Surgical Debulking of Pituitary Adenomas

NCT01371643 | Completed Phase 4 Results

• 1 other identifier: R11104
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, multicenter trial with stratification 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.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.

Conditions

Pituitary Adenoma

Outcome Measures

Primary Outcomes (2)

• Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2)

  Nadir growth hormone \<1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.

  3 months

• Percentage of Responders (All Treatments)

  Nadir growth hormone \<1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.

  3 months

Secondary Outcomes (1)

• Percentage of Responders (Only Including Surgical Failures in Arm 2)

  3 months

Study Arms (2)

Medical treatment by Octreotide LAR

ACTIVE COMPARATOR

Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery

Drug: Octreotide LAR

Surgical debulking followed by Octreotide LAR

ACTIVE COMPARATOR

Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured

Drug: Octreotide LAR; Procedure: transsphenoidal surgery

Interventions

Octreotide LAR DRUG

Medical treatment by Octreotide LAR; Surgical debulking followed by Octreotide LAR

transsphenoidal surgery PROCEDURE

Surgical debulking followed by Octreotide LAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; 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

Results Point of Contact

• Title: David Kleinberg
• Organization: NYU Langone Medical Center

David.Kleinberg@nyumc.org

212 263 6772

Study Officials

• David M Kleinberg, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 13, 2011
• Study Start: April 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2011
• Last Updated: August 29, 2016
• Results First Posted: July 22, 2016

Record last verified: 2016-07

Locations

US (1)