EUCTR2007-005976-15-GB进行中（未招募）1 期
A randomised open-labelled multicentre trial of the efficacy of epirubicin, oxaliplatin and capecitabine (EOX) with or without panitumumab in previously untreated advanced oesophago-gastric cancer (REAL3) - REAL3
Royal Marsden Hospital NHS Trust0 个研究点目标入组 553 人开始时间: 2008年2月29日最近更新:
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
- 553
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 verified inoperable locally advanced or metastatic adenocarcinoma or undifferentiated carcinoma of the oesophagus, oesophago-gastric junction, or stomach.
- •Slides of tumour tissue should be available
- •Uni-dimensionally measurable disease (CT or MRI as per RECIST).
- •No prior chemotherapy for advanced oesophago-gastric cancer (patients who have received prior adjuvant chemotherapy may be included if relapse has occurred 6 months or greater after completion of chemotherapy).
- •No prior radiotherapy other than previous adjuvant treatment, where relapse has occurred outside the radiotherapy fields.
- •Male/female patients aged =18 years.
- •WHO Performance status 0, 1 or 2.
- •Life expectancy of at least 3 months.
- •Completion of baseline quality of life questionnaire (EORTC QLQ C30).
- •Adequate left ventricular ejection fraction > 50% (determined by MUGA scan or ECHO).
- •Adequate bone marrow, renal and liver function
- •Written informed consent
- •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
- •Tumours of squamous histology.
- •Patients with locally advanced oesophageal cancer suitable for definitive chemoradiotherapy.
- •Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease.
- •Previous chemotherapy, unless peri-operative or adjuvant therapy completed > 6 months prior to disease relapse.
- •Any radiotherapy or major surgery within 4 weeks prior to the start of study treatment.
- •Any prior treatment with an EGFR signal transduction directed therapy.
- •Clinically significant (i.e. active) cardiac disease
- •History of interstitial lung disease
- •Known peripheral neuropathy = Grade 1
- •Lack of physical integrity of the upper gastro-intestinal tract, malabsorption syndrome, or inability to take oral medication
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •known hypersensitivity to panitumumab, components of the EOX regimen, or any of the constituents of these agents.
- •Known positive tests for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection.
- •Other clinically significant disease or co-morbidity which may adversely affect the safe delivery of treatment within this trial.
- •Female patients who may be pregnant or breastfeeding. Potential female patients of childbearing potential must have a negative pregnancy test within 7 days prior to randomization, or have had amenorrhea for more than 2 years.
- •Patients of child-bearing potential not consenting to use adequate contraceptive precautions or abstinence during the course of the study and for 6 months after the last study drug administration for females, and 1 month for males.
- •Any other malignancies within the last 5 years
研究者
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