Weekly Cisplatin or Weekly Liposome Paclitaxel Concurrent Radiation Therapy in Treating Elderly People With Cervical Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 45
- 主要终点
- Objective Response Rate
研究概览
简要总结
The purpose of this study is to evaluate the efficiency and safety of weekly Cisplatin /Liposome paclitaxel concurrent chemoradiothrapy in the treatment of locally advanced cervical cancer in elderly women.
详细描述
Concurrent radiotherapy is the standard treatment of inoperable cervical cancer .Due to the physical conditions, elderly patients usually associated with medical complications, so generally just receive radiotherapy alone. Recently, some retrospective studies have shown that the impact of chemotherapy did not cause an increase in the complication rate among elderly patients as compared to younger patients with cervical cancer, and may improve the survival when concurrent with radiotherapy. Cisplatin and paclitaxel are two effective drug in treating cervical cancer, but whether they are safe enough for elderly when concurrent with radiotherapy, there are no clearly reports. In this study ,we replace the conventional dose chemotherapy with weekly cisplatin or lipsome paclitaxel , to compare the efficiency and safety of weekly cisplatin / liposome paclitaxel concurrent chemoradiotherapy and radiotherapy alone in the treatment of cervical cancer in elderly patients.
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
- 65 Years 至 80 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven squamous carcinoma of cervix
- •FIGO stageⅡB and ⅢB
- •Over 65 years
- •Do not receive other treatment
- •Performance index ECOG grade 0 to 2
- •Normal hematological parameters
- •Normal renal and liver function tests
排除标准
- •Concomitant disease which may adversely affect the outcome
- •Poor nutritional status
- •Medical or psychological condition precluding treatment
- •Previous treatment
- •Concurrent treatment for any cancer
研究组 & 干预措施
Radiotherapy alone
干预措施: irradiation (Radiation)
Radiotherapy plus cisplatin
干预措施: Cisplatin (Drug)
Radiotherapy plus liposome paclitaxel
干预措施: liposome paclitaxel (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 1 month after the treatment completed
Objective Response Rate: Complete response (CR)+ Partial response (PR) rates base on RECIST evaluation system.
Adverse Events
时间窗: Participants will be followed from the treatment begin to 1 month after the treatment end.
Record the Number of participants with adverse events and the Grades of the AE according to CTCAE v3.0
次要结局
- Local Control Rate(Participants will be followed every year for the duration of 5 years)
- Tumor Free Survival Rate(From date of randomization until tumor recurrence or metastasis,assessed up to 5 years)
- Overall Survival Rate(From date of randomization until the date of death from any cause,assessed up to 5 years)
研究者
Liu Zi
Profesor
Health Science Center of Xi'an Jiaotong University