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)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 788
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of combined chemotherapy and radiotherapy (in comparison to chemotherapy alone) as adjuvant treatment after surgery for gastric cancer. Prior to surgery all patients will receive neo-adjuvant chemotherapy as well.
详细描述
The mainstay of curative treatment of gastric cancer is radical surgical dissection. Because most patients in the Western world present with advanced stages long term survival is found in about 25%, with local recurrences as part of treatment failure in up to 80% of cases. Studies examining the role of more extended lymph node dissections (D1 vs. D2), adjuvant radiotherapy or adjuvant chemotherapy did not result in a clinical relevant improvement of survival. In 2001 results of a South West Oncology group (SWOG) trial that randomized between surgery and surgery with chemoradiotherapy were published. This trial, that was hampered by suboptimal surgery (less than D1 in majority of patients) and radiotherapy (2D radiotherapy; 35% protocol deviations) showed an absolute increase in median survival of 9 months. More recently results of the MAGIC study, which randomized between surgery and surgery plus 6 perioperative courses of ECF chemotherapy, were presented. This regimen resulted in an absolute 5-year survival benefit of 13% and in a 10% higher resectability rate.
This phase III prospectively randomized study investigates whether chemoradiotherapy (45 Gy in 5 weeks with daily cisplatin and capecitabine) after preoperative chemotherapy (3x ECC (epirubicin, cisplatin, capecitabine)) and adequate (D1+) surgery leads to improved survival in comparison with postoperative chemotherapy (3x ECC). Furthermore, toxicity of both treatment regimens will be explored.
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
- •Ib-IVa (no distant metastases) gastric cancer (histologically proven); tumor bulk in the stomach
- •Age ≥18 yrs
- •Operable gastric cancer
- •No prior abdominal radiotherapy or chemotherapy
- •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; 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 cardiac disorders
- •Continuous use of immunosuppressive agents
- •Concurrent use of the antiviral agent sorivudine or chemically related analogues
- •Hearing loss > CTC grade 1
- •Neurotoxicity > CTC grade 1
研究组 & 干预措施
1chemoradiotherapy
5 weeksadjuvant treatment; radiotherapy and concomitant chemotherapy with cisplatin and capecitabine.
干预措施: cisplatin+capecitabine (Drug)
1chemoradiotherapy
5 weeksadjuvant treatment; radiotherapy and concomitant chemotherapy with cisplatin and capecitabine.
干预措施: radiotherapy (Radiation)
2chemotherapy
3 adjuvant courses epirubicin, cisplatin, capecitabine.
干预措施: epirubicin+cisplatin+capecitabine (Drug)
结局指标
主要结局
overall survival
时间窗: study duration
次要结局
- disease-free survival(study duration)
- toxicity(study duration)
- health-related quality of life(study duration)