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
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
- 26
- 主要终点
- Event-Free survival
研究概览
简要总结
The CRITICS-II trial aims to identify the optimal preoperative regimen in resectable gastric cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and subsequent chemoradiotherapy vs. chemoradiotherapy. The rationale behind this trial design is based on the following concepts:
- Preoperative treatment is associated with better patient compliance than postoperative regimens
- Preoperative treatment increases the likelihood of disease downsizing/downstaging and radical R0 resections
- Preoperative paclitaxel/carboplatin-based concurrent chemoradiotherapy and DOC chemotherapy are effective, feasible and safe regimens
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TNM 8th ed stage IB-IIIC gastric cancer (histologically proven); tumour bulk has to be in the stomach but may involve gastro-oesophageal junction
- •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.
- •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
排除标准
- •T1N0 disease (assessed by 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; 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-esophageal stent within radiation field
研究组 & 干预措施
neo-adjuvant chemotherapy followed by surgery
4 courses of 3 weekly DOC followed by surgery
干预措施: Docetaxel (Drug)
neo-adjuvant chemotherapy followed by surgery
4 courses of 3 weekly DOC followed by surgery
干预措施: Oxaliplatin (Drug)
neo-adjuvant chemotherapy followed by surgery
4 courses of 3 weekly DOC followed by surgery
干预措施: Capecitabine (Drug)
neo-adjuvant chemotherapy followed by surgery
4 courses of 3 weekly DOC followed by surgery
干预措施: gastrectomy (Procedure)
neo-adjuvant chemo and subsequent CRT followed by surgery
2 courses of 3 weekly DOC and subsequent CRT followed by surgery
干预措施: Docetaxel (Drug)
neo-adjuvant chemo and subsequent CRT followed by surgery
2 courses of 3 weekly DOC and subsequent CRT followed by surgery
干预措施: Oxaliplatin (Drug)
neo-adjuvant chemo and subsequent CRT followed by surgery
2 courses of 3 weekly DOC and subsequent CRT followed by surgery
干预措施: Capecitabine (Drug)
neo-adjuvant chemo and subsequent CRT followed by surgery
2 courses of 3 weekly DOC and subsequent CRT followed by surgery
干预措施: gastrectomy (Procedure)
neo-adjuvant chemo and subsequent CRT followed by surgery
2 courses of 3 weekly DOC and subsequent CRT followed by surgery
干预措施: radiotherapy of gastric cancer (Radiation)
neo-adjuvant chemo and subsequent CRT followed by surgery
2 courses of 3 weekly DOC and subsequent CRT followed by surgery
干预措施: Paclitaxel (Drug)
neo-adjuvant chemo and subsequent CRT followed by surgery
2 courses of 3 weekly DOC and subsequent CRT followed by surgery
干预措施: Carboplatin (Drug)
neo-adjuvant chemoradiotherapy followed by surgery
chemoradiotherapy followed by surgery
干预措施: gastrectomy (Procedure)
neo-adjuvant chemoradiotherapy followed by surgery
chemoradiotherapy followed by surgery
干预措施: radiotherapy of gastric cancer (Radiation)
neo-adjuvant chemoradiotherapy followed by surgery
chemoradiotherapy followed by surgery
干预措施: Paclitaxel (Drug)
neo-adjuvant chemoradiotherapy followed by surgery
chemoradiotherapy followed by surgery
干预措施: Carboplatin (Drug)
结局指标
主要结局
Event-Free survival
时间窗: 1 year
Event-free survival will be measured by clinical outcome and CT-scan
次要结局
- Time to Event (events: local recurrence, regional recurrence, local-regional recurrence or progression, distant recurrence, or death from any cause)(1 year)
- Time to recurrence (events: local recurrence, regional recurrence, local-regional recurrence or progression, distant recurrence)(1 year)
- Toxicity(1 year)