Overall survival after neoadjuvant therapy and surgery for Borderline resectable pancreatic carcinoma (BRPC) is recognized as a goal for a multidisciplinary approach.
Objective: The NAC-GA trial was a prospective multicenter phase II trial and its implementation was planned for patients with BRPC defined as borderline by the National Comprehensive Cancer Network (Version 2.2016) to investigate improvement of overall survival after the first day of initial therapy. Endpoints: This clinical trial primarily evaluated the primary endpoint of overall survival time from the first day of protocol therapy. The secondary endpoints were recurrence-free survival from the first day of protocol therapy, safety of the protocol therapy (adverse effects), morbidity, response rate, disease control rate, preoperative/postoperative tumor marker (CA19-9, CEA), rate of normalization, reduction rate of SUVmax value on PET-CT, chemotherapeutic effect, resection rate, R0 resection rate, surgical data, overall morbidity rates, rate of patient undergo postoperative adjuvant therapy, dose intensity, quality of life regarding fatigue and malaise assessed by the questionnaire of FACIT-F, and peripheral sensory neuropathy (PSN) assessed by the questionnaire of FACT/GOG-NTX subscale (Version 4) and Patient Neurotoxicity Questionnaire (PNQ). Sixty patients were included in the study. Treatment Methods: 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 days 1, 8 and 15 over a four-week period as one cycle of regimen. Even if the dose on day 8 was missed, the next dose was still administered on day 8 of the same cycle as originally scheduled. All patients were given one week of rest between two cycles. This regimen was repeated twice. In the absence of disease progression, patients would undergo planned pancreatectomy within eight weeks. Postoperative adjuvant therapy was unregulated in this study.
Clinical trial identification
UMIN Clinical Trials Registry (UMIN000024154) - ClinicalTrials.gov (NCT02926183)
Legal entity responsible for the study
Wakayama Medical University
Research fund was provided to the Wakayama Medical University by Taiho Pharmaceutical Co., Ltd, Tokyo, Japan under a research agreement.
K-I. Okada: Honoraria and research funding from Taiho Pharmaceutical Co. Ltd., Tokyo, Japan. T. Shimokawa, S. Hirono, M. Kawai, M. Miyazawa, Y. Kitahata: Research fund to Wakayama Medical University by Taiho Pharmaceutical Co., Ltd, Tokyo, Japan under a research agreement. H. Yamaue: Honoraria and research funding from Taiho Pharmaceutical Co. Ltd., Tokyo, Japan. Research fund to Wakayama Medical University by Taiho Pharmaceutical Co., Ltd, Tokyo, Japan under a research agreement.