A Multicenter Phase II Trial of Preoperative Chemotherapy With Gemcitabine/ Cisplatin /S-1 (GCS) for Biliary Tract Cancers With Lymph Node Metastasis Diagnosed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Curative resection rate
研究概览
简要总结
To evaluate the efficacy and the safety of preoperative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis by FDG-PET.
详细描述
Biliary tract cancer is one of the most lethal malignancies worldwide, with surgery representing the only potentially curative treatment for this disease. However, many patients are diagnosed as far advanced stage, which is too late for curative resection, and even if surgery can be performed, the likelihood of relapse is very high. Lymph node metastasis is the most powerful prognostic factor in biliary tract cancer, which makes accurate preoperative assessment of lymph node metastasis important for indication of resection. However, the diagnostic accuracy, sensitivity, and specificity of conventional imaging techniques, including computed tomography (CT) and magnetic resonance imaging (MRI), seem to be insufficient for accurate detection of lymph node metastasis. Previously, the investigators reported FDG-PET is useful for prediction of lymph node metastasis.
On the other hand, gemcitabine has been widely used to treat the patients with unresectable or recurrent biliary tract cancer. In the Advanced Biliary tract Cancer (ABC)-02 study, the first prospective multicenter phase III study in this field, the combination of gemcitabine/cisplatin was compared with gemcitabine monotherapy and found that the combination regimen significantly prolonged Median Survival Time (MST) (from 8.1 to 11.7 months; P < 0.001). Gemcitabine/cisplatin combination therapy is now considered to be the standard regimen for advanced biliary tract cancer. S-1 is an oral fluoropyrimidine prodrug that has confirmed efficacy against various solid tumors, both alone and in combination with other cytotoxic drugs. S-1 monotherapy has yielded good results against advanced biliary tract cancer and gemcitabine/S-1 combination therapy has yielded promising results with acceptable toxicity levels for patients with advanced biliary tract cancer.
Furthermore, the investigators reported the safety and efficacy of adding S-1 to gemcitabine/cisplatin combination regimen (GCS) for advanced biliary tract cancer.
In this study, the investigators evaluate the efficacy and the safety of preoperative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis by FDG-PET
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with radiologically proven biliary tract cancer.
- •No extra-hepatic disease.
- •No prior therapy.
- •The function of the liver is kept as satisfied after hepatectomy.
- •No chronic liver damage.
- •Patients of age over 20 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Sufficient organ function (neutrophil count >=1,500/mm3 and platelet count >=100,000/mm3, Hemoglobin >=9.0g/dL, Aspartate transaminase (AST)/alanine aminotransferase (ALT) <=150 IU/L, total bilirubin <=1.5 mg/dL , creatinine <=1.2 mg/dL , creatinine clearance >=60 mL/min) 9.Patients obtained written informed consent.
排除标准
- •Massive abdominal effusion requiring treatment.
- •Active concomitant malignancy.
- •The case suspected of infection.
- •Patients with water solubility diarrhea.
- •Mental disease or psychotic manifestation.
- •Under continuous steroid therapy.
- •Patients with acute myocardial infarction.
- •Patients with severe complications.
- •Pregnancy or the desire to preserve fecundity.
- •Serious drug hypersensitivity or a history of drug allergy.
- •Any patients judged by the investigator to be unfit to participate in the study.
研究组 & 干预措施
Gemcitabine, Cisplatin, S-1
1000mg/m2/day1, 25mg/m2/day1, 100mg/body/day1-7
干预措施: Gemcitabine, Cisplatin, S-1 (Drug)
结局指标
主要结局
Curative resection rate
时间窗: 14weeks
The primary endpoint is designated to evaluate curative resection rate after preoperative chemotherapy with GCS for Biliary Tract Cancers with lymph node metastasis diagnosed by FDG-PET.
次要结局
- Response rate and toxicity(10 weeks)