Study of NAC of GA Therapy for Patients With BRPC

  • STATUS
    Recruiting
  • days left to enroll
    51
  • participants needed
    60
  • sponsor
    Wakayama Medical University
Updated on 24 January 2021
paclitaxel
cancer
measurable disease
neutrophil count
pancreatic adenocarcinoma
gemcitabine
metastatic pancreatic cancer

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.

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.

Details
Condition Pancreatic Ductal Adenocarcinoma
Treatment Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel
Clinical Study IdentifierNCT02926183
SponsorWakayama Medical University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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)
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