A Phase II Clinical Trial on VEGF Expression Interfered by Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Treatment efficacy
研究概览
简要总结
The purpose of this study is to down-regulate VEGF expression in esophageal cancer patients by thalidomide, so to improve their chemoradiotherapy effect. Patients with esophageal cancer receiving chemoradiotherapy were divided into different sub-group according to dynamic change of their VEGF level,and those showed increased or unchanged VEGF were added thalidomide at random. Efficacy and side effect of thalidomide combined with chemoradiotherapy were evaluated, and at the same time, activity of thalidomide on esophageal cancer and its clinical safely were assessed.
详细描述
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-72Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 25 mg/m2/d, d1-4; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.
Administration of thalidomide: Determine serum VEGF level of the esophageal cancer patients 3-4 weeks after the beginning of radiotherapy, those whose VEGF level, compared with that before radiotherapy, increased or unchanged will be divided into two groups: one is given thalidomide concurrent with the following chemoradiotherapy, 100mg/d at bedtime for the initial week, and if no moderate above side effect occurred 200mg/d from the next week till the end of chemoradiotherapy; the other received concurrent chemoradiotherapy only.
VEGF determination: Peripheral venous blood samples will be taken in one week before, 3-4 weeks during, and in one week after radiotherapy respectively. The serum VEGF will be determined by the double antibody sandwich ELISA.
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
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •cytologically or histologically confirmed esophageal carcinoma
- •age of 20 -80
- •Karnofsky performance status ≥ 70
- •no treatments prior to enrollment
- •at least one measurable lesion on CT, MRI or esophageal barium exam
- •normal functions of heart, lung, liver, kidney and bone marrow
- •blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
- •informed consent signed
排除标准
- •prior treatments of chemotherapy or irradiation
- •poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable
- •contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
- •participating in other clinical trials
- •pregnancy, breast feeding, or not adopting birth control
- •drug or alcohol addiction, uncontrolled epileptic seizure, or psychotic with no ability of self control
- •coexisted morbidities that investigators believed not suitable for chemoradiation
研究组 & 干预措施
VEGF decressed
patients will receive concurrent chemoradiotherapy only
干预措施: chemoradiotherapy (Other)
thalidomide
patients will be given thalidomide concurrent chemoradiotherapy
干预措施: thalidomide (Drug)
without thalidomide
patients will receive concurrent chemoradiotherapy only
干预措施: without thalidomide (Other)
结局指标
主要结局
Treatment efficacy
时间窗: 3 months after completion of treatment
Treatment efficacy were evaluated by the indexes as Locoregional tumor response. Locoregional tumor response will be evaluated 3 months after completion of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST).
次要结局
- Overall survival (OS)(1 year and 3 years after completion of treatment)
- Local progression-free survival (LPFS)(1 year and 3 years after completion of treatment)
- Safety(1 week after completion of treatment)
研究者
Suping Sun
Director, Head of Radiation oncology, Principal Investigator, Clinical Professor
Changzhou No.2 People's Hospital