NCT00180973Unknown3 期
MULTICENTRIC INTERNATIONAL RANDOMIZED PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY VERSUS THE SAME NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- 5 year overall survival rate
研究概览
简要总结
MULTICENTRIC INTERNATIONAL RANDOMIZED PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY (BEC REGIMEN) FOLLOWED BY STANDARD RADIOTHERAPY (70 Gy / 7 WEEKS) VERSUS THE SAME NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE (UCNT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •of either sex
- •aged *15 and * 70 years
- •never previously treated with radiotherapy, chemotherapy or surgery for malignant disease (except neck adenectomy/diagnosis)
- •with aWHO performance status *
- •amenable to regular follow-up
- •capable of receiving chemotherapy and radiotherapy : in particular, with no contraindications to the use of anthracyclines, bleomycin or cisplatinum.
- •with informed consent at entry time, in writing or witnessed oral informed consent, in accordance with local legislation requirements.
- •Laboratory requirement : *Baseline hematologic status :
- •Neutrophil count * 2000 /mm3 Platelet count * 150,000 /mm3 Hemoglobin * 10 g / dl
排除标准
- •Histologic types other than type II - III of the WHO classification
- •T1 - T2 N0 - N1 or patients with metastatic
- •Aged < 15 or >
- •Patients in whom chemotherapy is contraindicated: history of myocardial infarction over the last 6 months before inclusion, or clinically present cardiac pathology.
- •WHO Performance status >2
- •History of prior malignancies (other than non melanoma skin cancer or excised cervical carcinoma in situ).
- •Uncontrolled infection,
- •Patients refusing participation.
- •Patients who, for social, familial or geographic reasons are unlikely to comply with a long term follow-up.
结局指标
主要结局
5 year overall survival rate
次要结局
- Time to progresion and local control at 2 years
研究者
研究点 (2)
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