Proton Radiation For Chordomas and Chondrosarcomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Feasibility of Proton RT for Chordomas and Chondrosarcomas
研究概览
简要总结
The objectives of this study are 1) To evaluate the feasibility and acute side effects of proton therapy for chordomas and chondrosarcomas and 2) To evaluate clinical outcomes and long term side effects of proton beam radiation for treatment of chordomas and chondrosarcomas.
详细描述
This trial will be conducted in two phases: a feasibility then a phase II trial. Once feasibility and safety are established in the first 12 pts. the phase II study will begin. Proton therapy at standard doses is not known to improve clinical outcome but will likely reduce fatigue and toxicity.
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 chordoma or chondrosarcoma.
- •Patients must have no evidence of metastatic disease based on routine imaging (CT or MRI of the chest/abdomen/pelvis, bone scan, etc.)
- •Patients must have an ECOG score equal to or less than
- •Age ≥ 18 years.
- •Patients must be able to provide informed consent.
- •Adequate bone marrow function: WBC ≥ 4000/mm3, platelets ≥ 100, 000mm3
- •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.
- •Tumors arising in the skull and spine.
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)
- •Patients with the following histologies are excluded: melanoma , other soft tissue or bony sarcomas, giant cell tumor aneurismal bone cyst or metastatic lesions from other histologies.
- •Pregnant women.
- •Actively being treated on any other therapeutic research study.
- •Tumors arising outside of the CNS.
结局指标
主要结局
Feasibility of Proton RT for Chordomas and Chondrosarcomas
时间窗: From enrollment to treatment completion or withdrawal, whichever occurred first, assessed up to 133 months
The purpose of this study was to evaluate the feasibility and safety of dose-escalated proton beam therapy for treating chordomas and chondrosarcomas of the skull base and spine. The feasibility, as defined by ≥10% of patients experiencing either: unsatisfactory dosimetry, inability to complete all of his/her treatments within 10 days of estimated completion date and requiring no break \>5 days, and no greater than 20% of patients experiencing ≥grade 3 toxicity from RT.
次要结局
- Acute Toxicities(With in the 90 days from tx start date)
- Late Toxicities(Every 3 months for 3 Years from the tx start date and assessed up to 133 months)