EUCTR2017-004500-22-IT进行中（未招募）1 期
Phase II multicentre trial of perioperative chemotherapy in operable patients with gastric cancer (PERISCOPE trial) - Ph II CT of perioperative chemotherapy in operable patients with gastric cancer
GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)0 个研究点目标入组 65 人开始时间: 2018年3月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 65
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
- •1.Males or females = 18 years old;
- •2.Written, signed consent for trial participation;
- •3.Patients should consent to optional provision of a sample of blood (30 ml) and urine (10 ml) at basal time and every month during neoadjuvant, before surgery, one month after surgery, at the end of adjuvant treatment and every 4 months during follow-up (in order that specific correlative marker assays could be performed);
- •4.Patients should also consent to optional provision of available histological tissue (e.g. bioptic and surgical tissue) in order that correlative marker assays could be performed;
- •5.Histological or cytological diagnosis of GC;
- •6.Clinical staging of GC cT2-4/cN-any/cM0 or cT-any/cN+/cM0 (according to the 8th edition of the UICC TNM classification performed with thoraco-abdominal CT scan, ecoendoscopy and esophagogastroduodenoscopy performed within 4 weeks prior to randomization;
- •7.No prior treatments (chemo or radiotherapy);
- •8.Measurable disease, defined in accordance with RECIST (Response Evaluation Criteria in Solid Tumors) criteria version 1.1, evaluated with ecoendoscopy, esophagogastroduodenoscopy and thoraco-abdominal CT scan;
- •9.Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- •10.Adequate organ function assessed within 4 weeks prior to randomization including:
- •a.Hematologic: absolute neutrophil count (ANC) = 1.5 x 109/L, platelets = 100 x 109/L, haemoglobin = 9.0 g/dL;
- •b.Hepatic: bilirubin = 1.5 times upper limits of normal (ULN), alanine transaminase (ALT) = 3 times ULN;
- •c.Renal: Serum creatinine =1.5 times ULN.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.ECOG PS > 1;
- •2.Metastatic Gastric Cancer;
- •3.Previous chemo or radiotherapy;
- •4.Current active infection;
- •5.Serious pre-existing medical conditions or serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator (for example, unstable angina pectoris, or a clinically significant history of cardiac disease or renal disease, neurological disease or condition of peripheral neuropathy);
- •6.Females who are pregnant or lactating;
- •7.Patients with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 3 years;
- •8.Patients unable to undergo medical test for geographical, social or psychological reason;
- •9.Known dihydropyrimidine dehydrogenase (DPD) deficiency.
研究者
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