a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer (SISTER-RAY)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Acute G3 or higher Gastrointestinal and Genitourinary Toxicity
研究概览
简要总结
The primary endpoint of the present prospective study is to assess the outcomes in terms of acute toxicity of post-operative stereotactic radiotherapy for endometrial cancer
详细描述
Endometrial cancer represents the sixth global female cancer, and adjuvant radiotherapy has a main role in the management of these patients.
This treatment usually covers the surgical bed, the upper portion of the vagina and the pelvic lymph nodes. In the last decades, the technological progress has allowed clinicians to offer a more accurate planning and delivery of the treatment with modern IMRT-IGRT techniques.
Nonetheless, radiotherapy regimens were still based on 25-30 fractions schedules. More recently, similarly to other oncological settings like prostate, breast or rectal cancer, 5-fractions schedules have been considered as potentially useful also in this setting.
On this purpose, this study aims to investigate the feasibility of a shorter adjuvant radiotherapy treatment for endometrial cancer, by assessing acute and late toxicity, quality of life and clinical outcomes.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •ECOG PS ≤ 2 or KPS ≥ 70%
- •Patients diagnosed with endometrial cancer (endometrioid, serous cell, clear cell, carcinosarcoma) FIGO stage IB-IIIC1 candidate to post-operative external beam radiotherapy, based on molecular and histological findings
- •Indications for chemotherapy and/or brachytherapy are not
排除标准
- •for the purpose of the study
- •Written Informed Consent
- •Exclusion Criteria:
- •Prior pelvic radiotherapy
- •Para-aortic lymph nodes involvement
- •ECOG PS ≥ 3
- •Any diagnosis of inflammatory bowel disease (both active or quiescent)
结局指标
主要结局
Acute G3 or higher Gastrointestinal and Genitourinary Toxicity
时间窗: From the end of treatment to a time interval of 12 weeks
The number of any G3 or higher adverse event occurring within 90 days from the end of radiotherapy and assessed according to the CTCAE v5.0 criteria
次要结局
- Distant Progression Free Survival(From enrollment to a follow-up time of 5 years)
- Overall Survival(From enrollment to a follow-up time of 5 years)
- Late Gastrointestinal and Genitourinary Toxicity(From enrollment to a follow-up time of 5 years)
- Local Control(From enrollment to a follow-up time of 5 years)
- Overall Quality of Life(From enrollment to a follow-up time of 5 years)
研究者
Francesco Cuccia, MD
Principal Investigator
ARNAS Civico Di Cristina Benfratelli Hospital