EUCTR2014-000048-14-ES进行中（未招募）不适用
Randomized, controlled trial of Platinum-Cetuximab combined either withDocetaxel (TPEx) or with 5FU (Extreme) in patients withrecurrent/metastatic squamous cell cancer of the head and neck
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GORTEC
- 入组人数
- 416
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 < 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; PAL < 2.5 ULN
- •? Life expectancy > 12 weeks.
- •? 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 416
- •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.
- •? 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
- •? Prior anti-EGFR treatment received less than 12 months before
- •enrolment in the trial
- •? Known hypersensitivity reaction to any study medication
- •? 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
- •? Active infection (infection requiring IV antibiotics), including active
- •tuberculosis and known and declared human immunodeficiency virus
- •? 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 inform consent.
- •? Pregnant or breast feeding women
研究者
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