NCT00193284已完成2 期
A Phase I/II Trial of Induction Chemotherapy Plus Gefitinib (Iressa) Followed by Concurrent Chemotherapy, Radiation Therapy, and Gefitinib (Iressa) For Patients With Locally Advanced Squamous Carcinoma of the Head and Neck
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Overall response rate
研究概览
简要总结
Although gefitinib has been combined successfully with various chemotherapeutic regimens with minimal increase in overall toxicity, experience with concurrent radiation therapy is limited. In this trial, we will evaluate the feasibility, toxicity, and effectiveness a novel combination of chemotherapy, radiation therapy, and gefitinib.
详细描述
Upon determination of eligibility, patients will receive:
Induction Therapy
- Docetaxel
- Carboplatin
- 5-FU
- Gefitinib
Combined Modality Therapy
Cohort 1:
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
- 否
入选标准
- •To be included in this study, you must meet the following criteria:
- •Squamous carcinoma of the head and neck.
- •Primary tumor nasopharynx, oral cavity, oropharynx, hypopharynx, and larynx
- •Squamous carcinoma in cervical nodes no identified primary site
- •Must be considered to have low cure rates with local therapy
- •Previously untreated with chemotherapy or radiation therapy.
- •Able to perform activities of daily living without assistance
- •Adequate bone marrow, liver, and kidney function
- •Mild peripheral neuropathy is allowed
- •Measurable or evaluable disease
- •Voluntarily give written informed consent.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Age < 18 years
- •History of prior malignancy within the last five years
- •Severe or uncontrolled systemic disease
- •Significant clinical disorder or laboratory finding
- •Women who are pregnant or breast-feeding
- •Active interstitial lung disease
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
Overall response rate
次要结局
- Overall survival
- Time to progression
- Overall toxicity
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Combination Chemotherapy, Radiation Therapy, and Gefitinib in Treating Patients With Stage III Non-Small Cell Lung CancerAdenocarcinoma of the LungAdenosquamous Cell Lung CancerBronchoalveolar Cell Lung CancerLarge Cell Lung CancerSquamous Cell Lung CancerStage IIIA Non-small Cell Lung CancerStage IIIB Non-small Cell Lung CancerNCT00040794National Cancer Institute (NCI)144
Unknown
2 期
Gefitinib Combined With Chemotherapy or Antiangiogensis in Patients With Bim Deletion or Low EGFR Mutation AbundanceNon-small-cell Lung CancerNCT02930954Caicun Zhou180
已完成
2 期
Induction Chemotherapy With Gemcitabine and Cisplatin Followed by CCRT for Unresectable Pancreatic CarcinomaPancreatic Carcinoma Non-resectableNCT01593475National Cancer Center, Korea44
已完成
2 期
A Randomized Trial of a Combination of Nintedanib/Placebo in Combination With Induction Chemotherapy for Patients With Refractory or First Relapse Acute Myeloid LeukemiaRelapsed/Refractory Acute Myeloid LeukemiaNCT02665143Yale University25
Unknown
2 期
Study of Neoadjuvant Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT01417390First People's Hospital of Foshan80