NL-OMON50400招募中3 期
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
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 500 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •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
- •Total bilirubin <=1.5x ULN, Alkaline phosphatase and ASAT/ALAT <= 3x ULN
- •Left ventricular ejection fraction > 50%
- •Tumornegative laparoscopy when CT suggests peritoneal carcinomatosis
- •Start treatment within 10 working days after registration
- •Written informed consent
排除标准
- •T1N0 disease (endoscopic ultrasound)
- •Distant metastases
- •Inoperable patients
- •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
- •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
研究者
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