Surgical Debulking of Pituitary Adenomas

Pituitary Adenoma Clinical Trial

Official title:

Does Surgical Debulking Of Pituitary Adenomas Improve Responsiveness To Octreotide LAR In The Treatment Of Acromegaly: An Investigator-Initiated Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371643
• Other study ID #: R11104
• Status: Completed
• Phase: Phase 4
• First received: June 9, 2011
• Last updated: October 16, 2012
• Start date: April 2004
• Est. completion date: December 2011

Study information

• Verified date: October 2012
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Purpose:

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.

Background:

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.

Study Design:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Carry a diagnosis of de novo acromegaly with an elevated age and sex matched IGF-I and GH >1ng/ml at all time points during OGTT

• Have a pituitary macroadenoma

• Have clinical changes consistent with acromegaly

• Have a single random serum hGH of 12.5 ng/ml or greater

• Both the endocrinologist and surgeon must agree that the patient's health would not be compromised by a three-month period during which time Octreotide LAR is administered.

• Patients currently on dopamine agonist who agree to discontinue medication (2-6 week washout required)

Exclusion Criteria:

• Pregnant or breastfeeding

• Documented loss of vision due to pituitary tumor

• Prior treatment for acromegaly other than dopamine agonists

• Inability to complete the protocol

• Intolerance to octreotide

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Drug:
• Octreotide LAR

Procedure:
• transsphenoidal surgery

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does surgery improve response rate to Octreotide LAR treatment?	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.	3 months	No