跳至主要内容
临床试验/NCT00875849
NCT00875849已完成2 期

Phase II Study Evaluating Radiotherapy-chemotherapy and Cetuximab in Patients With Histologically Proven Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx and With a Poor Prognosis After Complete Surgical Resection

Centre Antoine Lacassagne1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2008年3月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
53
试验地点
1
主要终点
Disease-free survival at 2 years

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with radiation therapy and cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well chemotherapy given together with radiation therapy and cetuximab works in treating patients with head and neck cancer.

详细描述

OBJECTIVES:

Primary

  • Evaluate disease-free survival at 2 years in patients with poor prognosis squamous cell carcinoma of the head and neck treated with chemoradiotherapy and cetuximab after complete surgical resection.

Secondary

  • Evaluate quality of life.
  • Evaluate tolerability.
  • Evaluate overall survival.
  • Analyze germinal polymorphisms.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Cetuximab

Experimental

干预措施: cetuximab (Biological)

Cetuximab

Experimental

干预措施: cisplatin (Drug)

Cetuximab

Experimental

干预措施: radiation therapy (Radiation)

结局指标

主要结局

Disease-free survival at 2 years

时间窗: 2 YEARS

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验