NCT01371643 · REGISTRY CONDITION SEARCH

Surgical Debulking of Pituitary Adenomas

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE4
Status at capture: COMPLETED
Registry last update: 2016-08-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Percentage of Responders (All Treatments)

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
intervention Names
Drug: Octreotide LAR
label
Medical treatment by Octreotide LAR
type
ACTIVE_COMPARATOR
description
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
intervention Names
Drug: Octreotide LAR
Procedure: transsphenoidal surgery
label
Surgical debulking followed by Octreotide LAR
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Medical treatment by Octreotide LAR
Surgical debulking followed by Octreotide LAR
name
Octreotide LAR
type
DRUG
arm Group Labels
Surgical debulking followed by Octreotide LAR
name
transsphenoidal surgery
type
PROCEDURE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

Enrollment

count: 41
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2)
time Frame
3 months
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.
measure
Percentage of Responders (All Treatments)
time Frame
3 months

secondary Outcomes

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.
measure
Percentage of Responders (Only Including Surgical Failures in Arm 2)
time Frame
3 months

Full study description

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.
detailed Description: 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.

Source references

Source notices and limitations

Discovery and provenance

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ctgov-registry-1336d216cbd1bbff780dac70
edge id
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requested nct id
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primary nct id
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source kind
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source record id
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end
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exact text
NCT01371643
start
0
offset unit
unicode_code_points
query cond
Pituitary Tumors
query disease state id
ds-pituitary-tumors
source file
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source file sha256
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source json pointer
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source kind
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source record id
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source string basis
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Pituitary+Tumors&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice