy or lactation; peptide receptor radionuclide therapy (prrt) at any time prior to randomization in the study.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2012-09-06 with completion listed for 2015-07-31.

It ran at 39 sites in United States (13), France (6), Italy (6), United Kingdom (5), Germany (4) and Portugal (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Progression Free Survival (PFS).

It also tracked 8 secondary outcomes, for example Objective Response Rate (ORR), Overall Survival (OS), Rate of Overall Survival (OS), Time to Tumour Progression (TTP), Duration of Response (DoR) and Number of Participants With Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 231 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.