Change in Metabolic Tumour Activity Seen at Sequential FDG-PET and Plasma/Tissue miRNA as a Biomarkers of Preoperative Treatment Strategy in Locally Advanced Oesophago-Gastric Cancer

Masarykuv onkologický ústav0 个研究点目标入组 70 人开始时间: 2019年11月19日最近更新: 2023年8月21日

适应症

试验速览

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•1.Age of 18 years or more
•2.Not currently participating in another study
•3.Able and willing to sign informed consent and to comply with study procedures
•4.Biopsy-proven locally advanced resectable oesophago-gastric adenocarcinoma (Siewert I – III) with T3N0, T4N0, T2 – T4N+, stage Ib – IIIc I.Adenocarcinoma of distal part of the oesophagus II.Adenocarcinoma of the real cardia III.Adenocarcinoma of the subcardial stomach
•5.Staging procedures include endoscopy, endoscopic ultrasound and FDG-PET
•6.Eligible patients have to be fit for platinum-containing chemotherapy
•7.Tumours must be potentially R0 resectable tumours during consecutive operation.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1.Participation in another clinical trial of a therapeutic drug during the past 14 days
•2.Addiction to alcohol or drugs
•3.Women of child-bearing potential who are not using a commonly accepted effective means of contraception; women of child-bearing potential will have negative blood pregnancy test before enrollment
•4.Pregnant women and nursing mothers are not allowed to enroll on this study
•5.Eastern Cooperative Oncology Group score >2
•6.Previous or secondary malignancy in past 5 years (Excluding skin cancer and early cervical carcinoma)
•7.Life expectancy of less than 3 months
•8.Uncontrolled bleeding from the tumour
•9.Uncontrolled diabetes
•10.Patients are also ineligible if they have undergone previous chemotherapy, radiotherapy, or endoscopic laser therapy for EGJ

发起方

Masarykuv onkologický ústav