Definitive Re-irradiation With Proton Beam Radiotherapy for Patients With Recurrent Thoracic Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment
研究概览
简要总结
This pilot clinical trial studies proton beam radiation therapy in treating patients with thoracic cancer that has come back and have received prior radiation therapy. Proton beam radiation therapy uses high energy protons to kill tumor cells and may cause less damage to normal tissue.
详细描述
PRIMARY OBJECTIVES:
I. To assess the grade 3 toxicity associated with thoracic re-irradiation with proton therapy, with prospectively applied normal organ radiation dose limits.
SECONDARY OBJECTIVES:
I. To assess the efficacy of thoracic re-irradiation with proton therapy.
OUTLINE:
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women of child-bearing age must have a negative pregnancy test
- •Patients must have received prior radiation treatment to the chest; records of prior radiation treatment must be available
- •Patients must have received prior chest radiation at least 3 months prior to enrollment in this trial; radiation treatment to other body sites not overlapping with current radiation fields are allowed within the 3 months period (example, brain radiation is allowed)
- •Patients must have a prior diagnosis of cancer inside the thoracic cavity; both primary thoracic malignancies (such as lung cancer) as well as metastatic lesions (such as metastatic breast cancer or colorectal cancer to the lungs) are allowed; patient must have pathologic confirmation of the recurrent thoracic tumor, or have an enlarging thoracic mass (as seen on two computed tomography [CT] scans at least 6 weeks apart, with either a > 25% or > 5 mm increase in longest dimension)
- •Patients must have a life expectancy of > 6 months
- •Patients must have measurable disease to be treated with proton radiation (minimum tumor dimension at least 10 mm on CT imaging)
- •Patients should have either non-metastatic cancer of the thorax, or metastatic cancer to the thorax and candidate for definitive radiation dose to the thoracic tumor (not palliative intent), tumor radiation dose to at least BED2Gy 60 Gy
- •Patients must be able to receive proton radiation treatment
- •All stages of cancer are eligible
- •There are no limits on prior therapy; patients are allowed to have prior chemotherapy and surgery; patients are allowed to have concurrent chemotherapy with radiation treatment; patients are allowed to have chemotherapy or surgery after radiation treatment
- •Patients are allowed to be on another study concurrent with this protocol
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients who have never received radiation to the chest
- •Patients who received radiation to the chest within the past 3 months (in a region that overlaps with current radiation fields)
- •Patients with life expectancy < 6 months
- •Pregnant women
- •Patients unable to provide informed consent
- •Prisoners
研究组 & 干预措施
Treatment
Proton beam radiation therapy
干预措施: Proton Beam Radiation Therapy (Radiation)
结局指标
主要结局
Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment
时间窗: Up to 3 months post-treatment
Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 generally means hospitalization required for management of side effects.
次要结局
- Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment(Up to 3 months post-treatment)
- Number of Participants With Local Control of Cancer(Up to 3 months post-treatment)
- Number of Participants Alive(Up to 3 months post-treatment)
研究者
Jing Zeng
Principal Investigator
University of Washington