Phase II Study of Concomitant Fluorouracil, Hydroxyurea, Cetuximab and Hyperfractionated Intensity Modulated Radiation Therapy for Locally Advanced Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Llocoregional Recurrence
研究概览
简要总结
For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more aggressive approach may be needed for these patients to prevent recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of patients are cured with this strategy. While cure rates are higher than standard chemotherapy and radiation and the treatment is tolerable, side effects during treatment are common. We propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab. Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 否
入选标准
- •Age 18 years or older
- •Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas of the head and neck or lymphoepithelioma
- •No prior chemotherapy or radiotherapy
- •Prior surgical therapy will consist only of incisional or excisional biopsy, and organ sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an existing primary tumor
- •Karnofsky performance status of >= 70%
- •Intact organ and bone marrow function
- •Obtained informed consent
排除标准
- •Demonstration of metastatic disease (i.e. M1 disease).
- •Patients with a history of severe allergic reaction to docetaxel or other drugs formulated with polysorbate
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, 5-fluorouracil, or hydroxyurea.
- •Other coexisting malignancies or malignancies diagnosed within the previous 3 years with the exception of basal cell carcinoma, cervical cancer in situ, and other treated malignancies with no evidence of disease for at least 3 years.
- •Prior surgical therapy other than incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor. Any non-biopsy procedure must have taken place less than 3 months from initiating protocol treatment.
- •Incomplete healing from previous surgery
- •Pregnancy or breast feeding (men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary artery disease will be at the discretion of the attending physician.
- •Uncontrolled active infection unless curable with treatment of their cancer.
研究组 & 干预措施
Advanced Head and Neck Cancer
Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck
干预措施: Cetuximab (Drug)
Advanced Head and Neck Cancer
Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck
干预措施: Hydroxyurea (Drug)
Advanced Head and Neck Cancer
Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck
干预措施: Fluorouracil (Drug)
Advanced Head and Neck Cancer
Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck
干预措施: radiotherapy (Procedure)
结局指标
主要结局
Llocoregional Recurrence
时间窗: 2 years
Percentage of Participants with Loco-regional recurrence.
Survival
时间窗: 2 years
Overall Survival - Percentage of Participants who survived Disease-Free Survival - measured from the initiation of nonsurgical treatment to either the last follow-up, disease progression, or death using intent-to-treat methodology
次要结局
- Long- Term Toxicity(2 years)
- UW-QOLR: Quality of Life Score(2 years)
- Distant Metastases(2 years)
研究者
Johnny Kao
Assistant Professor
Icahn School of Medicine at Mount Sinai