NCT04235179招募中2 期
Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer (ASPIRE)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acute Treatment-Related Adverse Events
研究概览
简要总结
Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 30 Gy in 5 fractions, once weekly to the pelvis in post operative patients with endometrial 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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient with histologically confirmed endometrial adenocarcinoma
- •Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions: High grade histology OR Outer-half myometrial invasion with any risk factors OR FIGO stage II - IIIC
- •Age ≥18 years.
- •Patients who are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments.
排除标准
- •Patient has had prior pelvic radiotherapy.
- •Patient has Type II endometrial cancer histology (ie. Serous, clear cell or carcinosarcoma).
- •Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
- •Patient has a contraindication to CT contrast.
- •Patient has a hip prosthesis.
结局指标
主要结局
Acute Treatment-Related Adverse Events
时间窗: 3 months after accrual is completed
The number of participants with acute (\<3 months) urinary and bowel treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria
次要结局
- Late Treatment-Related Adverse Events(5 years after accrual is completed)
- Disease Local-Regional Failure Rate(5 years after accrual is completed)
- Quality of Life(5 years after accrual is completed)
研究者
Dr. Yasir Alayed
Consultant and Assistant Professor
King Saud University
研究点 (1)
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