SURGICAL DEBULKING PLUS OCTREOTIDE VERSUS OCTREOTIDE ALONE IN ACROMEGALY

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multicenter, investigator-initiated randomized study of long-acting octreotide (Sandostatin) alone vs. surgical debulking plus octreotide in acromegaly to determine if surgical debulking improves treatment effect. Data on currently available treatments (surgery, somatostatin analogs) are often difficult to compare, and no randomized trials have been completed. Subjects will be randomized to Arm A or B (1:2 ratio). Arm A begins with medical treatment alone: Patients are followed for 3 doses on Sandostatin. Arm B begins with surgical treatment alone. If after surgery the patient is not cured, the patient will go on Sandostatin for 3 doses (over 3 months). Endpoints are functional measures (IGF-I) and tumor size (MRI). The study may lead to a change in the initial management of patients, because surgery of macroadenomas of this sort is not initial treatment.