演題抄録

International Session

開催概要
開催回
第55回・2017年・横浜
 

EORTC1527/JCOG1609INT: Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) Assessment of Liver Metastasis to Improve Surgical Planning (DREAM)

演題番号 : IS7-4

[筆頭演者]
尾嶋 仁:1 
[共同演者]
岸 庸二:2、女屋 博昭:3、吉田 和弘:4、滝口 伸浩:5、絹笠 祐介:6、滝井 康公:7、池田 聡:8、大植 雅之:9、宮倉 安幸:10、植竹 宏之:11、片岡 幸三:12、須藤 剛:13、塩澤 学:12、Serge Evrard:14

1:群馬県立がんセンター・消化器外科、2:国立研究開発法人国立がん研究センター中央病院・肝胆膵外科、3:栃木県立がんセンター・放射線科、4:岐阜大学・医学部・腫瘍外科、5:千葉県がんセンター・消化器外科、6:静岡県立静岡がんセンター・大腸外科、7:新潟県立がんセンター新潟病院・外科、8:県立広島病院・消化器外科、9:地方独立行政法人大阪府立病院機構大阪府立成人病センター・消化器外科、10:自治医科大学・医学部・外科、11:東京医科歯科大学・大学院・腫瘍化学療法外科、12:地方独立行政法人神奈川県立病院機構神奈川県立がんセンター・消化器外科、13:山形県立中央病院・消化器外科、14:Institut Bergonie, Bordeaux, France

 

For patients with initially unresectable colorectal liver metastases (CRLM) with good clinical response to chemotherapy, the presence of disappearing liver metastases (DLMs) diagnosed by CT is a major independent prognostic factor. DW-MRI as well as contrast enhanced (CE)-MRI is recommended to detect and characterize CRLM. However, the correlation between radiological and pathological complete response has not been fully investigated using these latest imaging and pathology techniques. Based on these backgrounds, EORTC, ESSO and JCOG have initiated first collaboration study. The main aim is to demonstrate the added value of DW-MRI, CE-MRI to that of CT alone to provide precise assessment of DLMs. In addition, we aim to optimize the therapeutic management of CRLM patients.
Patients with unresectable CRLM will receive standard chemotherapy and liver resection if resectable. Confirmed DLMs (cDLMs) are defined as DLM which is not detected by both CT and MRI (DW-MRI, CE-MRI and T1/T2). cDLMs will be either resected or, if remained unresected, followed-up for 2 years after surgery to evaluate the true status of the cDLMs. Quality assurance for imaging, surgery and pathology is performed using guidelines. The primary endpoint is negative predictive value (NPV) of DW-MRI, CE-MRI, T1/T2 and CT in confirming the status of cDLMs using as reference either the histopathological complete response or the absence of a local recurrence at the site of cDLMs during the follow up period of 2 years. The study aims at excluding a NPV≦0.85 and is powered under the alternative that the NPV≧0.95. The planned sample size is 92 evaluable (resected or left behind) cDLMs, with a 1-sided alpha of 5% and a power of 90% adjusting for within-patient correlation between cDLMs of 0.2 and an average number of 2 cDLMs per patient. Approximately 400 patients will be registered from 17 European, 12 Japanese and 2 US sites over 3 years. This study has started since November 2016.

キーワード

臓器別:大腸・小腸

手法別:Clinical Trial (臨床試験)

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