EUCTR2010-019347-18-DE进行中（未招募）不适用
Randomized Phase II Study of two different Regimens of TPF Induction Chemotherapy Regimen followed by Radiation Therapy plus cetuximab (TPF-CET-HART) vs. HART and Cisplatinum, 5-FU (PF-HART) in Patients with Locally Advanced Unresectable Squamous Cell Carcinomas of the Head and Neck. - ICRAT
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Histologically proven unresectable SCC of the oral cavity, oropharynx and hypopharynx (stage IVa & IVa)
- •Written and signed informed consent
- •Karnofsky PS > 70 %
- •Age = 18 years
- •Curative treatment intent
- •Adequate bone marrow, hepatic and renal functions as evidenced by the following:
- •Hematology (Bone marrow):
- •Neutrophils > 2.0 109/L
- •Platelets > 100 x 109/L
- •Hemoglobin > 10 g/dL
- •Hepatic function
- •Total serum bilirubin < 1 time the upper normal limit (UNL) of the participating center
- •ASAT (SGOT) and ALAT (SGPT) < 2.5 x UNL
- •Alkaline phosphatase < 5 x UNL
- •Renal function :
- •serum creatinine (SC) < 120 µmol/L (1.4 mg/dl);
- •if values are > 120 µmol/L, the creatinine clearance should be > 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows :
- •weight (kg) x (140 - age)
- •---------------------------------
- •K x serum creatinine
- •serum creatinine in mg/dL:K = 72 in man
- •K = 85 in woman
- •serum creatinine in µmol/L:K = 0.814 in man
- •K = 0.96 in woman
- •If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing.
- •All patients require:
- •dental examination and appropriate dental preservation if needed 1 week prior to the beginning of radiotherapy,
- •gastric feeding tube and Portal-catheter.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Other neoplasia within the past 5 years with the exception of a controlled skin cancer or in situ” cervix cancer
- •Unknown primary (CUP), nasopharynx, laryngeal or salivary gland cancer
- •Distant metastatic disease (M1)
- •Serious co-morbidity, e.g. arterosclerosis with apoplexy, recent myocardial infarction, high-grade carotic stenoses, unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4, Insulin-dependent diabetes mellitus, uncontrolled hypertension, liver szirrhosis (Quick < 75%, total protein <3.0 g/dl, bilirubine >2mg/ml) or kidney insufficiency (creatinine >1.4 mg/ml, the creatinine clearance should be > 60 ml/min)
- •patients with ASAT or ALAT > 1.5 UNL associated with alkaline phosphatase > 2.5 UNL are not eligible for the study
- •Known HIV-infection
- •Pregnancy or lactation
- •Women of child-bearing potential with unclear contraception
- •Previous treatment of the disease with chemotherapy, radiotherapy, EGFR-targeting agents or surgery exceeding biopsy in head and neck
- •Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
- •Social situations that limit compliance with study requirements
- •Deficient dental preservation status or not accomplished wound healing
- •Legal incapacity
- •Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 and/or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass
- •Known allergic/hypersensitivity reaction to any of the components of the treatment
研究者
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