Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- compliance
研究概览
简要总结
Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and response rates with the weekly cisplatin based chemoradiation in the treatment of locoregionally advanced cervical cancers.
详细描述
This study is to compare the compliance, toxicity, response and survival rate between concurrent chemoradiation with weekly cisplatin 40mg/m2 and three-week cisplatin 75mg/m2 in patients with advanced cervical cancer. Patients with primary untreated invasive squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix from stage IIB to IVA were enrolled. Patients with histologically proven locoregionally advanced cervical cancer will be randomized into two treatment arm; Arm I, concurrent chemoradiation with weekly cisplatin 40mg/m2 for six times; Arm II, concurrent chemoradiation with three-week cisplatin 75mg/m2 for three times. The compliance and toxicity during the chemoradiation is the primary endpoint. Response rate and the overall survival will be analyzed as secondary endpoints.
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
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven cervical cancer
- •Squamous, Adenosquamous, Adeno carcinoma cell type
- •International Federation of Gynecologic Oncology (FIGO) stage IIB - IVA
- •Gynecologic Oncology Group (GOG) performance status 0 - 2
排除标准
- •Previous history of chemotherapy or radiation
- •History of other cancer
- •Hypersensitivity to platinum agents
- •Pregnancy
- •Serious medical disease
研究组 & 干预措施
weekly cisplatin
Weekly cisplatin 40mg/m2 during radiation therapy
干预措施: radiation (Radiation)
weekly cisplatin
Weekly cisplatin 40mg/m2 during radiation therapy
干预措施: weekly cisplatin (Drug)
tri-weekly cisplatin
cisplatin 75mg/m2 three cycles, every 3 weeks
干预措施: radiation (Radiation)
tri-weekly cisplatin
cisplatin 75mg/m2 three cycles, every 3 weeks
干预措施: tri-weekly cisplatin (Drug)
结局指标
主要结局
compliance
时间窗: 3 month
1. Percentage of completed cycles of scheduled chemotherapy in each arm 2. Percentage of grade III and IV toxicity 3. Delayed radiation time due to toxicity
次要结局
- survival(5 years)
研究者
Sang-Young Ryu
Chair of Cerivcal/Ovarian Cancer Center
Korea Cancer Center Hospital