IMRT Tomotherapy for Esophagus Cancer: A Phase I Feasibility Study in Non-Operative Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in patients with unresectable esophagus cancer.
研究概览
简要总结
Concurrent chemotherapy and radiation therapy are the standard of care for inoperable patients with esophagus cancer. Unfortunately, the 5-year survival of 20% for this population is quite low. Methods to intensify radiation therapy delivery without increasing local toxicities are needed. Intensity modulated radiation therapy (IMRT) is an advanced method of delivering external beam radiation that may minimize the volume of normal tissue irradiated to high dose and thus decrease the risk of normal tissue toxicity. The proposed study will prospectively test whether IMRT is tolerable for delivering IMRT doses of 60 Gy for patients with esophagus cancer.
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
- •Age >= 18
- •Karnofsky Performance Status of >= 60
- •TNM Stages T1-4, N0-3, M0
- •Pathologic confirmation of esophagus cancer
- •Evaluation by medical oncologist determines that the patient is medically fit for concurrent chemotherapy
- •Evaluation by surgeon determines that patient is unresectable
排除标准
- •Age < 18
- •Karnofsky Performance Status < 60
- •Radiographic or pathologic evidence of distant metastatic disease (classified as M1b in AJCC staging manual)
- •Prior radiation therapy to the thorax or upper abdomen, preventing definitive radiation therapy.
- •Pregnant or lactating, if female.
结局指标
主要结局
The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in patients with unresectable esophagus cancer.
时间窗: One year after protocol registration
The study will be deemed infeasible if one or more of the following results occur: * 15% of patients experience any grade 4 acute toxicity judged to be related to his/her external radiation treatment * within 1 year of protocol registration, \>15% of patients develop any grade 4 late toxicity judged to be related to his/her external radiation treatment * within 1 year of protocol registration, any patient dies from causes judged to be related to his/her external beam radiation treatment
次要结局
- Evaluate local recurrence rates(Until patient progressive disease or death)
- Evaluate disease-free survival rates(Until patient progressive disease or death)
- Evaluate regional recurrence rates(Until patient progressive disease or death)
- Evaluate distant recurrence rates(Until patient progressive disease or death)
- Evaluate overall survival rates(Until patient progressive disease or death)