Clinical Research of Moderately Hypofractionated Radiotherapy for Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acute toxicity
研究概览
简要总结
External radiation given in 25 fractions or so together with weekly chemotherapy and followed by 5 or 6 fractions of brachytherapy is the standard of care for patients with locally advanced cervical cancer. We hope to develop external moderately hypofractionated radiotherapy of cervical cancer based on adaptive radiotherapy.The objective of this study is to evaluate the efficacy and treatment-related toxicity of moderately hypofractionated adaptive radiotherapy in the treatment of cervical cancer.
详细描述
This is an investigator-initiated efficacious, single-center, open-label clinical trial study. This study hypothesizes that the use of external moderately hypofractionated radiotherapy of cervical cancer based on adaptive radiotherapy. A dose of 43.35Gy in 17 fractions is delivered to clinical target volume (CTV). Patients receive cisplatin based concurrent chemotherapy. The primary endpoint is acute toxicity.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years to 70 years
- •FIGO Stage IB1, IB2, IB3, IIA or IIB cervical cancers
- •FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria:largest node is less than 1.5 cm,less than 3 pathological nodes,No nodes located in the common iliac chain
- •Histology: squamous
- •Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin
- •Brachytherapy candidate
- •Functional State Eastern Cooperative Oncology Group (ECOG)0-2
排除标准
- •Patients who had chemotherapeutic, surgical and/or radiotherapy treatment
- •FIGO stage IIIA, IIIB, IIIC2, IVA or IVB
- •FIGO stage IIIC1 with node greater than 1.5 cm, common iliac node or greater than 2 pathological nodes
- •Previous pelvic or abdominal radiotherapy
- •Patient unable to undergo MR scan
- •ECOG performance status greater than 2
- •Not a cisplatin candidate
- •Other factors that contraindicate experimental therapy
结局指标
主要结局
Acute toxicity
时间窗: 3 months
This outcome is assessed by physicians during each follow-up appointment, and scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 . Clinically relevant toxicities of gastrointestinal, genitourinary, vaginal and non-specific general symptoms (i.e. fatigue, malaise and pain) will be collected. Hematological disorders will also be collected through weekly blood work checks. Acute toxicities will be collected at baseline, and then weekly during radiotherapy/chemoradiotherapy and at 3 months after completion of radiation.
次要结局
- Assessment of tumor regression throughout EBRT(3 months)
- Late toxicity(3 years)
- Response evaluation evaluated with RECIST 1.1(One month after treatment)
- Disease-free survival(3 years)
- Overall survival(3 years)
- Quality of life (QoL)(3 years)