Surgical Debulking of Pituitary Adenomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David L. Kleinberg, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01371643
First received: June 9, 2011
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Pituitary Adenoma
Drug: Octreotide LAR
Procedure: transsphenoidal surgery
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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.


Enrollment: 41
Study Start Date: April 2004
Study Completion Date: December 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371643

Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: David M Kleinberg, MD NYU School of Medicine
  More Information

No publications provided

Responsible Party: David L. Kleinberg, Professor, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01371643     History of Changes
Other Study ID Numbers: R11104
Study First Received: June 9, 2011
Last Updated: October 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenoma
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Pituitary Diseases
Endocrine System Diseases
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 28, 2014