NCT01693718已完成2 期
A Multicenter Phase II Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Response Rates
研究概览
简要总结
The goal of the study is to test a particular combination of drugs and determine their ability to completely eliminate head and neck cancer.
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
- 59 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria:
- •Patients with Stage IV carcinoma of the nasal or oral cavity, nasopharynx pharynx, larynx, paranasal sinuses, cervical esophagus, or hypopharynx are eligible. Patients with Stage III carcinoma of the nasopharynx, base of tongue and hypopharynx are also eligible. Therapy is given with curative intent.
- •Prior to entry in the study the resectability and standard treatment options for each patient will be determined during a joint evaluation by a team composed of an attending surgeon, a radiation oncologist and a medical oncologist. In addition the timing and feasibility of surgery will be determined in each patient prior to initiation of therapy. The unequivocal demonstration of distant metastasis confers in eligibility.
- •Measurable disease is not required, but all disease will be carefully evaluated.
- •Patients must have a histologically or cytologically confirmed diagnosis of squamous cell carcinoma or lymphoepithelioma.
- •Patients must have not received prior chemotherapy or radiotherapy.
- •Patients must have performance status of >60%
- •Patients must have a WBC count of >3.5, an ANC count >1500 and a platlet count of >100,
- •The serum creatinine must be equal to or less than 1.5 m/dlor the calculated creatinine clearance must exceed 50cc/min.
- •Patient must be free of significant infection or other severe complicating medical illness.
- •Pregnancy will constitute an absolute contraindication to entrance on this protocol. Females of child-bearing age should be using adequate contraception.
排除标准
- 未提供
结局指标
主要结局
Response Rates
时间窗: 2-5 years
To evaluate the activity of 5 cycles of C-FHX/G-CSF in previously untreated patients with stage II and IV locoregionally advanced head and neck cancer.
次要结局
- Feasibility of administering adjuvant CRA and interferon alfa2a(2-5 years)
- Side effects of study regimen(2-5 years)
研究者
研究点 (1)
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