EUCTR2008-006802-40-DK进行中（未招募）1 期
A PHASE II STUDY WITH OXALIPLATIN + 5FU + CETUXIMAB AND RADIOTHERAPY FOR TREATMENT OF NON-RESECTABLE, LOCALLY ADVANCED BUT NOT METASTATIC CANCER OF OESOPHAGUS OR THE CARDIA REGION - LERFOX-C
Akademiska University Hospital0 个研究点目标入组 90 人开始时间: 2011年1月13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
- 90
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 squamous cell carcinoma (including
- •basaloid-squamous cell and adenosquamous carcinoma) or
- •adenocarcinoma of the esophagus or the esophagogastric
- •junction (types I and II according to the Siewert
- •classification)
- •Performance status (WHO) 0-2, age 18-80 y
- •Locally advanced disease non-resectable (T4 N0-N3, M0) or disease which is not operable for any other reason (T2/T3 N0-N3, M0)
- •Adequate hematological values: neutrophils = 1.5 x 109/L,
- •platelets = 100 x 109/L, Hb =9.0g/dL
- •- Adequate liver function:bilirubin = 1.5 x ULN, AP = 2.5 x
- •ULN, AST & ALT = 1.5 x ULN
- •- Adequate renal function: GFR > 60 mL/min or Serum
- •creatinine: = 100 mikromol/l
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •Distant metastases
- •Prior chemotherapy or radiotherapy for oesophageal ca or ca of the cardia region
- •Symptomatic peripheral neuropathy equal to or greater than NCI grade 2
- •Other concomitant serious illness or medical condition that would not permit the patient to complete the study treatment or sign the informed concent
- •? Severe or uncontrolled cardiovascular disease (congestive
- •heart failure NYHA III or IV), unstable angina pectoris,
- •history of myocardial infarction within the last 12 months,
- •significant arrhythmias)
- •? Active uncontrolled infection
- •? Serious underlying medical condition (judged by the
- •investigator) which could impair the ability of the patient to
- •participate in the trial (e.g. uncontrolled diabetes mellitus,
- •active autoimmune disease)
- •? Concurrent treatment with other experimental drugs or other
- •anti-cancer therapy; treatment in a clinical trial within 30
- •days prior to trial entry
- •? Definite contraindications for the use of corticosteroids and
- •antihistamines as premedication
- •? Known hypersensitivity to trial drugs or hypersensitivity to
- •any other component of the trial drugs
- •? Any concomitant drugs contraindicated for use with the trial
- •drugs according to the product information of the
- •pharmaceutical companies
- •Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) unless treated, in remission and off active treatment for greater than 5 years
- •- Breastfeeding women
研究者
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