Clinical trial · Interventional
Surgical Debulking of Pituitary Adenomas
Does Surgical Debulking Of Pituitary Adenomas Improve Responsiveness To Octreotide LAR In The Treatment Of Acromegaly: An Investigator-Initiated Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Octreotide LAR | Drug | — | UNRESOLVED |
| transsphenoidal surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Medical treatment by Octreotide LAR
- description
- Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
- interventionNames
- Drug: Octreotide LAR
- type
- ACTIVE_COMPARATOR
- label
- Surgical debulking followed by Octreotide LAR
- description
- Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
- interventionNames
- Drug: Octreotide LAR
- Procedure: transsphenoidal surgery
Primary outcomes (2)
- measure
- Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available