Furukawa, Toru    Department   School of Medicine(Tokyo Women's Medical University Hospital), School of Medicine    Position   Visiting Professor
Language	English
Title	Randomized phase II/III trial of neoadjuvant chemotherapy with gemcitabine and S-1 versussurgery-first for resectable pancreatic carcer (Prep-02/JSAP05).
Conference	The 2015 Annual Meeting of the American Society of Clinical Oncology
Promoters	American Society of Clinical Oncology
Conference Type	International society and overseas society
Presentation Type	Poster notice
Lecture Type	General
Publisher and common publisher	Michiaki Unno◎, Fuyuhiko Motoi, Tomoo Kosuge, Hideki Ueno, Hiroki Yamaue, Sohei Satoi, Masayuki Sho, Goro, Honda, Ippei Matsumoto, Keita Wada, Junji Furuse, Toru Furukawa, Kazuyuki Ishida, Kei Takase, Yutaka, Matsuyama, Kei Nakagawa, Yu Katayose.
Date	2015/05/29
Venue (city and name of the country)	Chicago, IL, U S A
Society abstract	Journal of Clinical Oncology 33(suppl.),TPS4151 2015
Summary	Background: Despite the improvements in the surgery and postoperative adjuvant therapy for resected pancreatic adenocarcinoma (PDAC), its prognosis remains poor. Surgery-first and adjuvant increases survival for resected PDAC, but this strategy cannot be offered to a significant proportion of patients due to the unresectable cases found at laparotomy or postoperative morbidity. Neoadjuvant chemotherapy (NAC) with gemcitabine (GEM) and S1 is safe and effective strategy and has been reported 45.7% of 2-year survival rate in an intention-to-treat analysis. Methods: This is a prospective randomized phase II/III trial. Patients who planned resection with cytologically or histologically proven PDAC are eligible for this study. All patients must be at least 20 and under 80 years old with written informed consent. Abutment of major visceral arteries on radiological finding is considered exclusion criteria. Eligible patients will be randomized to surgery followed by adjuvant S1 (80 mg/m2/day for four weeks, repeated similarly every six weeks for a total of four courses) for 6 months or NAC (GEM 1000 mg/m2/week, S1 80 mg/m2/day) followed by surgery and the same adjuvant treatment. NAC is given a total of 4 doses of GEM and 4 weeks of S1 within 8 weeks. The primary study endpoint is resection rate for phase II (n = 80) and overall survival for phase III (n = 280). The secondary endpoints are adverse events and response of NAC, and recurrence-free survival. According to the sample size calculation, 180 patients in total need to be randomized to each treatment arm. For quality control, radiological staging and resected specimen will be centrally reviewed by dedicated radiologists and pathologists, respectively. In phase II part, no more than 14 cases of non-resection (90%CI: 22.6%- 49.2%) in each arm (n = 40) is required to transit from phase II to phase III. Enrollment to cohort began in January 2013. Discussion:The Prep-02/JSAP05 study will provide the unbiased overall survival of all PDAC patients who were planned resection. Furthermore, this trial will determine the efficacy of NAC in PDAC and offers a potential for translational research. Clinical trial information: UMIN000009634.