Endoesophageal Brachytherapy for Patients With Esophageal Cancer: A Balloon Repositioning, Multichannel Radiation Applicator for Optimizing Treatment Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Dose of Radiation Delivered to 90% of Tumor Volume (D90)
研究概览
简要总结
Depending upon the cancer stage, esophageal cancer can be treated with surgery, chemotherapy, radiation therapy, or a combination of these modalities. Sometimes in addition to external radiation therapy or instead of external radiation therapy, select patients with esophageal cancer may benefit from localized radiation to the tumor, called esophageal brachytherapy. There are many different radiation techniques and delivery approaches for this type of specialized radiation therapy, and the purpose of this document is to provide a written summary of an innovative delivery method.
详细描述
Primary Objective Pilot study of multichannel endoesophageal brachytherapy applicator to determine dose distribution and conformality of a 6 channel balloon repositioning applicator.
Secondary Objective(s)
- To collect data in order to show how the 6-tube endoesophageal brachytherapy technique will be an improvement (more conformed dose distribution) over a previously designed 3-tube endoesophageal brachytherapy technique in patients who are candidates for esophageal brachytherapy
- To evaluate acute toxicity of novel endoesophageal brachytherapy applicator.
Study Design
This innovative study will be an improvement over a previously designed 3-tube endoesophageal brachytherapy technique in patients who are candidates for esophageal brachytherapy. The brachytherapy planning process will utilize a novel multichannel balloon applicator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Biopsy-proved esophageal adenocarcinoma or squamous cell carcinoma
- •Disease that can be encompassed in the radiotherapy treatment field
- •Women of childbearing potential must practice adequate contraception
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document
排除标准
- •Concurrent chemotherapy at the time of brachytherapy treatments
- •Tracheal or bronchial involvement
- •Cervical esophagus location
- •Stenosis that cannot be bypassed or dilated to allow for applicator placement
- •Not willing or unable to provide informed consent
- •History of esophageal fistula
研究组 & 干预措施
brachytherapy with multichannel balloon applicator
6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors
干预措施: Endoesophageal Brachytherapy (Device)
结局指标
主要结局
Dose of Radiation Delivered to 90% of Tumor Volume (D90)
时间窗: Up to 6 months of follow-up
Percent of prescription dose received by 90% of PTV (planning target volume)
Percent Volume of the Tumor Receiving the Prescription Dose (V100)
时间窗: Up to 6 months of follow-up
Percent volume of the tumor receiving 100% of the prescription dose calculated as the mean from the total weekly HDR brachytherapy treatment plans
次要结局
- Dose of Radiation to Organ at Risk (Bronchus)(Up to 6 months of follow-up)
- Tumor Response Based on Resist Criteria(Up to 6 months of follow-up)
- Radiation Treatment Volume(Up to 6 cycles (6 weeks) of treatment)
- Dose of Radiation to Organ at Risk (Heart)(Up to 6 months of follow-up)
- Dose of Radiation to Organ at Risk (Aorta)(Up to 6 months of follow-up)
- Number of Participants With Esophageal Ulceration(Up to 6 cycles (6 weeks) of treatment)
- Number of Participants With Esophageal Fistula(Up to 6 cycles (6 weeks) of treatment)
- Number of Particiapants With Esophageal Stricture(Up to 6 cycles (6 weeks) of treatment)
- Number of Participants With the Need for Dilation(Up to 6 cycles (6 weeks) of treatment)