NL-OMON47475已完成不适用
Feasibility of adjuvant treatment with S-1 and oxaliplatin in patients with resectable esophageal cancer - SOX
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Macroscopic radically resected adenocarcinoma of the esophagus
- •- Completed neoadjuvant treatment with paclitaxel 50 mg/m2 and carboplatin AUC
- •<= 2 on and radiotherapy to a total dose of 41.4 Gy in 23 fractions of 1.8 Gy, 5
- •fractions per week, with maximun one missed dose of systemic therapy, not due
- •to haematological toxicity
- •- Being able to start within 16 weeks after esophagectomy
- •- Age * 18 years
- •- WHO performance status 0-1
- •- Adequate bone marrow function (Hb * 6.0 mmol/L, absolute neutrophil count
- •*1.0 x 109/L, platelets * 100 x 109/L), renal function (serum creatinine * 1.5x
- •ULN and creatinine clearance, Cockroft formula, *30 ml/min), liver function
- •(serum bilirubin * 2 x ULN, serum transaminases * 3 x).
- •- Negative pregnancy test in women with childbearing potential.
- •- Expected adequacy of follow-up.
- •- Written informed consent.
排除标准
- •- Any history or clinical signs of metastasis
- •- A second malignancy interfering with the prognosis of current esophageal
- •- Known dihydropyrimidine dehydrogenase (DPD) deficiency or treatment within 4
- •weeks with DPD inhibitors, including sorivudine or its chemically related
- •analogues such as brivudine.
- •- - Significant cardiovascular disease < 1 yr before start of the study (as
- •determined by the investigator, for example: symptomatic congestive heart
- •failure, myocardial ischemia or infarction, unstable angina pectoris, serious
- •uncontrolled cardiac arrhythmia, arterial thrombosis, cerebrovascular event,
- •significant pulmonary embolism).
- •- Chronic active infection.
- •- Any other concurrent severe or uncontrolled disease preventing the safe
- •administration of study drugs.
- •- Any impairment of gastrointestinal function or *disease that may
- •significantly impair the absorption of oral drugs (i.e. uncontrolled nausea,
- •vomiting, diarrhoea (defined as ³CTC grade 2), malabsorption syndrome, bowel
- •obstruction, or inability to swallow tablets).
- •- Concomitant treatments: concomitant (or within 4 weeks before randomisation)
- •administration of any other experimental drug under investigation; concurrent
- •treatment with any other anti-cancer therapy.
- •- Continuous use of systemic immunosuppressive agents (except the use of
- •corticosteroids as anti-emetic prophylaxis/treatment).
研究者
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