Phase II Study of Neoadjuvant Chemotherapy of Gemcitabine+Nab-paclitaxel Therapy for Patients With Borderline Resectable Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 18
- 主要终点
- Overall survival time from the first day of protocol therapy
研究概览
简要总结
Gemcitabine plus nub-paclitaxel (GA) 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 on survival time as a preoperative chemotherapy, the investigators use the NAC-GA regimen includes only two cycles (three times weekly and one week rest) of GA regimen.
详细描述
Gemcitabine plus nub-paclitaxel (GA) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. GA 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 on survival time as a preoperative chemotherapy, the investigators use the NAC-GA regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen. The investigators also evaluate Recurrence free survival from the first day of protocol therapy, safety of the protocol therapy(Adverse effect), morbidity based on Clavien Dindo classification of more than Grade 3, response rate, preoperative/postoperative tumor marker (CA19-9, CEA), rate of mornalization, reduction rate of SUVmax value on PET-CT (limited only for PET-CT available institutions), chemotherapeutic effect grade based on Evans classification, resection rate, R0 resection rate, surgical data (operative time, blood loss, transfusion, postoperative hospital day), the overall morbidity rates (Reoperation, rate of re-admission, mortality), number of patient rate in postoperative adjuvant therapy (entry rate, completion rate), dose intensity 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
- •Histologically or cytologically diagnosed as pancreatic adenocarcinoma, and consistent with NCCN guideline (Version
- •borderline resectable-arterial, borderline resectable-venous
- •Case with measurable lesion
- •First line treatment
- •PS (ECOG) 0-1
- •>= 20 years old and <80 years old
- •The following criteria must be satisfied in laboratory tests within 14 days of registration
- •WBC count<=12,000/mm3
- •Neutrophil count>=1,500/mm3
- •Hb >= 9.0g/dl
- •Plt >= 100,000/mm3
- •T.Bil <2.0mg/dl (<3=.0mg/dl in biliary drainage case)
- •Serum Cr<=upper limits of normal (ULN)
- •AST, ALT <= 2.5xULN
- •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
- •Interstitial pneumonia or pulmonary fibrosis
- •With uncontrollable pleural effusion or ascites
- •With uncontrollable diabetes mellitus
- •With uncontrollable heart failure, angina, hypertension, arrhythmia
- •With severe neurological/psychological symptoms
- •With watery diarrhea
- •Pregnant or lactating women or women with unknown or suspected pregnancy
- •Inappropriate patients for entry on this study in the judgement of the investigator
- •Diagnosed as Resectable/Unresectable pancreatic carcinoma on NCCN guideline (Version 2.2016)
研究组 & 干预措施
Gemcitabine plus nab-paclitaxel
Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel: Enrolled patients were administered a 30-min intravenous infusion of nab-paclitaxel at a dose of 125 mg/m2, followed by a 30-min intravenous infusion of gemcitabine at a dose of 1000 mg/m2, on day 1, 8, and 15 evey 4 weeks as one cycle of regimen.
干预措施: Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel (Drug)
结局指标
主要结局
Overall survival time from the first day of protocol therapy
时间窗: Up to 60 months
次要结局
- Morbidity based on Clavien Dindo classification of more than Grade3(Up to 30 weeks)
- Response rate(Up to 12 weeks)
- Resection rate(Up to 30 weeks)
- The overall morbidity rates based on Clavien Dindo classification(Up to 50 weeks)
- Number of patient rate in postoperative adjuvant therapy(Up to 30 weeks)
- Recurrence free survival from the first day of protocol therapy(Up to 60 months)
- Adverse effect(Up to 30 weeks)
- Dose intensity(Up to 12 weeks)
- R0 resection rate(Up to 30 weeks)
- Chemotherapeutic effect grade based on Evans classification(Up to 12 weeks)
- Intraoperative blood loss(Up to 30 weeks)
研究者
Hiroki Yamaue
NAC-GA investigator
Wakayama Medical University