NCT03239626进行中（未招募）不适用
Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer: a Prospective Exploratory Trial (POHIM_RT Trial)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- acute toxicities according to CTCAE v4.0
研究概览
简要总结
To investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by hypofractionated intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •histologically confirmed cervical cancer
- •radical hysterectomy and pelvic lymph node dissection was done
- •histologically indicated adjuvant radiotherapy ( more than one as below)
- •tumor size ≥4 cm
- •positive lymphovascular invasion
- •more than half stromal invasion depth
- •ECOG performance status 0 or 1
- •Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl
排除标准
- •positive pelvic lymph node metastasis
- •positive distant metastasis (including retroperitoneal lymph node metastasis)
- •positive tumor involvement on resection margin
- •positive parametrial invasion
- •previous history of pelvic radiotherapy
- •more than 3 months after radical surgery for cervical cancer
- •neoadjuvant chemotherapy was done
- •previous history of other carcinoma except for thyroid cancer, skin cancer, in situ carcinoma on cervix
研究组 & 干预措施
POHIM-RT
Experimental
adjuvant hypofractionated IMRT for cervical cancer patients
干预措施: POHIM-RT (Radiation)
结局指标
主要结局
acute toxicities according to CTCAE v4.0
时间窗: 3 months
evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0
次要结局
- Progression free survival rate(5-years)
- late toxicities according to CTCAE v4.0(5-years)
研究者
研究点 (1)
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