Study of NAC of GA Therapy for Patients With BRPC

Wakayama Medical University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Ductal Adenocarcinoma

Interventions

Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxelDRUG

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

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)

Locations (18)

Hirosaki University

Hirosaki, Aomori, Japan

NOT_YET_RECRUITING

Kobe University

Kobe, Hyōgo, Japan

Outcomes

Primary Outcomes

Overall survival time from the first day of protocol therapy

Time frame: Up to 60 months

Secondary Outcomes

Recurrence free survival from the first day of protocol therapy

Time frame: Up to 60 months

Adverse effect

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

Time frame: Up to 30 weeks

Morbidity based on Clavien Dindo classification of more than Grade3

Time frame: Up to 30 weeks

Response rate

Time frame: Up to 12 weeks

Chemotherapeutic effect grade based on Evans classification

Time frame: Up to 12 weeks

Resection rate

Time frame: Up to 30 weeks

R0 resection rate

Time frame: Up to 30 weeks

Intraoperative blood loss

Time frame: Up to 30 weeks

The overall morbidity rates based on Clavien Dindo classification

Time frame: Up to 50 weeks

Number of patient rate in postoperative adjuvant therapy

Time frame: Up to 30 weeks

Central Contacts

Ken-ichi Okada, M.D., Ph.D.

CONTACT

+81-73-441-0613 okada@wakayama-med.ac.jp

Data from ClinicalTrials.gov

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