A Multicenter, Prospective, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy and Concurrent Chemoradiotherapy in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 3-year Progression Free Survival
研究概览
简要总结
A total of 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal carcinoma were enrolled. Patients were randomly divided into two groups, with 150 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 and side effects 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 Locoregionally advanced nasopharyngeal carcinoma with high efficacy and low toxicity.
详细描述
This study was a multicenter, prospective, 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. Five medical centers participated in this study and 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal carcinoma were enrolled. These patients were stratified according to clinical stage and participating center, and were randomly divided into two groups: concurrent chemoradiotherapy combined with Endostar group ( IMRT 70-74Gy, Endostar 7.5mg / m2, 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy) and concurrent chemoradiotherapy group ( IMRT 70-74Gy, DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles). 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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients of either gender and aged from 18 to 70 years old.
- •patients with histologically confirmed non-keratinizing squamous cell nasopharyngeal carcinoma.
- •patients at stage III/IVb by UICC2010 staging.
- •KPS ≥ 70 (Appendix I)
- •patients with available MRI data of nasopharynx and measurable tumor lesions.
- •patients did not receive any treatment before enrollment.
- •patients with expected survival longer than 6 months.
- •biochemical indexes: hemoglobin > 120 g/L, WBC > 4 x 109 /L, and blood platelet ≥ 100 x 109 /L; levels of indicators for hepatic and renal function was 1.25 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 nasopharyngeal carcinoma, stage I non-melanoma skin cancer, and cervical carcinoma in situ.
- •those received treatments before enrollment.
- •pregnant or lactating women and reproductive women without contraception.
- •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 could not be followed up at regular intervals.
- •those who were treated with tumor targeting drugs.
- •those who could not subject to MRI examination.
- •those who could not meet the requirements of the prescribed dose.
- •those with hemorrhagic tendency.
研究组 & 干预措施
concurrent chemoradiotherapy + endostar
Drug: Endostar
Endostar 7.5mg / m2,3 cycles of intravenous infusion for ten days, and 2 cycles of maintenance therapy after radiotherapy
Drug: DDP
DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles
Radiation: IMRT
IMRT:70-74Gy
干预措施: Endostar (Drug)
concurrent chemoradiotherapy + endostar
Drug: Endostar
Endostar 7.5mg / m2,3 cycles of intravenous infusion for ten days, and 2 cycles of maintenance therapy after radiotherapy
Drug: DDP
DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles
Radiation: IMRT
IMRT:70-74Gy
干预措施: DDP (Drug)
concurrent chemoradiotherapy
Drug: DDP
DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles
Radiation: IMRT
IMRT:70-74Gy
干预措施: DDP (Drug)
结局指标
主要结局
3-year Progression Free Survival
时间窗: 3 years
The subjects were randomly divided into two groups. Group A: concurrent chemoradiotherapy combined with Endostar，including 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy，and Group B: concurrent chemoradiotherapy, concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go into observation period. MRI will be used for evaluating the carcinoma status. During 3 years, any relapse or death will be recorded.
次要结局
- 5-year Overall Survival(5 years)
研究者
min kang
doctor
First Affiliated Hospital of Guangxi Medical University