Study of NAC of GA Therapy for Patients With BRPC
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Interventions
- Registration Number
- NCT02926183
- Lead Sponsor
- Wakayama Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
-
Histologically or cytologically diagnosed as pancreatic adenocarcinoma, and consistent with NCCN guideline (Version 2. 2016) 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine plus nab-paclitaxel Neoadjuvant chemotherapy of 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.
- Primary Outcome Measures
Name Time Method Overall survival time from the first day of protocol therapy Up to 60 months
- Secondary Outcome Measures
Name Time Method 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 Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
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
Trial Locations
- Locations (18)
Osaka University
🇯🇵Suita, Osaka, Japan
Hirosaki University
🇯🇵Hirosaki, Aomori, Japan
Osaka Medical University
🇯🇵Takatsuki, Osaka, Japan
Hiroshima University
🇯🇵Hiroshima, Japan
Hyogo College of Medicine
🇯🇵Nishinomiya, Hyogo, Japan
Nagoya University
🇯🇵Nagoya, Aichi, Japan
Gifu University
🇯🇵Gifu, Japan
Kumamoto University
🇯🇵Kumamoto city, Japan
Kyoto University
🇯🇵Kyoto, Japan
Osaka City University
🇯🇵Osaka, Japan
Kobe University
🇯🇵Kobe, Hyogo, Japan
Kansai Medical University
🇯🇵Hirakata, Osaka, Japan
Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera
🇯🇵Wakayama, Japan
Nara Medical University
🇯🇵Kashihara, Nara, Japan
Kinki University
🇯🇵Sayama, Osaka, Japan
Chiba University
🇯🇵Chiba, Japan
Shiga Medical University
🇯🇵Ōtsu, Shiga, Japan