A multicenter randomized phase III trial of neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy in resectable gastric cancer (CRITICS-study: ChemoRadiotherapy after Induction chemoTherapy In Cancer of the Stomach) - CRITICS

KI/Antoni van Leeuwenhoek Ziekenhuis0 个研究点开始时间: 2010年12月17日最近更新: 2012年3月19日

研究概览

暂无简介。

•Ib-IVa (no distant metastases) gastric cancer (histologically proven); tumor bulk has to be in the stomach but may involve gastro-esophageal junction
•age =18 yrs
•Operable gastric cancer
•No prior abdominal radiotherapy or chemotherapy
•Hematology: Hb > 5.0 mmol/l; leukocytes > 3.0x109/l, neutrophils > 1.5x109/l, thrombocytes > 100 x 109/l
•Renal function: serum creatinine = 1.25 ULN, creatinine clearance > 60 ml/min (measured, or calculated by Cockcroft and Gault formula) and urinary excretion of = 1.0 gram protein/24 hours
•Liver function: total bilirubin =1.5x ULN, Alkaline phosphatase and ASAT/ALAT = 3x ULN
•Left ventricular ejection fraction > 50%
•Tumornegative laparoscopy when CT suggests peritoneal carcinomatosis
•Written informed consent
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•T1N0 disease (endoscopic ultrasound)
•Distant metastases
•Inoperable 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.
•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 arrhytmias
•Continuous use of immunosuppressive agents
•Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine
•Hearing loss > CTC grade 1
•Neurotoxicity > CTC grade 1
•Pregnancy or breast feeding
•Patients (M/F) with reproductive potential not implementing adequate contraceptive measures

发起方

KI/Antoni van Leeuwenhoek Ziekenhuis