Clinical trial NCT02926183: Study of NAC of GA Therapy for Patients With BRPC
Official title: Phase II Study of Neoadjuvant Chemotherapy of Gemcitabine+Nab-paclitaxel Therapy for Patients With Borderline Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Ductal Adenocarcinoma
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically diagnosed as pancreatic adenocarcinoma, and consistent with NCCN guideline (Version 2. 2016) borderline resectable-arterial, borderline resectable-venous
2. Case with measurable lesion
3. First line treatment
4. PS (ECOG) 0-1
5. \>= 20 years old and \<80 years old
6. 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
7. Written informed consent to participate in this study

Exclusion Criteria:

1. Severe drug hypersensitivity
2. Multiple primary cancers within 5 years
3. Severe infection
4. With grade2 or more severe peripheral neuropathy
5. Interstitial pneumonia or pulmonary fibrosis
6. With uncontrollable pleural effusion or ascites
7. With uncontrollable diabetes mellitus
8. With uncontrollable heart failure, angina, hypertension, arrhythmia
9. With severe neurological/psychological symptoms
10. With watery diarrhea
11. Pregnant or lactating women or women with unknown or suspected pregnancy
12. Inappropriate patients for entry on this study in the judgement of the investigator
13. Diagnosed as Resectable/Unresectable pancreatic carcinoma on NCCN guideline (Version 2.2016)

Primary outcomes:
measure: Overall survival time from the first day of protocol therapy
timeFrame: Up to 60 months
Secondary outcomes:
measure: Recurrence free survival from the first day of protocol therapy
timeFrame: Up to 60 months
measure: Adverse effect
timeFrame: Up to 30 weeks
measure: Morbidity based on Clavien Dindo classification of more than Grade3
timeFrame: Up to 30 weeks
measure: Response rate
timeFrame: Up to 12 weeks
measure: Chemotherapeutic effect grade based on Evans classification
timeFrame: Up to 12 weeks
measure: Resection rate
timeFrame: Up to 30 weeks
measure: R0 resection rate
timeFrame: Up to 30 weeks
measure: Intraoperative blood loss
timeFrame: Up to 30 weeks
measure: The overall morbidity rates based on Clavien Dindo classification
timeFrame: Up to 50 weeks
measure: Number of patient rate in postoperative adjuvant therapy
timeFrame: Up to 30 weeks
measure: Dose intensity
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Hirosaki
country: Japan
facility: Hirosaki University
state: Aomori
city: Kobe
country: Japan
facility: Kobe University
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Kashihara
country: Japan
facility: Nara Medical University
state: Nara
city: Hirakata
country: Japan
facility: Kansai Medical University
state: Osaka
city: Sayama
country: Japan
facility: Kinki University
state: Osaka
city: Suita
country: Japan
facility: Osaka University
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical University
state: Osaka
city: Ōtsu
country: Japan
facility: Shiga Medical University
state: Shiga
city: Chiba
country: Japan
facility: Chiba University
city: Gifu
country: Japan
facility: Gifu University
city: Hiroshima
country: Japan
facility: Hiroshima University
city: Kumamoto city
country: Japan
facility: Kumamoto University
city: Kyoto
country: Japan
facility: Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Kyoto University
city: Nagoya, Aichi
country: Japan
facility: Nagoya University
city: Osaka
country: Japan
facility: Osaka City University
city: Wakayama
country: Japan
facility: Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera
Study officials:
References: