NCT06562166招募中2 期
Online Adaptive Radiotherapy (oART) in Radical Radiotherapy for Cervical Cancer - A Multi-center Randomized Controlled Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Acute non-hematological toxicity
研究概览
简要总结
This study aims to evaluate the clinical efficacy and safety of online adaptive radiotherapy for cervical cancer patients received radical radiotherapy. By comparing with image-guided radiotherapy, the study explores the potential advantages of online adaptive radiotherapy in reducing treatment toxicity and improving local control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •18-80 years old;
- •Pathologically confirmed diagnosis of cervical cancer and pathological type of cervical squamous carcinoma;
- •2018 FIGO Stage Ib3, II, IIIB and IIIC1
- •Proposed radical pelvic radiotherapy + concurrent sensitizing chemotherapy (platinum-based (cisplatin 30-40mg/m2 or carboplatin alone), starting concurrently in the first week, ≥5 courses)
- •ECOG score 0-2
- •Life expectancy greater than 6 months
- •Ability to remain lying down for more than 30 minutes
- •Patients were fully voluntary and autonomous and co-operated in signing the study informed consent form
- •Complete blood count and basal metabolic indexes within 14 days before enrolment must meet the following requirements: NEUT ≥ 1.5*109/L, HGB ≥ 60g/L, platelets ≥ 100×109/, blood creatinine <1.5 mg/dL. AST and ALT are within 2 times the upper limit of normal
- •Must complete baseline assessments and investigations required before treatment before enrolment
- •be eligible for regular follow-up
排除标准
- •Have received radiotherapy or chemotherapy in the past
- •Have undergone radical surgery for cervical cancer
- •Have a previous history of malignant tumor
- •Pregnant or lactating women
- •Presence of other serious co-morbidities such as poorly controlled cardiovascular, urinary, digestive, respiratory, hematological and central nervous system diseases.
研究组 & 干预措施
ART
Experimental
干预措施: online adaptive radiotherapy (Radiation)
IGRT
No Intervention
结局指标
主要结局
Acute non-hematological toxicity
时间窗: From the start of treatment until 3 months later
Acute non-hematologic toxicities include gastrointestinal and genitourinary toxicities, which will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
次要结局
- treatment response(3 months after completion of treatment)
研究者
研究点 (1)
Loading locations...
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