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ID 32412
file
title alternative
A Multiinstitutional Feasibility Study of Trimodality Therapy for Resectable Malignant Mesothelioma
creator
Tanaka, Fumihiro
Hasegawa, Seiki
Yamanaka, Takeharu
Fukuoka, Kazuya
Soejima, Toshinori
Kamikonya, Norihiko
Tsujimura, Tohru
Nakano, Takashi
subject
悪性胸膜中皮腫
集学的治療
ペメトレキセド
胸膜肺全摘除術
片側全胸郭照射
Malignant pleural mesothelioma
Trimodality therapy
Pemetrexed
Extrapleural pneumonectomy
Hemithoracic radiation
NDC
Medical sciences
abstract
目的.切除可能悪性胸膜中皮腫の手術成績向上のためには集学的治療が必要であるが,その至適治療法は確立していない.術前化学療法,手術および術後放射線治療からなる集学的治療のコンプライアンスと安全性を検証するために前向き臨床試験立案を計画した.研究計画.文部科学省科学技術振興調整費"アスベスト関連疾患への総括的取り組み"の一環として,臨床試験が計画された.結果.多施設共同のfeasibility試験が承認され,現在開始された.適格症例は,シスプラチンとペメトレキセドによる化学療法を3コース行った後に胸膜肺全摘除術と術後の放射線治療により治療される.主要評価項目は完全切除率と治療関連死亡率であり,向こう3年間で40例の適格症例の本臨床試験への参加が期待されている.結論.本臨床試験の完遂により切除可能胸膜中皮腫に対する集学的治療のfeasibilityが確認されれば,引き続いて臨床的有効性を検証する第II相試験へ進む予定である.
abstract
Objective. Multimodality therapy is essential to improve surgical outcomes of potentially resectable malignant pleural mesothelioma (MPM), but optimal treatment has not yet been established. To assess compliance and safety of a multimodality therapy consisting of preoperative chemotherapy, surgery and postoperative radiation, a prospective clinical study is planned. Method. We conducted this prospective study as a project of the "Comprehensive approach of asbestos-related diseases" supported by the "Special Coordination Fund for Promoting Science and Technology of the MEXT of Japan". Results. A multi-institutional feasibility study was approved and is now ongoing. Eligible patients will be treated with 3 cycles of chemotherapy using cisplatin and pemetrexed, followed by extrapleural pneumonectomy and postoperative hemithoracic radiation. Primary endpoints are the rate of complete resection and the mortality rate. The expected number of eligible patients participating in the study is 40 during the next 3 years. Conclusion. When this study is completed and the feasibility of multimodality treatment for resectable MPM is confirmed, a phase II study to assess the efficacy may be planned.
journal title
肺癌
volume
Volume 49
issue
Issue 4
start page
403
end page
408
date of issued
2009-08-20
publisher
日本肺癌学会
issn
0386-9628
ncid
publisher doi
language
jpn
nii type
Journal Article
HU type
Journal Articles
DCMI type
text
format
application/pdf
text version
publisher
rights
Copyright (c) 2009 日本肺癌学会
relation is version of URL
http://joi.jlc.jst.go.jp/JST.JSTAGE/haigan/49.403
department
Graduate School of Biomedical Science
Research Institute for Radiation Biology and Medicine