Prospective Study Of Patients With Recurrent Or Incomplete Excised Benign Intercranial Meningiomas For The Evaluation Of Treatment Result With Combined Proton And Photon Irradiation To Doses 55.8 Or 63.0 CGE
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to determine the best radiation dose for participants with meningioma that has grown back after previous surgery, or which the surgeon has been unable to remove completely. This research study is designed to determine whether a higher dose of radiation will decrease the likelihood that the tumor will grow back, compared to the probability of re-growth that occurs after standard radiation doses.
详细描述
- After initial interview and physical examination, an immobilization device (head mask, neck support, back support, etc.) will be made for the participant. A treatment planning CT will be performed and a radiation treatment plan will be based on this CT scan.
- The radiation dose will usually be given once a day, five days per week. The radiation treatment will take between 7 and 8 1/2 weeks, including treatment planning.
- Treatment doses will vary, and the dose each participant will receive will be made on the basis of random assignment. Participants will either receive the usual dose of 55.8 CGE in 31 treatments or 1.8 CGE, or 63 CGE in 35 treatments of 1.8 CGE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age 18 or over
- •Histological documentation of benign meningioma
- •Documentation by imaging studies (CT and/ or MRI) or residual or recurrent intracranial tumor
- •Karnofsky performance status of ≥ 70
- •Study specific informed consent
排除标准
- •Malignant meningiomas
- •Prior cranial irradiation, except treatment of localized skin cancer of the face or scalp
- •Patients having a concurrent primary cancer (except skin)
- •Patients having another cancer controlled < 3 years
- •Pregnant patients
结局指标
主要结局
Progression Free Survival
时间窗: 5, 10, 15 years
The number of participants surviving at the given time point. Progression free survival (PFS) is measured from the starting date of radiation therapy and analyzed by intention to treat. PFS is measured until the earlier, date of death or development of radiologic progression, and is otherwise censored at the last follow-up for progression-free patients still alive.
次要结局
- Acute Toxicities(90 Days)
- Late Toxicities(5 Years)
- Local Failure Rate(15 Years)
研究者
Helen A. Shih, MD
Prinicipal Investigator
Massachusetts General Hospital