跳至主要内容
临床试验/NCT00436293
NCT00436293已完成2 期

A Randomized Phase II Study of Concurrent Cisplatin-radiotherapy With or Without Neoadjuvant Chemotherapy Using Taxotere and Cisplatin in Advanced Nasopharyngeal Carcinoma (NPC)

Sanofi1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2002年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Sanofi
入组人数
61
试验地点
1
主要终点
Treatment response is evaluated by correlating findings on clinical examination, endoscopy, biopsy, Computed tomography or Magnetic resonance imaging as appropriate.

研究概览

简要总结

Primary objective:

To assess and compare the toxicities of patients with advanced NPC treated with concurrent cisplatin-radiotherapy with or without neoadjuvant Taxotere (docetaxel) and cisplatin.

Secondary objective:

To assess tumor control and survival

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • International Union against Cancer stages III and IV newly diagnosed NPC

排除标准

  • Inadequate bone marrow reserve
  • Inadequate renal function
  • Other primary malignancy
  • Evidence of distant metastases
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

研究组 & 干预措施

2

Active Comparator

Cisplatin and radiotherapy alone without neo-adjuvant chemotherapy

干预措施: Cisplatin (Drug)

1

Experimental

Neo-adjuvant Taxotere followed by cisplatin and radiotherapy

干预措施: Docetaxel (Drug)

结局指标

主要结局

Treatment response is evaluated by correlating findings on clinical examination, endoscopy, biopsy, Computed tomography or Magnetic resonance imaging as appropriate.

时间窗: From administration of drug to end of study

次要结局

  • Adverse Events(From administration of drug to end of study)

研究者

发起方
Sanofi
申办方类型
Industry

研究点 (1)

Loading locations...

相似试验