EUCTR2014-000048-14-DE进行中（未招募）1 期
Randomized, controlled trial of Platinum-Cetuximab combined either with Docetaxel (TPEx) or with 5FU (Extreme) in patients with recurrent/metastatic squamous cell cancer of the head and neck
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GORTEC
- 入组人数
- 540
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 confirmed diagnosis squamous cell carcinoma of head and neck: oral cavity, oropharynx, hypopharynx, larynx (histological confirmation is mandatory at least for initial diagnosis)
- •Recurrence and/or metastatic disease not suitable for local therapy
- •At least one measurable lesion (RECIST) by CT or MRI
- •Age = 18 years and < 71 years
- •Clearance of creatinine > 60ml/mn (MDRD)
- •Haematological function as follows: absolute neutrophil count > 1.5 x 109/l, platelet > 100 x 109/l, hemoglobin = 9.5 g/dl
- •Hepatic function as followed: bilirubin = Upper limit of normal (ULN); SGOT/SGPT < 1.5 ULN; AP < 2.5 ULN
- •Estimated life expectancy > 12 weeks
- •Informed Consent Form signed
- •Affiliation to an health insurance
- •Negative pregnancy test in women of childbearing potential within 14 days prior to treatment initiation (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization). Both men and women (of childbearing potential) who are sexually active must use adequate contraception, during and for at least 6 months post-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 540
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with nasopharyngeal cancer, paranasal sinus cancer or unknown primary
- •Prior systemic chemotherapy for the head and neck carcinoma, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry
- •Surgery (excluding diagnostic biopsy) or radiotherapy within 6 weeks before study entry
- •Contra-indication to receive cisplatin
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Administration of prophylactic phenytoin
- •Recent or planed yellow fever vaccination
- •Prior dose of cisplatin > 300 mg/m² (a patient who received prior RT + 3 cycles of cisplatin or 3 cycles induction TPF, i.e. total dose of cisplatin = 300 mg/m², for locally advanced primary HN cancer can be included)
- •Prior anti-EGFR treatment received less than 12 months before enrolment in the trial
- •Known hypersensitivity reaction to 5FU, cisplatin, carboplatin, docetaxel or cetuximab
- •Documented or symptomatic brain or leptomeningeal metastasis
- •Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months
- •Other malignancies within 5 years prior to randomization, with the exception of adequately treated basal skin cancer and carcinoma in situ of the cervix.
- •Active infection (infection requiring IV antibiotics), including active tuberculosis and known and declared human immunodeficiency virus (HIV).
- •Significant disease which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial.
- •Any social, personal, medical and/or psychologic factor(s) that could interfere with the observance of the patient to the protocol and/or the follow-up and/or the signature of the informed consent.
- •Pregnant or breast feeding women
研究者
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