EUCTR2007-002659-17-DE进行中（未招募）1 期
Multicenter, open-label phase II trial on post-surgery chemoradiation in combination with cetuximab in squamous cell carcinoma of the head and neck with high risk of locoregional recurrence. - ACCRA-H
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •-written informed consent
- •- Male or female patients between 18 and 70 years
- •-Surgically resected squamous cell carcinomas of the hypopharynx, oropharynx, larynx and oral cavity with high risk of locoregional recurrence not more than maximum 9 weeks ago
- •-To be categorized as high risk, patients have to fulfil at least one of the following criterias: (R0 - resection <5 mm margin or R1 – resection or Extracapsular nodal extension)
- •-No previous chemotherapy and/or radiotherapy for carcinoma of the head and neck
- •-Performance status ECOG: 0 – 1
- •-Contraception in female partners of male patients and female patients with willingness to use effective contraceptive method for the study duration and 2 months post-dosing
- •-Adequate renal, liver and hematological functions within 9 weeks until surgery:
- •(-Adequate bone marrow function: neutrophils > 1.5 x 10e9/L, platelets > 100 x 10e9/L, hemoglobin > 10.0 g/dL;-Adequate liver function: Bilirubin < 2.0 mg/dL, AST, ALT, AP, ?-GT < 3 x ULN)
- •-Adequate renal function: creatinine clearance > 60 ml/min
- •- No distant metastases.
- •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
- •-Nasopharyngeal carcinoma
- •-R2-resection
- •-Invalid informed consent
- •-Performance Status > 1
- •-Previous chemotherapy or radiotherapy for carcinoma of the head and neck
- •-Prior exposure to EGFR pathway targeting therapy
- •- Other serious illness or medical conditions:(-Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4 or -Clinically significantly abnormal electrocardio-gram (ECG) or left ventricular ejection fraction (LVEF) below the institutional range of the normal or-Significant neurologic or psychiatric disorders including dementia or seizures or-Active uncontrolled infection or -Active disse-minated intravascular coagulation or- Other serious underlying medical conditions which could impair the ability of the patient to participate in the study)
- •-Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC v3.0) grade 2 or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass
- •-Having participated in another therapeutic clinical trial or any investigational agent in the preceding 30 days;
- •-Known allergic/hypersensitivity reaction to any of the components of the treatment
- •-Pregnancy (absence confirmed by serum/urine ß-HCG) or breast-feeding
- •-Known drug abuse of illeagal drugs
- •-Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- •- Legal incapacity or limited legal capacity
- •- Sensitivity and incompatibility against 5-Fluorouracil
- •- Sensitivity and incompatibility against platinum-compounds
- •- Known incompatibilities >grade 3 towards cetuximab
- •- dental evaluation and pre treatment dental care before start of radiochemotherapy
- •- HIV infection
研究者
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