EUCTR2010-021052-25-IT进行中（未招募）不适用
ITACA-S 2 (Intergroup Trial in Adjuvant Chemotherapy for Adenocarcinoma of the Stomach): comparison of the efficacy of a peri-operative versus a post-operative chemotherapy treatment in patients with operable gastric cancer and assessment of the benefit of a post-operative chemo-radiotherapy - ITACA-S 2
IST. DI RICERCHE FARMACOLOG. M. NEGRI0 个研究点开始时间: 2010年8月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •age >18 years ECOG-PS 0-1 T3 or T4 carcinoma without lymphnode involvement (N0) and any T-stage with (N+) lymphnode involvement no distant metastases (M0) fitness to receive CHT and CHT-RTX no peripheral neuropathy greater than grade 1 absence of peritoneal carcinomatosis written informed consents (one for each trial) given before the randomization, according to ICH/GCP
- •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
排除标准
- •adenocarcinoma of the gastro-esophageal junction previous CHT or RTX abnormal haematological, hepatic or renal functions, assessed within 7 days prior to randomization lymphnode metastases (biopsy proof, if possible) outside the loco-regional field, such as supraclavicular, mediastinal or para-aortic nodes positive peritoneal cytology clinical significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), instable angina, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication ITACA-S 2 – Chemotherapy and chemo-radiotherapy in operable gastric cancer Clinical Study Protocol Version 1.0, 25.05.2010 Page 7 of 101 prior or coexisting malignancy within the last 5 years, except curatively treated basal cell skin cancer or carcinoma in situ of the cervix uteri history or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or patients at high risk from treatment complications pregnancy or breast feeding. Women of childbearing potential and their parents must be willing to practice acceptable methods of birth control to prevent pregnancy presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and f-up schedule
研究者
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