NCT00625937Unknown2 期
A Phase ll Trial of Induction Docetaxel and S-1 Followed by Concomitant Radiotherapy With Low-dose Daily Cisplatin in Locally Advanced Head and Neck Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Objective response rate (complete or partial response) as assessed by RECIST criteria
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, S-1, and 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. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and S-1 together with radiation therapy and low-dose cisplatin works in treating patients with stage III or stage IV head and neck cancer.
详细描述
OBJECTIVES:
Primary
- To assess the response rate in patients with stage III or IV head and neck cancer treated with induction therapy comprising docetaxel and S-1 followed by radiotherapy and low-dose cisplatin.
Secondary
- To assess the effect of this regimen on survival and locoregional and systemic control rates in these patients.
研究设计
- 研究类型
- Interventional
- 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
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Pathologically confirmed head and neck cancer arising from the oral cavity, oropharynx, hypopharynx, or nasopharynx, including any of the following subtypes:
- •Squamous cell carcinoma
- •Poorly differentiated carcinoma
- •Lymphoepithelioma
- •Locally advanced disease (stage III or IV [M0] disease)
- •At least 1 unidimensionally measurable index lesion
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •ANC ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9 g/dL
- •Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 3.0 times ULN
- •AST and ALT ≤ 3.0 times ULN
- •Creatinine ≤ 1.5 times ULN
- •No concurrent serious systemic disorder that, in the opinion of investigator, would compromise the patient's ability to complete the study
- •No serious cardiac condition, including any of the following:
- •Myocardial infarction within the past 6 months
- •NYHA class III-IV heart disease
- •No active infection requiring IV antibiotics, including active tuberculosis or HIV
- •No other malignancy within the past 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- •Able to comply with protocol or study procedures
- •PRIOR CONCURRENT THERAPY:
- •No prior radiotherapy or chemotherapy
排除标准
- 未提供
结局指标
主要结局
Objective response rate (complete or partial response) as assessed by RECIST criteria
次要结局
- Toxicity as assessed by NCI CTCAE v3.0 criteria
- Progression-free survival
- Overall survival
研究者
研究点 (1)
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