NCT01444209终止2 期
Interstitial Radioactive Iodine Implants for the Treatment of Pan-invasive Pituitary Macroadenomas
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Partial Response (Reduction in 30% of Tumor Volume) or Greater Response Within 12 Months From the Implant Procedure.
研究概览
简要总结
This study is a single arm Phase II pilot trial. Patients enrolled on the trial will undergo implantation of high activity iodine-125 seeds into their pituitary adenoma. The tumor response to treatment will be monitored as well as change in visual fields, associated adverse effects, progression free survival and patient reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological or radiographic diagnosis of a pan-invasive pituitary macroadenoma
- •Pan-invasive for the purposes of the protocol will be defined as meeting each of the following 2 major criteria: (1). tumor volume greater than 20 cc at enrollment, and (2). suprasellar extension. In addition, a pan-invasive tumor must meet any one of the following 3 minor criteria, a) unresectable tumor invasion into a cavernous sinus, b) bone or bone marrow invasion into the clivus or temporal bones, or c) tumor extension in any direction unlikely to be completely removed by specifically a transphenoidal surgical approach.
- •Patients who meet the two major criteria above (1 and 2) and are medically inoperable for tumor resection (due to confounding co-existing medical problems) are eligible without meeting any of the three minor criteria (a, b, or c).
- •Patients should be immediately threatened for vision loss or other significant neurological impairment directly related to tumor mass effect. As such, all patients enrolled would likely benefit from tumor response (shrinkage).
- •Patients must have visible tumor on imaging studies (MRI or CT)
- •The patient's Zubrod performance status must be 0-
- •Patients must be at least 18 years of age.
- •Mandatory Imaging Studies: Must be done 45 or fewer days prior to :
- •MRI or CT scan of the brain including the entire skull base and all areas of tumor extension
排除标准
- •Patients who are unable to undergo general anesthesia
- •Patients who are unable to undergo placement of a stereotactic head frame
- •Patients who are unable to provide informed consent
- •Patients who are pregnant or nursing
- •Patients with severe kidney dysfunction
- •Patients who have contraindications to MRI, such as implanted pacemaker device
- •Patients with diagnosis of pituitary carcinoma
研究组 & 干预措施
Radiation Therapy
Experimental
Interstitial Radioactive Iodine Implants
干预措施: Iodine Implants (Radiation)
结局指标
主要结局
Partial Response (Reduction in 30% of Tumor Volume) or Greater Response Within 12 Months From the Implant Procedure.
时间窗: 12 months
次要结局
- Progression Free Survival(5 years)
- The Cost-utility of the Treatment Arm (in Terms of the Primary Outcome) in Comparison With Other Widely Accepted Cancer and Non-cancer Therapies(5 years)
- Potential Toxicities Associated With Interstitial Seed Placement(5 years)
- Change of the Patient's Humphrey Visual Field Testing(5 years)
- The Effect of the Treatment on Quality of Life Evaluations (Patient Reported Outcomes)(5 years)
研究者
Robert Timmerman
Professor
University of Texas Southwestern Medical Center
研究点 (1)
Loading locations...
相似试验
已完成
不适用
TELAMON P™ Implant/INFUSE® Bone Graft/CD HORIZON® Spinal System Pilot StudyDegenerative Disc DiseaseNCT01491516Medtronic Spinal and Biologics30
已完成
不适用
Intraoperative Radiotherapy After Local Recurrence in Breast CancerBreast CarcinomaNCT02386371Institut du Cancer de Montpellier - Val d'Aurelle66
招募中
1 期
Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic LeukemiaB-cell NHLCLLNCT05869279Fondazione Matilde Tettamanti Menotti De Marchi Onlus29
招募中
不适用
Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent SarcomaMetastatic SarcomaRecurrent SarcomaResectable SarcomaNCT04199026M.D. Anderson Cancer Center20
已完成
2 期
Phase II study of Intraoperative radiation therapy in early breast cancerearly breast cancerJPRN-UMIN000003578Aichi Cancer Center Hospital142