Status:
UNKNOWN
Multicenter Evaluation of the Effect of Upfront Radiosurgery on Residual Growth Hormone-secreting Pituitary Adenoma
Lead Sponsor:
Samsung Medical Center
Conditions:
Acromegaly Due to Pituitary Adenoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 tr...
Detailed Description
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 fac...
Eligibility Criteria
Inclusion
- 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
- random growth hormone level \< 2.5 ug/L
- normalization of age-matched insulin growth factor-1 level
Exclusion
- 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
- disability to clinic visit due to postoperative complications
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03439709
Start Date
March 1 2018
End Date
December 31 2022
Last Update
March 1 2018
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351