Acromegaly Due to Pituitary Adenoma Clinical Trial
Official title:
Multicenter Evaluation of the Effect of Upfront Radiosurgery on Residual Growth Hormone-secreting Pituitary Adenoma From an Endocrinological Point of View (MERGE Study): a Randomized, Phase 3 Trial
In this study, the investigators hypothesize that upfront gamma knife radiosurgery with drug therapy is superior in the treatment of growth hormone-secreting pituitary tumors after primary surgical treatment compared with the drug therapy alone. This study can provide useful clinical information in the treatment of patients with acromegaly.
Acromegaly is often caused by growth hormone (GH)-secreting pituitary adenoma and causes
anatomic changes in the body and various metabolic disorders caused by increased GH and
insulin-like growth factor-1 (IGF1). Surgical treatment of pituitary tumors is the preferred
standard of care, but only 40-70% of patients can be treated with surgical treatment alone.
In many cases, complete resection of the tumor is not possible and the hormone imbalance
persists after surgery. After surgical treatment, several additional treatments are needed to
prevent hypersecretion of GH and to normalize blood levels of IGF-1.
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. However, according to the recent guideline, the endocrine remission rate
obtained from post-operative drug therapy is only 17-35%. 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. There is a need for therapeutic
intervention to reduce the dose and duration of therapy, to prevent tumor recurrence, and to
achieve rapid endocrinologic remission.
Stereotactic radiosurgery (SRS), such as gamma knife radiosurgery, has been actively
introduced worldwide to control residual pituitary tumors and has been applied to more than
200 cases of intractable acromegaly. The effect of SRS on endocrine remission in patients who
did not receive endocrine therapy was confirmed in the literature. In a study of 136 patients
who underwent preoperative radiotherapy followed by more than 5 years of follow-up, 65.4% of
patients reported endocrine remission. According to the recently published meta-analysis, SRS
showed 93-100% tumor growth control and size reduction within 5 to 10 years after surgery.
The endocrinologic remission rate was reported to be 40-60% at 5 years.
To date, SRS has been recommended for the treatment of growth hormone - secreting pituitary
tumors in cases where surgical removal is not feasible from the beginning or if drug
treatment fails after surgical removal. Only the retrospective study of SRS was performed and
no prospective study was conducted at all. However, many institutions already prefer
preemptive SRS treatment for residual tumor after surgery and have been practiced in many
patients. Therefore, prospective clinical trials are needed to establish the basis for
upfront SRS and establish the treatment strategy for patients who do not have endocrine
remission after surgical treatment of GH secretory pituitary tumor.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03807076 -
Modulating the GIP System in Patients With Acromegaly Due to a Pituitary Tumor
|
N/A |