Multicenter Evaluation of the Effect of Upfront Radiosurgery on Residual Growth Hormone-secreting Pituitary Adenoma

What Was Tested

The trial (phase 3) is built around Lanreotide.

This study can provide useful clinical information in the treatment of patients with acromegaly.

It had two arms (groups): intervention (experimental) and control (active comparator).

The registry classes the interventions as drug and radiation.

More on the Plan

In many cases, complete resection of the tumor is not possible and the hormone imbalance persists after surgery.

As first-line treatment after surgical resection, there are typically drug therapy and radiation therapy.

The most common used drugs are octreotide and lanreotide, which are growth hormone analogues.

Although clinical trials are underway for new drugs, the burden of expensive drug costs, recurrence during drug withdrawal, and drug side effects remains major drawbacks.

Who Took Part

The registry lists 90 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Among patients with acromegaly due to growth hormone secreting pituitary adenoma who underwent primary surgical resection, patients who fail to achieve endocrinologic remission at 3 months after surgery. On brain MRI scan at 3months after surgery, residual tumor is confirmed by clinicians. The definition of endocrinologic remission. Normalization of age-matched insulin growth factor-1 level.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: patients with contraindication of stereotactic radiosurgery; e.g. pregnancy or planning pregnancy, or claustrophobia; recurrent pituitary adenoma; limited life expectancy due to systemic disease; e.g. malignant tumor, genetic disease, and terminal stage of renal or hepatic failure.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Everyone knew when Lanreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-03-01 with completion listed for 2022-06-30.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: endocrinologic remission (time frame: at 2 year after initial enrollment).

It also tracked 4 secondary outcomes, for example tumor size, side effect and performance status.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lanreotide in 90 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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