EUCTR2005-003484-23-DE进行中（未招募）1 期
Randomised phase-III-trial of simultaneous radiochemotherapy (RCT) of locally advanced head and neck cancer in the stages III and IV A-B: Comparing dose reduced RCT (63.6 Gy) with Paclitaxel/Cisplatin to standard RCT (70.2 Gy) with 5-Fluorouracil/Cisplatin - PacCis-RCT
niversitätsklinikum Erlangen, Strahlenklinik insoweit handelnd für den Freistaat Bayern0 个研究点目标入组 542 人开始时间: 2009年12月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 542
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
入选标准
- •1. Histologically proven, locally advanced stage III-IV A-B (UICC 2002) primary squamous cell carcinoma of the oral cavity, the oropharynx, the hypopharynx, the supraglottic larynx
- •2. Age = 18
- •3. Written informed consent for the participation in the clinical trial
- •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 542
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 542
排除标准
- •1. Unadequate hepatic function:
- •Bilirubin > 2,0 mg/dl, SGOT, SGPT, AP, Gamma-GT > 3 x ULN
- •2. Unadequate bone marrow function:
- •Leukocytes < 3,5 x 10^9/l, Platelets < 100 x 10^9/l or Neutrophile < 1,5 x 10^9/l
- •3. Serum creatinine > 1,5 mg/dl, Creatinine-clearance < 60ml/min
- •4. Uncontrolled severe somatic or psychological disease:
- •- unstable angina pectoris, myocardial infarction during the last 6 months, significant cardial rhythm disorders, apoplexy, high grade stenosis of the carotis
- •- neurological or psychiatric disorders including convulsive disorders, dementia, psychosis
- •- active uncontrolled infection or sepsis
- •- liver cirrhosis, Child stage B,C
- •- severe liver function disorders
- •- marginal changes in the blood count
- •- severe kidney damage
- •- HIV-infection
- •5. Acute infections
- •6. Fertile women without adequate contraception during and up to 6 months after therapy (the method of contraception has to be high effective as described in teh Note for guidance on non-clinical safety studies for the conduct of human clinical reials for pharmaceuticals (CPMP/ICH/286/95 mod) and it has to be discussed with the investigator)
- •7. Pregnant or breast feeding women
- •8. Men, who are not willing to use adequate contraception during and up to 6 months after therapy, that is discussed with the investigator
- •9. ECOG-Status > 1
- •10. Reduced hearing function (especially higher frequencies)
- •11. Exsiccose
- •12. Neuropathy, caused by cisplatin
- •13. Concurrent malignancies, with exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma or the cervix
- •14. Prior radiotherapy of the neck or chemotherapy
- •15. Distant metastasis
- •16. Recurrent carcinoma in the head and neck region
- •17. Prior neck-dissection or surgical intervention exceeding an exploratory excision
- •18. Known intolerance to 5-Fluorouracil
- •19. Known deficite of Dihydropyrimidindehydrogenase (DPD)
- •20. Simultaneous therapy with Brivudin or other inhibitors of DPD
- •21. Known intolerance to Cisplatin or other substances that contain platin
- •22. Known intolerance to Paclitaxel or one of the included substances, especially to Poly(oxyethylen)-35-Rhizinusöl/Macrogolglycerolricinoleat
研究者
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