ChiCTR2500110542尚未招募3 期
A Comparative study between Induction Chemotherapy Followed by Concurrent Chemoradiation versus Concurrent Chemoradiation in the Management of Locally Advanced Uterine Cervical Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 试验地点
- 2
- 主要终点
- The clinical response rate at the end of induction chemotherapy
研究概览
简要总结
This study aims to explore the efficacy and tolerability of induction chemotherapy followed by chemoradiation versus conventional therapy chemoradiation in patients with locally advanced uterine cervical cancer.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 性别
- Female
入选标准
- •1.Age between 18 and 70 years;
- •2.Clinically staged as IB3–IVA according to the International Federation of Gynecology and Obstetrics (FIGO);
- •3.Histologically proved squamous cell carcinoma or adenocarcinoma of the uterine cervix;
- •4.Performance status 0–2 according to Word Health Organization (WHO) criteria;
- •5.Normal hematological, renal and hepatic function.
排除标准
- •1.Severe systemic or uncontrolled disease (infection, central nervous system, metabolic, etc.) that precluded the use of chemotherapy;
- •2.Pre-existing high grade neuropathy of any cause;
- •3.Histologically proved small cell carcinoma, leiomyosarcoma, lymphoma and other histopathologies other than Squamous cell carcinoma & adenocarcinoma;
- •4.Mental illness;
- •5.Previous or concomitant malignancies.
研究组 & 干预措施
A group
B group
结局指标
主要结局
The clinical response rate at the end of induction chemotherapy
时间窗: 2 Years
Overall survival rate
时间窗: 2 Years
次要结局
- Progression free survival(5 years)
- Disease-free survival(5 years)
- Adverse events associated with the treatment(5 years)
研究者
研究点 (2)
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