Study of NAC of GA Therapy for Patients With BRPC

October 2, 2019 updated by: Hiroki Yamaue, Wakayama Medical University

Phase II Study of Neoadjuvant Chemotherapy of Gemcitabine+Nab-paclitaxel Therapy for Patients With Borderline Resectable Pancreatic Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Chiba, Japan
        • Not yet recruiting
        • Chiba University
        • Contact:
          • Hideyuki Yoshitomi, M.D., Ph.D.
      • Gifu, Japan
        • Not yet recruiting
        • Gifu University
        • Contact:
          • Kazuhiro Yoshida, M.D., Ph.D.
      • Hiroshima, Japan
        • Not yet recruiting
        • Hiroshima University
        • Contact:
          • Yoshiaki Murakami, M.D., PhD.
      • Kumamoto city, Japan
        • Not yet recruiting
        • Kumamoto University
        • Contact:
          • Daisuke Hashimoto, M.D., Ph.D.
      • Kyoto, Japan
        • Not yet recruiting
        • Kyoto Prefectural University of Medicine
        • Contact:
          • Hisashi Ikoma, M.D., PhD
      • Kyoto, Japan
        • Not yet recruiting
        • Kyoto University
        • Contact:
          • Toshihiko Masui, M.D., Ph.D.
      • Nagoya, Aichi, Japan
        • Not yet recruiting
        • Nagoya University
        • Contact:
          • Tsutomu Fujii, M.D., PhD.
      • Osaka, Japan
        • Not yet recruiting
        • Osaka City University
        • Contact:
          • Ryosuke Amano, M.D., PhD.
        • Sub-Investigator:
          • Ryosuke Amano, M.D., PhD.
      • Wakayama, Japan, 641-8510
        • Recruiting
        • Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera
        • Contact:
        • Principal Investigator:
          • Hiroki Yamaue, M.D., Ph.D.
    • Aomori
      • Hirosaki, Aomori, Japan
        • Not yet recruiting
        • Hirosaki University
        • Contact:
          • Keinosuke Ishido, M.D., Ph.D.
    • Hyogo
      • Kobe, Hyogo, Japan
        • Not yet recruiting
        • Kobe University
        • Contact:
          • Hirochika Toyama, M.D., PhD.
      • Nishinomiya, Hyogo, Japan
        • Not yet recruiting
        • Hyogo College of Medicine
        • Contact:
          • Jiro Fujimoto, M.D., PhD.
        • Sub-Investigator:
          • Kazuhiro Suzumura, M.D., PhD.
    • Nara
      • Kashihara, Nara, Japan
        • Not yet recruiting
        • Nara Medical University
        • Contact:
          • Masayuki Sho, M.D., PhD.
    • Osaka
      • Hirakata, Osaka, Japan
        • Not yet recruiting
        • Kansai Medical University
        • Contact:
          • Sohei Satoi, M.D., PhD
      • Sayama, Osaka, Japan
        • Not yet recruiting
        • Kinki University
        • Contact:
          • Ippei Matsumoto, M.D., PhD
      • Suita, Osaka, Japan
        • Not yet recruiting
        • Osaka University
        • Contact:
          • Hidetoshi Eguchi, M.D., Ph.D.
      • Takatsuki, Osaka, Japan
        • Not yet recruiting
        • Osaka Medical University
        • Contact:
          • Mitsuhiro Asakuma, M.D., Ph.D.
    • Shiga
      • Ōtsu, Shiga, Japan
        • Not yet recruiting
        • Shiga Medical University
        • Contact:
          • Masaji Tani, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • NAC-GA for BRPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival time from the first day of protocol therapy
Time Frame: Up to 60 months
Up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival from the first day of protocol therapy
Time Frame: Up to 60 months
Up to 60 months
Adverse effect
Time Frame: Up to 30 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Up to 30 weeks
Morbidity based on Clavien Dindo classification of more than Grade3
Time Frame: Up to 30 weeks
Up to 30 weeks
Response rate
Time Frame: Up to 12 weeks
Up to 12 weeks
Chemotherapeutic effect grade based on Evans classification
Time Frame: Up to 12 weeks
Up to 12 weeks
Resection rate
Time Frame: Up to 30 weeks
Up to 30 weeks
R0 resection rate
Time Frame: Up to 30 weeks
Up to 30 weeks
Intraoperative blood loss
Time Frame: Up to 30 weeks
Up to 30 weeks
The overall morbidity rates based on Clavien Dindo classification
Time Frame: Up to 50 weeks
Up to 50 weeks
Number of patient rate in postoperative adjuvant therapy
Time Frame: Up to 30 weeks
Up to 30 weeks
Dose intensity
Time Frame: Up to 12 weeks
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wakayama Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1881

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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