Influence of Radiation Patterns Following Circadian Rhythm Upon Response of Radiotherapy of Uterine Cervical Cancer : Melatonin as a Radiosensitivity and Biological Marker
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- Radiation response
研究概览
简要总结
The study was a Randomized Clinical Trial (RCT) or clinical trial comparing the results of radiation treatment of 2 treatment groups, i.e. subject groups irradiated in the morning and in the afternoon, to check melatonin levels in cervical cancer patients. Since it is known that the function of melatonin is as an antiproliferation substance or hormone, induces apoptosis, inhibits invasion and metastasis.
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 (Care Provider)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cervical cancer patients stage IIB-IIIB (FIGO)
- •no previous treatment
- •histopathologic examination results of squamous cell carcinoma (SCC)
- •KPS > 70 with levels of Hb > 10 g%,
排除标准
- •Distant metastasis and locally spread to the adjacent healthy tissue (urinary bladder or rectum).
结局指标
主要结局
Radiation response
时间窗: Four weeks after the completion of radiation
We assessed the change in tumor size between the initial examination and the fourth week after the completion of irradiation, to classify the tumor response based on the modified WHO criteria which categorized as good response or poor response.
次要结局
未报告次要终点
研究者
Irwan Ramli, Sp.Onk. Rad(K)
Consultant of Radiation Oncology
Indonesia University