Phase 3 Study of Lobaplatin，5-Fluorouracil and Leucovorin for the Treatment of Recurrent or Metastatic Esophageal Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- objective response rate(ORR) time to progression (TTP) toxicities
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and the toxicity of lobaplatin, 5-fluorouracil (5-FU) and leucovorin in patients with esophageal carcinoma.
详细描述
patients with metastatic or recurrent esophageal cancer have a particularly poor prognosis .The overall 5-year survival rate for patients with newly diagnosed esophageal cancer is under 10%. Metastatic esophageal carcinoma is an incurable disease and due to the lack of effective therapies to manage this disease,the median survival is only 6 to 8 months Chemotherapy which is one of the most effective treatment so far is used as part of combined modality therapy for locally advanced diseases or as a palliative treatment for metastatic diseases.Lobaplatin is the third generation of platinum.Phase Ⅱclinical trials indicate that lobaplatin is effective for esophageal cancer, ovarian cancer, breast cancer and small cell lung cancer.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven squamous cell carcinoma of the esophagus(include cardiac cancer)
- •Newly diagnosed patients should be unable or unwilling to surgery
- •Recurrence after surgery must have no adjuvant chemotherapy or radiotherapy are allowed
- •Patients are required to have dimensionally measurable disease,with an objective measurable focus:preferably the use of spiral computed tomography(CT)and measurements of maximum diameter≥1cm.
- •Cooperative Oncology Group performance status 0-2 or KPS score ≥60,survival time ≥3 months
- •Neutrophils(ANC)≥1.5×109/L; blood platelets counts(BPC)≥80×109/L
- •Hemoglobin(Hgb)≥90g/L ,serum total bilirubin ≤1.0 times the upper normal limit(ULN): alanine aminotransferase and glutamic-oxalacetic transaminase (ALT and AST)≤2.5 ULN
- •Serum creatinine (Cr)≤1.5ULN
排除标准
- •pregnant or nursing women;
- •Female patients at child-bearing age, without taking effective contraceptive methods;
- •patients who have pathologic confirmation of other types of tumors (eg, leiomyosarcoma, malignant lymphoma) rather than esophageal cancer;
- •patients with tumors other than esophageal cancer ,except cervical carcinoma in situ and skin basal cancer or squamous cell carcinoma received adequate treatment;
- •patients with cerebral or meningeal metastasis, intestinal obstruction, or symptomatic pathologic changes of peripheral nerve,NCIC-CTG standard >grade 2
- •patients with serious complications such as: serious heart disease remained unstable after treatment, or myocardial infarction, congestive heart failure, unstable angina, frank pericardial effusion or unstable arrhythmias in 6 months before being enrolled into the group; confirmed neuropathy or psychosis, including dementia or epilepsia; uncontrolled infection;active disseminated intravascular coagulation;uncontrolled diabetes, fasting serum glucose> 7.8mmol / L
研究组 & 干预措施
Esophageal Carcinoma
干预措施: lobaplatin , 5-FU ,leucovorin (Drug)
结局指标
主要结局
objective response rate(ORR) time to progression (TTP) toxicities
时间窗: 12/31/2010
次要结局
- 1-year survival rate KPS score(12/31/2009)