EUCTR2011-005820-17-IT进行中（未招募）1 期
eoadjuvant afatinib based treatment strategies followed by surgery in squamous cell carcinoma of the head and neck: an EORTC NOCI-HNCG window study. - Neoadjuvant afatinib window study in SCCH
E.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER0 个研究点目标入组 30 人开始时间: 2012年9月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Newly diagnosed histologically proven squamous cell carcinoma of the oral cavity; oropharynx; hypopharynx or larynx.
- •Patients selected for a primary surgical treatment.
- •Performance status ECOG 0-1
- •Within 2 weeks prior to randomiwation:
- •Adequate bone marrow function
- •Adequate hepatic function times ULN
- •Adequate renal function as demonstrated by serum creatinine
- •Controlled blood pressure
- •Adequate cardiac function
- •FDG PET/CT
- •DCE MRI and DWI MRI performed
- •Primary tumor =2 cm in their largest diameter measured bidimensionally by imaging done within 2 weeks prior to randomization
- •Availability of tumor and normal mucosa biopsies during staging endoscopy (please refer to surgical guidelines for further information)
- •Availability of blood samples for Translational research
- •Age =18 years
- •Negative pregnancy test
- •Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Patients with nasopharynx, nasal cavity and paranasal sinuses carcinomas, or recurrent/metastatic SCCHN
- •T3-T4 hypopharyngeal SCCHN
- •No distant metastasis
- •Active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix
- •Prior chemotherapy, radiotherapy or targeted therapy including HER inhibitors (monoclonal antibodies or tyrosine kinase inhibitors) for SCCHN
- •No concomitant use of Potent P-gp inhibitors, Potent P-gp inducers, Erythropoietin (EPO)
- •No evidence of diabetes
- •No evidence of interstitial lung disease
- •No weight loss of more than 10% in the previous 6 months
- •Serious underlying medical conditions which could impair the ability of the patient to participate in the study
- •Participation in another interventional clinical trial in the preceding 30 days prior to randomization
研究者
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