EUCTR2011-003950-24-GB进行中（未招募）1 期
PHASE II TRIAL OF PALLIATIVE EPIRUBICIN, OXALIPLATIN & CAPECITABINE (EOX) CHEMOTHERAPY COMBINED WITH OMEGA-3 FISH OIL INFUSION (OMEGAVEN) IN PATIENTS WITH OESOPHAGO-GASTRIC CARCINOMA - PALLIATIVE EOX & OMEGAVEN IN OESOPHAGO-GASTRIC CANCER PATIENTS
niversity Hospitals of Leicester NHS Trust0 个研究点目标入组 21 人开始时间: 2012年1月5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
- 21
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
- •Histologically confirmed gastric or oesophageal carcinoma (irrespective of subtype), deemed incurable as a result of standard staging investigations. • Measurable disease according to RECIST v1.1 criteria on CT within 4 weeks of study entry • WHO Performance status 0-2 • Aged >18 years • Able to give informed written consent • Life expectancy >12 weeks • Adequate hepatic and renal function documented within 7 days prior to treatment (estimated GFR>50ml/min, serum bilirubin <1.5x ULN; ALT or AST <2.5x ULN; ALP <3x ULN (in the absence of liver metastases). If liver metastases are present, serum transaminases <5x ULN are permitted.) • Adequate bone marrow function documented within 7 days (Haemoglobin =9g/dL, Platelets =100,000 cells/mm3, Neutrophil Count =1500 cells/mm3) • Women of childbearing age must have a negative pregnancy test (urine or serum) at commencement of treatment • Willing to use contraception if applicable • Willingness to comply with scheduled visits, treatment, laboratory test, and other aspects of the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Prior radical treatment within 6 months of relapse • Prior treatment with any systemic chemotherapy for metastatic disease • Prior adjuvant radio- or chemotherapy within 4 weeks of starting the study • Patients with locally advanced disease deemed suitable for radical chemo-radiotherapy • Known hyperlipidaemic state (use of a statin permissible) • Patients with known coagulation disorders • Hypersensitivity to fish, egg protein or to any of the active substances or constituents in the lipid emulsion • Any general contra-indications to infusion therapy – pulmonary oedema, hyperhydration, decompensated cardiac insufficiency • Any unstable medical conditions – uncontrolled diabetes mellitus, acute myocardial infarction, stroke, embolic disease, metabolic acidosis, sepsis, pancreatitis • Known HIV or hepatitis B or C carrier • Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with requirements of the protocol • History of malignancy other than gastric or oesophageal cancer, with the exception of curative treatment for skin cancer (other than melanoma) or in situ breast or cervical carcinoma, or those treated with curative intent for any other cancer with no evidence of disease for 5 years • Major surgical procedure or significant traumatic injury within 4 weeks of treatment • Cerebral metastases • History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan • Known peripheral neuropathy > Grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible). • Lack of physical integrity of the upper gastro-intestinal tract, malabsorption syndrome, or inability to take oral medication (administration of capecitabine by naso-gastric or jejunostomy feeding tube is permitted).
研究者
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