2023-503248-15-00进行中（未招募）2 期
CRITICS-II: A multicentre randomized 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
Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis28 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2024年6月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 207
- 试验地点
- 28
- 主要终点
- Event‐free survival at 1 year after randomisation (events: local recurrence, regional recurrence, local‐regional recurrence or progression, distant recurrence, or death from any cause).
研究概览
简要总结
To assess which preoperative regimen provides superior event free survival 1 year after randomisation in patients with resectablegastric cancer
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •TNM 8th ed IB- IIIC gastric cancer (histologically proven); tumour bulk has to be in the stomach but may involvegastro-oesophageal junction
- •Start treatment within 15 working days after randomisation
- •Written informed consent
- •Expected adequacy of follow-up
- •Caloric intake ≥ 1500 kcal/day, verified by a dietician before registration. -- if caloric intake is < 1500 kcal/day or if bodyweight has decreased > 10% over the last 6 months or > 5% over the last month, dietary intervention such as oral nutritional support or enteral tube feeding is mandatory
- •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 freeperitoneal fluid if any should be pathologically proven tumor negative
排除标准
- •T1N0 disease endoscopic ultrasound
- •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-esophageal stent within radiation field
- •Distant metastases
- •Irresectable 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 afterconsultation 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 majorsurgery
- •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
结局指标
主要结局
Event‐free survival at 1 year after randomisation (events: local recurrence, regional recurrence, local‐regional recurrence or progression, distant recurrence, or death from any cause).
Event‐free survival at 1 year after randomisation (events: local recurrence, regional recurrence, local‐regional recurrence or progression, distant recurrence, or death from any cause).
次要结局
未报告次要终点
研究者
Marcel Verheij
Scientific
Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis
研究点 (28)
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