Feasibility and Phase II Study Using Proton Radiation For WHO Grade I-III Meningiomas and Hemangiopericytomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Feasibility and Safety
研究概览
简要总结
This is a Feasibility/Phase II study for patients with a diagnosis of WHO Grade I - III Meningioma & Hemangiopericytoma brain cancer to be given standard dose Proton radiotherapy. The study will be performed in two phases: first, feasibility with an enrollment of 12 patients and then Phase Page 8 of 20 II, with an enrollment of an additional 38 patients. All patients will also be given quality of life (QOL) instruments pretreatment, weekly during treatment, then q 3 months for year 1 post treatment, q6 months year 2 & 3 and yearly for year 4 & 5. Comparisons will be made between the enrolled subjects receiving proton therapy and the known literature on photon radiation. See section 2 for full objectives. The second phase will begin no earlier than 60 days after the last patient in the initial phase has completed treatment and once safety and feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.
详细描述
Primary Objectives:
The primary objectives of this study are feasibility and safety. The study will be deemed infeasible if greater than 10% of pts experience one of the following:
- Patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised.
(95% of target volume covered by 95% of the dose)
- Patient is unable to tolerate 20% of treatments (for any reason unable to set patient up within acceptable limits of tolerance, patient unable to tolerate treatment position or immobilization for duration of treatment) using proton radiotherapy (up to 80% of treatments could be delivered using photons).
- Patient is unable to complete all of his/her treatments within 7 days of estimated date of treatment completion or requires a treatment break greater than 5 days. Toxicity will be deemed unacceptable if greater than 20% of patients experience acute toxicity, as defined in Section 7.12.
Secondary Objectives:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of WHO I-III meningiomas and hemangiopericytomas:
- •WHO grade I :
- •Tumor that are newly diagnosed and tumors that are incompletely excised
- •Tumors that have recurred post resection
- •WHO grade II:
- •Any tumor, either completely or incompletely excised
- •Any recurrent tumor
- •WHO grade III and hemangiopericytoma:
- •Any tumor, either completely or incompletely excised
- •Any recurrent tumor
- •Patients must have a Karnofsky Performance Status of
- •Age greater than 18 years Patients must be able to provide informed consent.
- •Adequate bone marrow function: WBC greater than 4000/mm3, platelets greater than 100,000 mm
- •Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.
排除标准
- •Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma).
- •Pregnant women, women planning to become pregnant and women that are nursing. Actively being treated on any other therapeutic research study.
- •Prior radiation to the brain.
结局指标
主要结局
Feasibility and Safety
时间窗: 90 days
For proton to deemed feasible, no greater than 10% of patients should experience a) Patient cannot be given treatment because anatomy is such that a dosimetically satisfactory treatment plan cannot be devised, b) Patient is unable to tolerate 20% of treatments using proton therapy, and c) patient is unable to complete all treatments within 7 days of estimated date of treatment completion
次要结局
- Health Related Quality of Life(5 Years)
- Progression free survival (PFS) and overall survival (OS)(5 Years)
- Late Toxicity(90 days)
- Fatigue - Brief Fatigue Inventory (BFI)(5 Years)
- Cumulative total dose (Gy) to normal brain tissue(8 Weeks)