Study of NAC of GA Therapy for Patients With BRPC

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02926183
• Other study ID #: 1881
• Status: Recruiting
• Phase: Phase 2
• Start date: October 2016
• Est. completion date: September 2021

Study information

• Verified date: October 2019
• Source: Wakayama Medical University
• Contact: Ken-ichi Okada, M.D., Ph.D.
• Phone: +81-73-441-0613
• Email: okada[@]wakayama-med.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Intervention

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.

Locations

Country	Name	City	State
Japan	Chiba University	Chiba
Japan	Gifu University	Gifu
Japan	Kansai Medical University	Hirakata	Osaka
Japan	Hirosaki University	Hirosaki	Aomori
Japan	Hiroshima University	Hiroshima
Japan	Nara Medical University	Kashihara	Nara
Japan	Kobe University	Kobe	Hyogo
Japan	Kumamoto University	Kumamoto city
Japan	Kyoto Prefectural University of Medicine	Kyoto
Japan	Kyoto University	Kyoto
Japan	Nagoya University	Nagoya, Aichi
Japan	Hyogo College of Medicine	Nishinomiya	Hyogo
Japan	Osaka City University	Osaka
Japan	Shiga Medical University	Otsu	Shiga
Japan	Kinki University	Sayama	Osaka
Japan	Osaka University	Suita	Osaka
Japan	Osaka Medical University	Takatsuki	Osaka
Japan	Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera	Wakayama

Sponsors (1)

Lead Sponsor	Collaborator
Wakayama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

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