Phase I Study of Neoadjuvant Chemotherapy of Gemcitabine Plus Nab-paclitaxel for Patients With Borderline Resectable Pancreatic Cancer.
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of participants with toxicity of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
研究概览
简要总结
Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen.
详细描述
Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. GEMABR is one of the high response rate treatment regimen, the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and peripheral neuropathy were significantly higher in the g group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen. The investigators also evaluate the optimal treatment schedule of NAC-GEMABR therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, R0 resection rate, and resection rate for borderline resectable pancreatic 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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven invasive pancreatic ductal carcinoma
- •Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)
- •Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma
- •Patients indicated distal pancreatectomy with en bloc celiac axis resection
- •PS (ECOG) 0-1
- •≧20 years old and < 80 years old
- •First line treatment
- •The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count ≦12,000/mm3 Neutrophil count ≧1,500/mm3 Platelet count ≧100,000mm3 Total bilirubin <2.0mg/dL Serum Creatinine ≦upper limits of normal(ULN) AST, ALT≦2.5×ULN Albumin≧3.0g/dL Hemoglobin≧9.0g/dL
- •Written informed consent to participate in this study
排除标准
- •Severe drug hypersensitivity
- •Multiple primary cancers within 5 years
- •Severe infection
- •With grade2 or more severe peripheral neuropathy
- •With intestinal paralysys, ileus
- •Interstitial pneumonia or pulmonary
- •With uncontrollable pleural effusion or ascites
- •Receiving atazanavir sulfate
- •With uncontrollable diabetes
- •With uncontrollable heart failure, angina, hypertension, arrhythmia
- •With severe psychological symptoms
- •With watery diarrhea
- •Pregnant or lactating women, or women with known or suspected pregnancy
- •Inappropriate patients for entry on this study in the judgment of the investigator
研究组 & 干预措施
NAC-GEMABR
Neoadjuvant chemotherapy 2 courses of NAC-GEMABR for subsequent 10 patients.
干预措施: NAC-GEMABR (Drug)
结局指标
主要结局
Number of participants with toxicity of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
时间窗: Up to 30 weeks.
Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
次要结局
- The resection rate of NAC-GEMABR therapy as neoadjuvant chemothterapy for borderline resectable pancreatic cancer.(Up to 24 weeks)
- The R0 resection rate of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.(Up to 30 weeks)
研究者
Hiroki Yamaue
Dean & Professor of the second department of surgery
Wakayama Medical University