A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Overall Response at Protocol Treatment Site
研究概览
简要总结
The goal of the first part of this clinical research study is to learn how to deliver more accurate radiation treatment of tumors in the spine. Researchers also want to learn how internal organs might move during radiation treatment.
The goal of the second part of this study is to learn if it is safe to allow slightly more radiation to the normal esophagus when spinal tumors close by are being treated. This may result in better tumor control.
详细描述
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of 10 participants will be enrolled in the first part of the study, and up to 2 groups of 10 participants will be enrolled in the second part of the study. Only participants who will receive a single spinal SBRT treatment are eligible for the second part of the study.
The participants in the first part of the study will receive standard doses of radiation therapy to normal organs while treating the tumor. In the second part of the study, each new group will receive a higher dose of radiation to the esophagus than the group before it, if no intolerable side effects were seen.
Radiation Planning and Treatment:
Before starting radiation treatment, you will be asked to complete a questionnaire about any symptoms you might be having and any drugs that you are taking. It should take about 10 minutes to complete. After treatment, you will be given copies of the questionnaire to take with you, and asked to fill it out 1 time a week for the next 4 weeks. You should return the questionnaires by mail. Self-addressed stamped envelopes will be given to you.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •STAGE 1: >/= 18 years old
- •STAGE 1: Pathologically confirmed diagnosis of cancer, including, but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and carcinoma of unknown primary
- •STAGE 1: Signed informed consent
- •STAGE 2: 1-3 above, and Patients undergoing single fraction spinal SBRT
排除标准
- •STAGE 1: Patient with radiosensitive histologies (lymphoma, multiple myeloma, small cell carcinomas, germ cell tumors)
- •STAGE 1: Extensive (> 50%) height loss of the involved vertebral body
- •STAGE 1: Inability to tolerate lying flat on treatment table for greater than 30 minutes
- •STAGE 1: Pregnancy
- •STAGE 2: Prior irradiation of the spine site and level to be treated
- •STAGE 2: Patients with primary disease arising in the posterior elements of the VB in question
- •STAGE 2: History of Barrett's esophagus, esophageal webbing, stricture, or fistula
- •STAGE 2: Prior radiation to the esophagus
研究组 & 干预措施
Hypofractionated Radiation
All patients receive CT-guided spinal SBRT using IMRT to maximize conformality of treatment plan to target volume, while sparing normal structures. Dose given to tumor and number of treatments received determined by patient's doctor.
In second stage, characterize tolerance of esophagus to hypofractionated radiation doses through prospective constraint relaxation and toxicity monitoring. Data collected from Group 1 in first stage will give data on dose delivered to esophagus. Second stage of protocol will begin accrual once Group 1 has filled. Dose constraints used for Groups 3 allow higher dose. Dose constraints for Group 4 represent modest increase of esophageal dose maximums.
干预措施: Spinal SBRT (Higher Dose) (Radiation)
Hypofractionated Radiation
All patients receive CT-guided spinal SBRT using IMRT to maximize conformality of treatment plan to target volume, while sparing normal structures. Dose given to tumor and number of treatments received determined by patient's doctor.
In second stage, characterize tolerance of esophagus to hypofractionated radiation doses through prospective constraint relaxation and toxicity monitoring. Data collected from Group 1 in first stage will give data on dose delivered to esophagus. Second stage of protocol will begin accrual once Group 1 has filled. Dose constraints used for Groups 3 allow higher dose. Dose constraints for Group 4 represent modest increase of esophageal dose maximums.
干预措施: Gold Seed Implantation (Procedure)
Hypofractionated Radiation
All patients receive CT-guided spinal SBRT using IMRT to maximize conformality of treatment plan to target volume, while sparing normal structures. Dose given to tumor and number of treatments received determined by patient's doctor.
In second stage, characterize tolerance of esophagus to hypofractionated radiation doses through prospective constraint relaxation and toxicity monitoring. Data collected from Group 1 in first stage will give data on dose delivered to esophagus. Second stage of protocol will begin accrual once Group 1 has filled. Dose constraints used for Groups 3 allow higher dose. Dose constraints for Group 4 represent modest increase of esophageal dose maximums.
干预措施: Questionnaires (Behavioral)
ExacTrac Positioning System
Analysis performed of ExacTrac positioning system with and without fiducial guidance. Four dimensional CT datasets for simulation will allow use of data from this portion of protocol to characterize degree to which organ at risk (OAR) motion is relevant at each spinal level. 20 patients accrued in two groups of 10, with 10 patients in each rostral-caudal position in the spine (Group 1: T4-T12, Group 2: L1-L5). Imaging done with fiducial markers for this study will not impact patient management. Patients will treated with standard dose constraints to normal tissues.
干预措施: Spinal SBRT (Standard Dose) (Radiation)
ExacTrac Positioning System
Analysis performed of ExacTrac positioning system with and without fiducial guidance. Four dimensional CT datasets for simulation will allow use of data from this portion of protocol to characterize degree to which organ at risk (OAR) motion is relevant at each spinal level. 20 patients accrued in two groups of 10, with 10 patients in each rostral-caudal position in the spine (Group 1: T4-T12, Group 2: L1-L5). Imaging done with fiducial markers for this study will not impact patient management. Patients will treated with standard dose constraints to normal tissues.
干预措施: Gold Seed Implantation (Procedure)
ExacTrac Positioning System
Analysis performed of ExacTrac positioning system with and without fiducial guidance. Four dimensional CT datasets for simulation will allow use of data from this portion of protocol to characterize degree to which organ at risk (OAR) motion is relevant at each spinal level. 20 patients accrued in two groups of 10, with 10 patients in each rostral-caudal position in the spine (Group 1: T4-T12, Group 2: L1-L5). Imaging done with fiducial markers for this study will not impact patient management. Patients will treated with standard dose constraints to normal tissues.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Overall Response at Protocol Treatment Site
时间窗: 10 years and 9.5 months
Patients will be monitored at each follow-up visit, with MRI of the spine performed at each follow-up time point during the first year. Treated lesions will be classified as progressive (defined as \> 25% increased volume), stable (defined as radiographically unchanged), or smaller, and spinal tumor progression-free survival (PFS) will be calculated.
次要结局
未报告次要终点