Surgical Debulking of Pituitary Adenomas
The primary objective of this trial will be to determine whether surgery (debulking of pituitary adenomas) improves the response of patients with acromegaly to treatment with Octreotide LAR, when compared to Octreotide LAR therapy alone.
The current goal of treatment for people with acromegaly is normalization of both growth hormone (GH) and insulin-like-growth-factor-1 (IGF-1) levels. Normalization of GH and IGF-1 levels attenuates the morbidity (hypertension, cardiovascular disease, sleep apnea, increased cancer risk, arthritis) and increased mortality associated with persistent GH and IGF-1 elevation. The optimal approach to achieving these goals in patients with pituitary macroadenomas remains controversial. Available treatment modalities include transsphenoidal hypophysectomy, medical therapy (somatostatin analogues and/or dopaminergic agonists), radiotherapy, or a combination or these interventions. No randomized trials have been conducted to investigate whether surgical debulking of pituitary macroadenomas enhances the efficacy of medical therapy. This study is designed to rigorously investigate whether surgical debulking increases the efficacy of a long-acting depot somatostatin preparation, Sandostatin LAR, so that evidence-based optimal care may be offered to patients with acromegaly.
This is a randomized, multicenter trial. A total of 69 patients from 6 or more centers will be enrolled and complete the study. Stratification will be done by a single radiologist at the coordinating center (NYU), and patients with comparable disease will be randomized to Sandostatin LAR treatment administered 1 time per month by IM injection for 3 months before (Arm A) or, for non-cured patients, after (Arm B) surgery. All patients will undergo transsphenoidal hypophysectomy. The impact of surgical debulking on responsiveness to Sandostatin LAR will be evaluated.
Drug: Octreotide LAR
Procedure: transsphenoidal surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Does Surgical Debulking Of Pituitary Adenomas Improve Responsiveness To Octreotide LAR In The Treatment Of Acromegaly: An Investigator-Initiated Study|
- Does surgery improve response rate to Octreotide LAR treatment? [ Time Frame: 3 months ] [ Designated as safety issue: No ]To determine whether surgery (debulking of pituitary tumors) improves the response rate to Octreotide LAR treatment in patients with acromegaly, when compared to Octreotide LAR therapy alone.
|Study Start Date:||April 2004|
|Study Completion Date:||December 2011|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Medical treatment by Octreotide LAR
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
|Drug: Octreotide LAR|
Active Comparator: Surgical debulking followed by Octreotide LAR
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
|Procedure: transsphenoidal surgery|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371643
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||David M Kleinberg, MD||NYU School of Medicine|