NCT04115618Unknown2 期
Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic Esophageal Squamous Cell Carcinoma: a Phase II Study of Single Institution
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Toxicity Effect
研究概览
简要总结
This study was designed to predict the toxicity and efficacy of Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic I-IVA Esophageal Squamous Cell Carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytologic diagnosis of esophageal squamous carcinoma;
- •Aged 18-75 years;
- •Upper thoracic esophageal squamous carcinoma: the upper margin of the lesion is located between the entrance of esophagus and the inferior edge of the azygos vein;
- •Stage I-IVA(AJCC 6th,2009);
- •Not able to be surgically resection or rejected;
- •Not have received any prior anticancer therapy;
- •No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥4x109/L, Neutrophils (ANC )≥1.5x10^9/L, platelet count ≥100x 10^9/L, serum creatinine<1.5 mg/dL,urea nitrogen <8 mmol/L;
- •No history of malignancy;
- •No perforation of esophagus, no deep ulcer of esophagus;
- •Joined the study voluntarily and signed informed consent form.
排除标准
- •Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
- •Patient who has metastasis such as lung, liver metastasis;
- •Other malignant tumors;
- •Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
- •Uncontrollable heart disease, diabetes and hypertension, pulmonary fibrosis, and chest confirmed active pulmonary inflammation require antibiotic treatment, as well as superior vena cava compression syndrome;
- •After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy;
- •Combination of pure red cell anemia or gamma globulin;
- •Allergic to any medication component studied.
结局指标
主要结局
Toxicity Effect
时间窗: 8 Weeks
Toxicity effect defined as over CTCAE 4 grade 3 acute radiation toxicity of esophagitis 2 weeks after completion of 6 weeks of radiation therapy.
次要结局
- PFS(One month)
- OS(One month)
研究者
研究点 (1)
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