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切除可能境界膵癌に対する術前FIRINOX療法-パイロット研究

基本情報

NCT ID
NCT02148549
ステータス
完了
試験のフェーズ
第1相
試験タイプ
介入
目標被験者数
10
治験依頼者名
Wakayama Medical University

概要

FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX 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 diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen

対象疾患

Patients With Borderline Resectable Pancreatic Cancer

介入

FIRINOX(DRUG)

依頼者(Sponsor)

実施施設 (8)

Kansai Medical University

Hirakata, Osaka, Japan

和歌山県立医科大学附属病院

Wakayama, Japan

Nara Prefectual Medical University

Kashihara, Nara, Japan

日本赤十字社愛知医療センター名古屋第二病院

Nagoya, Aichi-ken, Japan

地方独立行政法人 大阪府立病院機構 大阪国際がんセンター

Osaka, Japan

広島大学病院

Hiroshima, Japan

Kobe University

Kobe, Hyōgo, Japan

大阪大学医学部附属病院

Suita, Osaka, Japan