演題抄録

口演

開催概要
開催回
第58回・2020年・京都
 

COVID-19感染症拡大下におけるJCOG-EORTC 国際共同研究の現状

演題番号 : O8-4

[筆頭演者]
片岡 幸三:1,2 
[共同演者]
高橋 侑子:4、寺田 参省:2、盛 啓太:5、池田 正孝:1、塩澤 学:6、金光 幸秀:3、Serge Evrard:7、中村 健一:2、福田 治彦:2、Denis Lacombe:4

1:兵庫医科大学・下部消化管外科、2:国立がん研究センター中央病院・臨床研究支援部門、3:国立がん研究センター中央病院・大腸外科、4:European Organisation for Treatment and Research of Cancer、5:静岡県立静岡がんセンター、6:神奈川県立がんセンター、7:Université de Bordeaux

 

All cancer researches including clinical trial are largely being affected by COVID-19. Especially, international clinical trial which may need larger number of discussions, is much more challenging. EORTC-JCOG collaborative study, EORTC-1527-GITCG-IG/JCOG1609INT (DREAM), which aims to investigate the diagnostic performance of MRIs and CT scan for identifying the viability of disappearing colorectal liver metastases after chemotherapy has started since 2016 and 222 patients (140 from Japan) have been registered as of May 2020. However, only 4 patients have been registered in Japan and no patients in EU since Feb 2020. The JCOG datacenter and EORTC headquarter have to shift remote working, minimizing their administrative functions.
Although the two centers have decided not to stop the patients recruitment, they have to focus their effort on the safety of the patients; First, EORTC recommends to obtain patients re-consent especially when the local investigators think it risky to keep involving the patients in the trial. Second, both groups allow protocol deviation, such as fewer patients visit with some delays and administration of part of protocol treatment at neighbor hospitals. Patient phone visits instead of physical visits is recommended when no physical examination is planned in EU, especially in France. Second, the two centers have recommended to report SAE as described in the protocol, to secure the patient safety. Especially EORTC has decided when there is a suspected or confirmed serious case of COVID-19 infection, which is considered by the investigator to be causally related to the study required procedures, report it as SAE.
Taking into account the situation in each country which may vary among each other, flexible management through online-meeting is important to minimize the risk of the patients and keep the benefit of the trial.

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臓器別:その他

手法別:臨床試験

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