EUCTR2010-021139-15-DE进行中（未招募）1 期
Do Selective Radiation Dose Escalation and Tumor Hypoxia Status Impact the Locoregional Tumor Control after Radiochemotherapy of Head & Neck Tumors? - ESCALOX
Technische Universität München Fakultät für Medizin0 个研究点目标入组 270 人开始时间: 2010年6月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 270
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
- •Signed written informed consent
- •Age = 18 = 70 years
- •Independent of gender
- •Independent of race
- •ECOG 0 – 2
- •Tumor of oral cavity,oropharynx or hypopharynx
- •Histology: squamous cell carcinoma
- •Curativ etreatment intended
- •Tumor is classified as irresectable (see Appendix)
- •Woman of child-bearing age: negative pregnancy testin serum
- •Contraception in male and female patients and their partners if of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post therapy
- •Sufficient bone marrow reserves during 7 days before study inclusion; (leukocytes = 4 x 109/l, absolute no. of neutrophiles (ANC) = 2 x 109/; thrombocyte count = 100 x 109/l; Hemoglobin = 10g/dl)
- •adequate liver function during 7 days before study inclusion (total bilirubine = 2,5 x ULN (upper limit of normal), ASAT/ ALAT = 2,5 x ULN, alkaline phosphatase = 2,5 x ULN of the institution’s normal value)
- •adequate kidney function during 7 days before study inclusion; serum creatinine = 130 µmol/l; creatinine clearance = 70 ml/min
- •all patients should have a dental examination before starting therapy and when necessary be treated, adaptation of a teeth protection bar
- •a percutane feeding tube should be applied before start of treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Patients are not eligible for this study if they fulfill one or more of the following exclusion criteria:
- •Infiltration of the mandible and / or larynx
- •impaired renal and/ or liver function
- •secondary malignancy, unknown primary cancer, nasopharynx cancer or salivary gland cancers
- •Metastatic disease
- •Another cancer within 5 years of study entry
- •Serious concomitant disease or medical condition
- •Pregnancy or lactation
- •Women of child-bearing potential with unclear contraception (post menopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential)
- •previous treatment with chemotherapy, radiotherapy or surgery in head and neck (except an excisional biopsy or biopsy for histology)
- •concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
- •life expectancy of < 1 year
- •contraindications to receive Cisplatin
- •social situations that limit compliance with study requirements
研究者
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