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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Surgical Debulking of Pituitary Adenomas

NCTNCT01371643 (opens ClinicalTrials.gov in a new tab)Other idR11104
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Overview

Status
Completed
Phase
Phase 4
Enrollment
41 participants (actual)
Sponsor
NYU Langone Health · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Apr 2004
Primary completion
Jul 2010
Completion
Dec 2011
First posted
13 Jun 2011 (estimated)
Last update posted
29 Aug 2016 (estimated)
Conditions
Pituitary Adenoma

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042006200820102012
  1. Ph 4

    Surgical Debulking of Pituitary Adenomas

    NCT01371643

    Apr 2004 to Dec 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Octreotide LARDrug
  • transsphenoidal surgeryProcedure

Arms2

  • Active comparator

    Medical treatment by Octreotide LAR

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

  • Active comparator

    Surgical debulking followed by Octreotide LAR

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

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · 3 months

    Registry description

    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.

  2. Percentage of Responders (All Treatments)

    Time frame · 3 months

    Registry description

    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.

Secondary outcomes(1)

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

    Time frame · 3 months

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 3 months

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

GroupValue (percentage of participants)
Medical Treatment by Octreotide LAR6.7
Surgical Debulking Followed by Octreotide LAR50
Primary outcomeNumber· 3 months

Percentage of Responders (All Treatments)

GroupValue (percentage of participants)
Medical Treatment by Octreotide LAR6.7
Surgical Debulking Followed by Octreotide LAR76.9
Secondary and other outcome results(1)
Secondary outcomeNumber· 3 months

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

GroupValue (percentage of participants)
Medical Treatment by Octreotide LAR6.7
Surgical Debulking Followed by Octreotide LAR53.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Medical Treatment by Octreotide LARMedical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery Octreotide LAR–0 / 155 / 15
Surgical Debulking Followed by Octreotide LARSurgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured Octreotide LAR transsphenoidal surgery–1 / 2612 / 26

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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