A multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery vs. neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery vs. neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer - CRITICS-II

The Netherlands Cancer Institute0 个研究点开始时间: 2016年6月29日最近更新: 2017年7月24日

试验速览

暂无简介。

•TNM 7th ed stage IB-IIIC gastric adenocarcinoma (histologically proven); tumour bulk has to be in the stomach but may involve gastro-oesophageal junction
•Performance status WHO < 2
•Age = 18 yrs
•Resectable adenocarcinoma of the stomach or gastro-oesophageal junction
•No prior abdominal radiotherapy
•Haematology: Hb = 5.0 mmol/l; leukocytes = 3.0x109/l, neutrophils = 1.5x109/l, thrombocytes = 100x109/l
•Renal function: serum creatinine = 1.25x ULN, creatinine clearance = 50 ml/min (calculated by Cockcroft and Gault formula)
•Liver function: total bilirubin = 1.5x ULN, alkaline phosphatase and ASAT/ALAT = 3x ULN
•At staging laparoscopy (mandatory) obtained biopsies of suspected peritoneal lesions and/or substantial free peritoneal fluid if any should be pathologically proven tumor negative
•Written informed consent
•Expected adequacy of follow-up
•Caloric intake = 1500 kcal/day, verified by a dietician before registration
•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 190
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 17

•T1N0 disease (assessed by endoscopic ultrasound)
•Distant metastases
•Irresectable/Iinoperable patients; due to technical surgery-related factors or general condition
•Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ cancer of the cervix uteri; in case of a previous other malignancy with a disease-free period = 5 years, inclusion can be accepted after consultation of the principal investigator
•Solitary functioning kidney that will be within the radiation field
•Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery
•Uncontrolled (bacterial) infections
•Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments
•Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias
•Continuous use of immunosuppressive agents equivalent to >10 mg daily prednison
•Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine
•Neurotoxicity > CTC grade 1
•Pregnancy or breast feeding
•Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
•Gastric or gastro-oesophageal stent within radiation field

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