NCT03239613已完成不适用
Postoperative Hypofractionated Intensity-modulated Radiation Therapy with Concurrent Chemotherapy in Cervical Cancer: a Prospective Exploratory Trial (POHIM_CCRT Trial)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 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 concurrent chemotherapy with 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 chemoradiotherapy (more than one as below)
- •positive pelvic lymph node metastasis
- •positive parametrial invasion
- •positive tumor involvement on surgical margin
- •ECOG performance status 0 or 1
- •Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl
- •Kidney function: Creatinine <2.0 mg/dL, Bilirubin 1.5 mg/dl
排除标准
- •positive distant metastasis (including retroperitoneal lymph node metastasis)
- •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
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
- Late toxicities according to CTCAE v4.0(5-years)
- Progression free survival rate(5-years)
研究者
研究点 (2)
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