ACTRN12605000701628已完成2 期
A Phase II Feasibility Study Of Pre-Operative And Post-Operative Chemotherapy Using Epirubicin, Cisplatin And Protracted Venous Infusion Fluorouracil (ECF) In Patients With Advanced But Operable Gastric Cancer
AGITG sponsored trial conducted through NHMRC CTC0 个研究点目标入组 60 人开始时间: 2005年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- ot stated 至 ot stated（—）
- 性别
- All
入选标准
- •Histologically verified newly diagnosed locally advanced but operable adenocarcinoma or undifferentiated carcinoma of the stomach (including cardio-esophageal tumours where at least 50% of the tumour involves the stomach).Patient performance status WHO 0-1 (see Appendix 2)Bi-dimensionally measurable or evaluable disease as assessed by upper GI endoscopy, with or without endolumenal ultrasoundPeripheral blood white cell count greater than 3.5x109/l and platelet count greater than 100x109/lA glomerular filtration rate of greater than or equal to 60mls/minute. This can be measured using an EDTA clearance or 24 hour urinary creatinine clearance at the investigators discretionSerum bilirubin of less than or equal to 20mmol/LPatients must not have a history of other malignant diseases other than adequately treated non-melanotic skin cancer or in situ carcinoma of the uterine cervixPatients (male and female) with fertility potential should undertake adequate contraceptionWritten informed consent must be obtained from the patientNo medical or psychiatric condition that impairs the patients ability to give informed consentNo prior chemotherapy or radiation therapyNo uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrhythmias, or any patient with an abnormal ECG or cardiac history having a LVEF of <50% No clinically significant hearing loss.No other serious uncontrolled medical conditions impairing the safety of chemotherapy or surgeryNo pregnant or breast-feeding woman; any woman of childbearing potential must have a pregnancy test prior to treatment No clinical evidence of distant spread, as indicated by hard supraclavicular lymph node enlargment, irregular hepatomegaly, ascites or a rectal shelf indicating transcoelomic spread to the rectovesical or rectovaginal pouch. No evidence of distant spread on Chest X-ray or CT scan of the chest, abdomen, and pelvis.No evidence of Early gastric cancer (Stage Ia) - Endoscopic and histological appearence consistent with a carcinoma which is confined to the mucosa or submucosa.No evidence of esophagogastric or antropyloric obstruction to a degree which prevents ingestion of fluids. (It may be regarded as reasonable to support such a patient with parenteral nutrition through one treatment cycle in the hope that an early response may improve the patient's ability to eat).No prior surgery for the tumour eg bypass, attempted resection or staging (except for laparoscopy)No aspect of the patient which leads the responsible surgeon to believe that the patient represents an especially high operative risk because of build, previous surgery, poor nutritional status or other factors.
排除标准
- •No exclusion criteria
研究者
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