A Multicenter, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- short-time effect
研究概览
简要总结
A total of 120 patients with pathologically confirmed Locally advanced cervical carcinoma were enrolled. Patients were randomly divided into two groups, with 60 patients in each group. One group was treated with Concurrent Chemoradiotherapy combined with Endostar and the other group was treated with Concurrent Chemoradiotherapy. The short term efficacy and the toxic of these treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free survival of patients were analyzed. The investigators data may provide an alternative option for the treatment of Locally advanced cervical carcinoma with high efficacy and low toxicity.
详细描述
This study was a multicenter, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. Nine medical centers participated in this study and 120 patients with pathologically confirmed Locally advanced cervical carcinoma were enrolled. These patients were randomly divided into two groups: concurrent chemoradiotherapy combined with Endostar group ( IMRT 45-50Gy, DDP 40mg/m2, per week for 5cycles, Endostar: 7.5mg/m2 d1-10, repeat every 15 days, for 4 cycles) and concurrent chemoradiotherapy group ( IMRT 45-50Gy, DDP 40mg/m2, per week, for 5cycles). After treatment, follow-up was performed every 3 months. The treatment toxicity, local control rate, distant metastasis-free survival, overall survival, progression-free survival were observed and assessed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients of either gender and aged from 18 to 65 years old.
- •patients with histologically confirmed cervical carcinoma.
- •patients at stage Ib, IIa2, IIb-IVa by FIGO 2009 staging.
- •KPS ≥ 70 (Appendix I)
- •patients with available MRI or CT data of cervical and measurable tumor lesions.
- •patients did not receive any treatment before enrollment.
- •patients with expected survival longer than 6 months.
- •biochemical indexes: WBC > 4,000/mm3, and blood platelet ≥ 100,000 mm3; PT≤UNL; levels of indicators for hepatic and renal function was 1.5 folds of the upper limit of normal value.
- •the informed content was obtained from every patient.
- •patients with effective follow-up.
排除标准
- •those with malignant tumors other than cervical carcinoma.
- •those received treatments before enrollmment.
- •lactating women and Pregnant woman.
- •those who were undergoing other drug trials.
- •those with severe complications, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, mental illness and uncontrollable diabetes.
- •those who were treated with tumor targeting drugs.
- •those who could not subject to MRI or CT examination.
- •those who could not meet the requirements of the prescribed dose.
研究组 & 干预措施
concurrent chemoradiotherapy + endostar
4 cycles of Endostar and 5 cycles of DDP concurrent with radiotherapy
干预措施: Endostar (Drug)
concurrent chemoradiotherapy + endostar
4 cycles of Endostar and 5 cycles of DDP concurrent with radiotherapy
干预措施: DDP (Drug)
concurrent chemoradiotherapy
5 cycles of DDP concurrent with radiotherapy
干预措施: DDP (Drug)
结局指标
主要结局
short-time effect
时间窗: 3 months
3 months after treatment, the subjects go into observation period. MRI/CT will be used for evaluating the carcinoma status.
次要结局
- Overall Survival(3 years,5 years)
- Progression-Free Survival(3 years,5 years)
研究者
Yong Zhang,MD
MD
First Affiliated Hospital of Guangxi Medical University