Phase I-/II-study of Hyperfractionated-Accelerated Radiation Therapy plus Cetuximab plus Cisplatin chemotherapy in locally advanced inoperable squamous cell cancers of head and neck

Martin-Luther-University Halle-Wittenberg (Germany)0 个研究点目标入组 92 人开始时间: 2006年8月22日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Patients with histologically confirmed unresectable squamous cell carcinoma (SCC) of the oral cavity (no lip), oropharynx, hypopharynx or larynx (stage III/IVa or b)
•2. Unidimensionally measurable lesion
•3. Signed informed consent
•4. Karnofsky Performance Status more than or equal to 70%
•5. Aged between 18 and 70 years
•6. Curative treatment intent
•7. Negative serum or urine pregnancy test (women of childbearing potential)
•8. Adequate bone marrow, hepatic and renal function
•All patients should have a dental examination and appropriate, dental therapy if required prior to the beginning of radiotherapy. A percutaneous gastrostomy (PEG) is required.

•1. Unknown primary cancer, nasopharynx cancer or salivary gland cancer
•2. Metastatic disease
•3. Another cancer within five years of study entry
•4. Serious concomitant disease or medical condition
•5. Pregnancy or lactation
•6. Women of child-bearing potential with unclear contraception
•7. Previous treatment with chemotherapy, radiotherapy or surgery in head and neck
•8. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
•9. Life expectancy less than three months
•10. Contraindications to receive cisplatin or cetuximab
•11. Previous exposure to monoclonal antibodies and/or epidermal growth factor receptor (EGFR)-targeted therapy
•12. Social situations that limit the compliance with study requirements

发起方

Martin-Luther-University Halle-Wittenberg (Germany)