EUCTR2014-002362-74-SE进行中（未招募）不适用
Palliative short-course hypofractionated radiotherapy followed by chemotherapy in adenocarcinoma of the esophagus or esophogastric junction trial - a phase II clinical trial protocol. - PALAESTRA
Skåne University Hospital, Department of Oncology0 个研究点开始时间: 2014年6月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •- Patients with histologically proven adenocarcinoma of the esophagus or esophago-gastric junction (Siewert
- •I-III) not eligable for surgery or chemoradiation with curative intent
- •- TNM: any T, N and M
- •- Age: 18 years or older
- •- WHO performance status = 2
- •- Life expectancy > 3 months
- •- Dysphagia score > 0 (see section 9.1)
- •- Adequate laboratory findings:
- •hematological: hemoglobin > 90 g/L (may be transfused to maintain or exceed this level), absolute neutrophil count (ANC) = 1,0 x 109/L, platelets =
- •hepatic: bilirubin = 1.5 x ULN, ALAT = 5 x ULN
- •renal: creatinine = 1.5 x ULN
- •- Fertile men and women must use effective means of contraception
- •- Signed written informed consent
- •- The patient must be able to comply with the protocol
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •- Prior treatment with self-expanding metal stent (SEMS), radiotherapy or chemotherapy for the present disease
- •- Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA)
- •grade III-IV congestive heart failure
- •- Severe pulmonary disease e.g. pulmonary fibrosis.
- •- Symptomatic peripheral neuropathy greater than grade 1 (CTCAE version 4.0)
- •- Known hypersensitivity to any contents of the study drugs
- •- Pregnancy (positive pregnancy test) and/or breast feeding
- •- Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial
研究者
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