EUCTR2006-004189-14-BE进行中（未招募）不适用
Randomized phase II feasibility study of Cetuximab combined with 4 cycles of TPF followed by platinum based chemo-radiation strategies
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- EORTC
- 入组人数
- 50
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 newly diagnosed unresectable squamous cell carcinoma of the head and neck.
- •¨ Patients who have uni- or bidimensionally measurable disease.
- •¨ Patients must consent to access of their skin and tumor material for EGFR status and downstream signaling.
- •¨ Stage III or IV.
- •¨ Absence of distant metastasis
- •¨ No prior treatment for head and neck cancer
- •¨ No nasopharynx and paranasal cancer
- •¨ Age 18-75
- •- WHO Performance Status 0 or 1
- •¨ WHO Performance Status 0 or 1
- •¨ Normal hematological functions: neutrophils = 1.5 x109 cells/l, platelets = 100 x109 cells/l.
- •¨ Normal liver functions: bilirubin = 1.5 times the upper limit of the normal range; alkaline
- •phosphatase and transaminases = 2.5 times the upper limit of the normal range.
- •¨ Serum creatinine = 120 µmol/l (1.36 mg/dl) and calculated CrCl = 60ml/min.
- •¨ Normal cardiac function(LVEF = 50%), clinically satisfactory 12 lead ECG, and in the past 6
- •months no serious cardiac illness or medical condition
- •¨ All patients (male and female) must use effective contraception methods according to
- •CPMP/ICH/286/95 if of reproductive potential (e.g. implants, injectables, combined oral
- •contraceptives, IUDs, sexual abstinence or vasectomised partner).
- •¨ Females must not be pregnant or lactating.
- •¨ No current malignancies at other sites with the exception of cone biopsied carcinoma of the
- •cervix and adequately treated basal or squamous cell skin carcinoma or other cancer from which
- •the patient has been disease-free for at least last five years.
- •¨ Absence of any unstable systemic diseases or active uncontrolled infections.
- •EORTC 24061 Phase II feasibility study of cetuximab in HNSCC
- •Version 1.0 24 / 95 18 January, 2007
- •¨ Patients may not receive any anticancer therapy, or other investigational agents while on study.
- •¨ Absence of any psychological, familial, sociological or geographical condition potentially
- •hampering compliance with the study protocol and follow-up schedule; those conditions should
- •be assessed with the patient before registration in the trial.
- •¨ Before patient registration/randomization, written informed consent must be given according to
- •ICH/GCP, and national/local regulations.
- •¨ Patients must consent to mandatory translational research project for skin biopsies.
- •There is no reason to believe that the representation of males and females would differ in the studied population, therefore no specific stratification is performed to ensure gender distribution.
- •Patients are informed on the use of their coded data. If the patient refuses to have his/her data used, he/she cannot sign the informed consent and cannot be included in the study.
- •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
- •- pregnant or lactating females
- •- malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma or other cancer from which the patient has been disease-free for at least last five years
- •- Presence of any unstable systemic diseases or active uncontrolled infections.
研究者
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