Spatially Fractionated Radiation (SFR) Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire
研究概览
简要总结
Palliative radiation therapy represents 40% of the on-going radiation at the Jewish General Hospital. In a traditional palliative radiation treatment to bulky or radioresistant tumors, radiotherapy schema varies from 24 to 30 Gys given in 3 to 10 fractions, depending on the tumor size, tumor location and tumor pathology. However, for many patients this treatment involves considerable toxicity, travel and time spent at the hospital. Spatially fractionated radiation (SFR) is an alternative technique that consists in delivering one single treatment, given through a grid containing holes. The present study is proposing to validate SFR as a safe and effective mean to palliate patients with symptomatic bulky tumors (more than 8 cm) or with tumors known to be resistant to radiation.
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
- •Patient with histologically or cytologically confirmed malignancy. All malignant histologies/cytologies are eligible.
- •Patient with bulky tumor (larger than 8cm), or with a tumor known to be resistant to radiation (eg. Melanoma, hypernephroma, sarcoma), or with a tumor previously irradiated with a palliative intent requiring more than 1 fraction of radiation
- •Patient planned to undergo palliative radiation therapy treatments to one of the following 5 sites: extremities, neck, chest, abdomen and pelvis
- •WHO performance status of 0-2
- •Aged 18 years or older
- •Ability to sign and understand an informed consent form
排除标准
- •Potentially curable patient
- •Previous palliative radiation with hypofractionation
- •Tumor located near the spinal cord or in the brain
- •Pregnant or nursing woman
研究组 & 干预措施
GRID radiation therapy
A single dose of 15-20Gys of spatially fractionated radiation therapy
干预措施: spatially fractionated radiation therapy (Radiation)
结局指标
主要结局
Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire
时间窗: 3 months post treatment
次要结局
- Tumor response, measured on CT-scan(8 weeks)
- Cost-effectiveness, as measured by evaluating the cost of the procedure per patient and the efficacy of treatment with regards to symptom relief and tumor response(3 months)
- Acute toxicity of treatment, as measured using the CTCAE grading system (v4.0)(1 week)
- Long-term toxicity of treatment, as measured using the CTCAE grading system (v4.0)(3, 6, 9, 12 months)
研究者
Dr. Te Vuong
Director, Radiation-oncology department
Sir Mortimer B. Davis - Jewish General Hospital