A Perspective Trial of Sodium Glycididazole Combined With Preoperatie Concurrent Chemoradiotherapy for Locally Advanced Squamous Cell Esophageal Carcinoma
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 9
- 主要终点
- pathologic Complete Response
研究概览
简要总结
This is a perspective, multicenter,single arm, open label study to evaluate the efficacy and safety of treatment with CMNa combined with preoperatie concurrent chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma . Analyses of primary objective (pathologic Complete Response) will be done as defined in the protocol.
详细描述
The primary end ponit of this study is pathological complete response.And the primary hypothesis is the CMNa will improve patholofical response rate and thus improve OS、DFS. Assuming bilateral a=0.05, statistical power of 80%.The total sample size is 40 cases.
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
- •Signed written informed consent prior to study entry
- •Patients with ESCC in thoracic segment which is resectable（T2-3，N0-1，M0） confirmed by imaging and pathology or cytology;
- •Patients have tumor lesions which can be objectively measured ,the length of tumor:≤8cm, the width of tumor:≤5cm;If the tumor cross the GEJ and violate the proximal stomach, the tumor must include esophagus and GEJ. The tumor is less than 2cm of the stomach
- •Not infringe bronchial wall; no esophagus-tracheal fistula.
- •normal bone marrow reserve: ANCcount ≥1500/mm3;platelet count ≥100,000/mm3,hemoglobin≥9g/dl
- •normal hepatic funcion:bilirubin level ≤1.5×ULN;AST/ALT≤1.5×ULN
- •normal renal function: serum creatinine≤1.5mg/dl and calculated creatinine clearance ≥60ml/min
- •normal cardiac function
- •ECOG PS of 0 or 1
- •Expected lifetime≥3 months
- •Subjects tumor tissue available for the relevant biomarker detection
排除标准
- •Female subject who is during pregnancy or lactation, and the subject who have fertility don't take effective contraception during study.
- •Any mental illness or nervous system lesions or can't tell treatment response clearly (such as cerebrovascular accident sequelae)
- •Any serious uncontrolled disease and infection, such as severe heart, liver, kidney diseases or diabetes, can't complete the treatment plan
- •Patients who have other malignant lesions, except curable skin cancer (non- melanoma skin cancer),carcinoma in situ of cervix or serve disease cured for 5 years
- •Primary lesions were multifocal
- •Patients with distant metastasis. A small amount of stomach tumor violate GEJ or the distal esophageal.
- •Patients who have obvious esophageal ulcers or have above moderate pains in chest-back or have symptoms of esophageal perforation
- •received anti-cancer treatment of esophageal cancer before the group, including surgery, radiotherapy, chemotherapy (induction of chemotherapy before the group is greater than or equal to two cycles).
- •Cervical esophageal cancer confirmed by iconography
- •Not esophageal squamous carcinoma confirmed by pathology or cytology
- •History of active hepatitis
研究组 & 干预措施
Sodium Glycididazole
Sodium Glycididazole：800mg/m2，finished in 30 minutes,within 60 minutes after intravenous drip for radiation therapy.Three times a week (once every other one day),before radiation therapy. Chemotherapy Paclitaxel:45 mg/m²,d1,week 1-4 Cisplatin:20 mg/m²,d1,week 1-4 OR Docetaxel: 75 mg / m², 1 day or divided into D1, D8 days, 21 days / cycle. Cisplatin: 75 mg / m², divided into D1-D3 days or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle.
OR 5-FU: 500 mg / m² / day, divided into D1 ~ D5 for use, 21 days / cycle. Cisplatin: 75 mg / m² / day, divided into D1-D3 day or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle 3DCRT/IMRT:2.0Gy/f/day,T40Gy/20f,week 1-4
干预措施: Sodium Glycididazole (Drug)
结局指标
主要结局
pathologic Complete Response
时间窗: 1 months
TRG-cited from Mandard AM, Dalibard F, Mandard JC, Marnay J, Henry-Amar M, Petiot JF, Roussel A, Jacob JH, Segol P, Samama G, Pathologic assessment of tumor regression after preoperative chemoradiotherapy of esophageal carcinoma. Cancer, 73, 2680-2686, 1994.
次要结局
- Disease-Free Survival(36 months)
- Overall Survival(36 months)
研究者
Jinming Yu
president
Shandong Cancer Hospital and Institute