Does Surgical Debulking Of Pituitary Adenomas Improve Responsiveness To Octreotide LAR In The Treatment Of Acromegaly: An Investigator-Initiated Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Medical treatment by Octreotide LAR
Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
干预措施: Octreotide LAR (Drug)
Surgical debulking followed by Octreotide LAR
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
干预措施: Octreotide LAR (Drug)
Surgical debulking followed by Octreotide LAR
Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
干预措施: transsphenoidal surgery (Procedure)
结局指标
主要结局
Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2)
时间窗: 3 months
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.
Percentage of Responders (All Treatments)
时间窗: 3 months
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.
次要结局
- Percentage of Responders (Only Including Surgical Failures in Arm 2)(3 months)