EUCTR2006-004189-14-IT进行中（未招募）1 期
Randomized phase II feasibility study of cetuximab combined with 4 cycles of TPF followed by platinum based chemo-radiation strategies - ND
E.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER0 个研究点目标入组 0 人开始时间: 2009年3月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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, nasal and paranasal cancer Age 18-75 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 (< 1.36mg/dl) and calculated CrCl ≥ 60ml/min Patients having 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. 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 can only be registered / randomized in this trial once.
- •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 women -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 year. -Presence of any unstable systemic diseases or active uncontrolled infections
研究者
相似试验
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 strategiesHistologically proven newly diagnosed unresectable squamous cellcarcinoma of the head and neckEUCTR2006-004189-14-HUEORTC50
已完成
2 期
Randomized phase II feasibility study of Cetuximab combined with 4 cycles of TPF followed by platinum based chemo-radiation strategieshead and neck carcinomalaryngeal cancer10027655NL-OMON32191EORTC10
进行中（未招募）
1 期
Randomized phase II feasibility study of Cetuximab combined with 4 cycles of TPF followed by platinum based chemo-radiation strategiesEUCTR2006-004189-14-NLEORTC
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 strategiesHistologically proven newly diagnosed unresectable squamous cellcarcinoma of the head and neckEUCTR2006-004189-14-BEEORTC50
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 strategiesEUCTR2006-004189-14-DEEORTC50