Study of NAC of GA Therapy for Patients With BRPC

NCT02926183 | Unknown Phase 2 DMC

• 1 other identifier: 1881
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival time from the first day of protocol therapy

  Up to 60 months

Secondary Outcomes (11)

• Recurrence free survival from the first day of protocol therapy

  Up to 60 months

• Adverse effect

  Up to 30 weeks

• Morbidity based on Clavien Dindo classification of more than Grade3

  Up to 30 weeks

• Response rate

  Up to 12 weeks

• Chemotherapeutic effect grade based on Evans classification

  Up to 12 weeks

Study Arms (1)

Gemcitabine plus nab-paclitaxel

EXPERIMENTAL

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

Interventions

Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel DRUG

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.

Also known as: NAC-GA for BRPC

Gemcitabine plus nab-paclitaxel

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wakayama Medical University: lead

Study Sites (18)

Hirosaki University

Hirosaki, Aomori, Japan

NOT YET RECRUITING

Kobe University

Kobe, Hyōgo, Japan

NOT YET RECRUITING

Hyogo College of Medicine

Nishinomiya, Hyōgo, Japan

NOT YET RECRUITING

Nara Medical University

Kashihara, Nara, Japan

NOT YET RECRUITING

Kansai Medical University

Hirakata, Osaka, Japan

NOT YET RECRUITING

Kinki University

Sayama, Osaka, Japan

NOT YET RECRUITING

Osaka University

Suita, Osaka, Japan

NOT YET RECRUITING

Osaka Medical University

Takatsuki, Osaka, Japan

NOT YET RECRUITING

Shiga Medical University

Ōtsu, Shiga, Japan

NOT YET RECRUITING

Chiba University

Chiba, Japan

NOT YET RECRUITING

Gifu University

Gifu, Japan

NOT YET RECRUITING

Hiroshima University

Hiroshima, Japan

NOT YET RECRUITING

Kumamoto University

Kumamoto, Japan

NOT YET RECRUITING

Kyoto Prefectural University of Medicine

Kyoto, Japan

NOT YET RECRUITING

Kyoto University

Kyoto, Japan

NOT YET RECRUITING

Nagoya University

Nagoya, Aichi, Japan

NOT YET RECRUITING

Osaka City University

Osaka, Japan

NOT YET RECRUITING

Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera

Wakayama, 641-8510, Japan

RECRUITING

Related Publications (1)

• Okada KI, Kimura K, Yamashita YI, Shibuya K, Matsumoto I, Satoi S, Yoshida K, Kodera Y, Akahori T, Hirono S, Eguchi H, Asakuma M, Tani M, Hatano E, Ikoma H, Ohira G, Hayashi H, Wan K, Shimokawa T, Kawai M, Yamaue H; NAC-GA investigators. Efficacy and safety of neoadjuvant nab-paclitaxel plus gemcitabine therapy in patients with borderline resectable pancreatic cancer: A multicenter single-arm phase II study (NAC-GA trial). Ann Gastroenterol Surg. 2023 Jul 8;7(6):997-1008. doi: 10.1002/ags3.12712. eCollection 2023 Nov.

  PMID: 37927936 DERIVED

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NAC-GA investigator

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 6, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (18)