フルカワ　トオル   Furukawa Tooru   古川　徹    所属   医学部 医学科（東京女子医科大学病院）    職種   客員教授
言語種別	英語
発表タイトル	Randomized phase II/III trial of neoadjuvant chemotherapy with gemcitabine and S-1 versussurgery-first for resectable pancreatic carcer (Prep-02/JSAP05).
会議名	The 2015 Annual Meeting of the American Society of Clinical Oncology
主催者	American Society of Clinical Oncology
学会区分	国際学会及び海外の学会
発表形式	ポスター掲示
講演区分	一般
発表者・共同発表者	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.
発表年月日	2015/05/29
開催地 （都市, 国名）	Chicago, IL, U S A
学会抄録	Journal of Clinical Oncology 33(suppl.),TPS4151 2015
概要	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.