Study of NAC of GA Therapy for Patients With BRPC

Wakayama Medical University

Status and phase: Unknown; Phase 2

Conditions: Pancreatic Ductal Adenocarcinoma

Treatments: Drug: Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT02926183

1881

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Gemcitabine plus nab-paclitaxel

Experimental group

Description:

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.

Treatment:

Drug: Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel