ACTRN12609000730202已完成2 期
Induction chemotherapy with cisplatin, epirubicin and paclitaxel (CEP), followed by concomitant radiotherapy and weekly cisplatin versus the same concomitant chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.A randomized phase II study conducted by the Hellenic Cooperative Oncology Group
Hellenic Cooperative Oncology Group0 个研究点目标入组 148 人开始时间: 2009年8月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 15 Years 至 o limit（—）
- 性别
- All
入选标准
- •Disease characteristics:
- •1.Biopsy - proven, previously untreated, World Health Organisation (WHO) type I, II or undifferentiated NPC.
- •2.Stage IIB-IVB [Union Internationale Contre le Cancer (UICC) and the American Joint Committee on Cancer (AJCC)] after pre-therapeutic extensive workup 3.Measurable or evaluable disease required.
- •3. No synchronous primary tumors.
- •4. Chest x-ray, bone scan and liver imaging prior to initiation of treatment.
- •5. Computed tomography (CT) scan and/or Magnetic Resonance Imaging (MRI) of the head and neck region prior to initiation of treatment.
- •Patient characteristics:
- •1. Age: 15 years and over.
- •2. Performance status: WHO 0 - 2
- •3. Hematopoietic: White Blood Cells (WBC) > 3,500 and platelets >100,000.
- •4. Renal: creatinine clearance >50 ml/min (measured or calculated) and serum calcium normal.
- •5. Hepatic: Alkaline phosphatase (ALP) and Serum glutamic oxaloacetic transaminase (SGOT) normal.
- •6.Cardiovascular: status adequate to tolerate all protocol treatment.
- •7.Pulmonary: status adequate to tolerate all protocol treatment.
- •8.Nutritional status: status adequate to tolerate all protocol treatment.
- •9.Mental status: adequate to follow instructions, keep appointments and provide written informed consent prior to study entry.
- •10.Life expectancy of at least 3 months.
排除标准
- •Prior therapy:
- •No prior biologic, chemotherapy, surgery or radiotherapy to the head and neck is allowed.
研究者
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