Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Time to Local Recurrence
研究概览
简要总结
The goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chordoma. The safety of this treatment will also be studied.
详细描述
Proton therapy is a kind of external beam radiation therapy where protons are directed to a tumor site. Researchers are trying to determine what level of proton therapy gives the most benefit without causing toxic side effects. Researchers will also be testing the treatment's effect.
If your doctor feels it is necessary, the proton beam therapy may be combined with standard photon therapy.
If you are eligible to take part in this study, you will receive proton beam therapy at The University of Texas (UT) MD Anderson Cancer Center (MDACC), and possibly photon beam, no sooner than 2 weeks after the last surgery to remove the tumor. You will receive proton beam therapy once a day for about 35 treatments (7 weeks). Treatment will be given for 5 days in a row each week (except for Saturdays, Sundays and holidays) at the MDACC Proton Center in Houston. The whole process should take up to 1 hour each day.
This is an investigational study. The proton beam machine used to deliver treatment is approved by the FDA for patient use. The doses being studied are experimental. About 15 participants will take part in this study. All will be enrolled at MDACC.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed chordoma of the skull base
- •Contrast enhanced postoperative MRI (CT in case MRI is contraindicated) of the skull base obtained within 90 days of study registration
- •MDACC surgeons have determined that optimal debulking of disease has been performed.
- •Karnofsky Performance status greater than or equal to 60
- •Signed informed consent
排除标准
- •Previous irradiation of the skull base
- •Documented evidence of disseminated metastatic disease
- •Any concurrent malignancy (other than non-melanoma skin cancers) in the last 3 years
研究组 & 干预措施
70 Gray (Gy) Proton Beam Therapy
Participants treated to 70 cobalt Gray equivalent (CGE) only (the standard treatment).
干预措施: Proton Beam Therapy (Radiation)
Photon Beam Therapy
Proton beam therapy combined with photon radiation therapy where combination improves final dose distribution.
干预措施: Proton Beam Therapy (Radiation)
Photon Beam Therapy
Proton beam therapy combined with photon radiation therapy where combination improves final dose distribution.
干预措施: Photon Beam Therapy (Radiation)
结局指标
主要结局
Time to Local Recurrence
时间窗: 1 year after radiation treatments
Recurrence classified as "central," "in-field", "marginal," "peripheral," or "distant" depending upon its relationship to the dose distribution on the original treatment plan. MRI (or CT in case MRI is contraindicated) of the skull base used to document the status of disease in the following categories: 1) stable disease, 2) progressive disease, 3) partial response/complete response. A post-operative MRI (or CT) obtained within 90 days of study registration serves as baseline with annual follow up till disease progression or death for any reason.
次要结局
未报告次要终点