Phase 4
Completed N=41
Surgical Debulking of Pituitary Adenomas
Source: ClinicalTrials.gov NCT01371643 ↗Enrolled (actual)
41
Serious AEs
2.4%
Results posted
Jul 2016
Primary outcomePrimary: Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2) — 6.7; 50 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2) |
6.7; 50 | — |
| PRIMARY Percentage of Responders (All Treatments) |
6.7; 76.9 | — |
| SECONDARY Percentage of Responders (Only Including Surgical Failures in Arm 2) |
6.7; 53.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT01371643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.