PER-045-08已完成未知
International randomized study to evaluate the addition of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) vs. cisplatin-5-fluorouracil (CF) in the induction treatment of nasopharyngeal carcinoma (NPC) in children and adolescents
sanofi-aventis Recherche & Development,0 个研究点目标入组 0 人开始时间: 2008年8月26日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 18（—）
入选标准
- •Histological diagnosis of nasopharyngeal carcinoma WHO type II or III
- •New diagnosis of the disease NPC Stage niB-IV with measurable disease
- •Age eligible for the study: <18 years of age at the time of diagnosis
- •Genders eligible for the study: Both
- •All patients and / or their parents or legal guardians must sign a written informed consent
排除标准
- •Patients with low life expectancy.
- •Chemotherapy or radiotherapy prior to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma
- •Performance status: Patients <16 years of age: Lansky <60%; Patients> 16 years of age: Kamofsky <60%
- •Creatinine excretion or glomerular filtration rate of the radioisotope (GFR) <70 mL / min
- •Bilirubin> 1.5 times the upper limit of normal (ULN) by age
- •AST or ALT> 2.5 times ULN per age
- •Positive pregnancy test
- •Fertile patients without willingness to use effective contraceptives
- •Denial or inability to give informed consent to participate in the study.
研究者
相似试验
进行中（未招募）
1 期
International randomized study to evaluate the addition of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) vs. cisplatin-5-fluorouracil (CF) in the induction treatment of nasopharyngeal carcinoma (NPC) in children and adolescents------------------------------------------Estudio aleatorizado internacional para evaluar la suma de docetaxel a la combinación de cisplatino-5-fluoruracilo (TCF) vs. cisplatino-5-fluorouracilo (CF) en el tratamiento de inducción del carcinoma nasofaríngeo (CNF) en niños y adolescentes. - Docetaxel Pediatric study in NPCEUCTR2007-001211-33-ESsanofi-aventis recherche & développement75
进行中（未招募）
不适用
International randomized study to evaluate the addition of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) vs. cisplatin-5-fluorouracil (CF) in the induction treatment of nasopharyngeal carcinoma (NPC) in children and adolescents - Docetaxel Pediatric study in NPCChildren and adolescents newly diagnosed with NPC with measurable disease T2-T4 any NM, of <18 years of age at the time of diagnosis.MedDRA version: 9.1Level: LLTClassification code 10028793Term: Nasopharyngeal carcinomaEUCTR2007-001211-33-GRsanofi-aventis recherche & développement51
已完成
2 期
A clinical trial to study the effect of Docetaxel when added to standard treatment (Cisplatin and 5-FluroUracil) in Nasopharyngeal Carcinoma in children and adolescents.CTRI/2008/091/000007Sanofi Synthelabo India Limited72
进行中（未招募）
不适用
International randomized study to evaluate the addition of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) vs. cisplatin-5-fluorouracil (CF) in the induction treatment of nasopharyngeal carcinoma (NPC) in children and adolescents - Docetaxel Pediatric study in NPCEUCTR2007-001211-33-DEsanofi-aventis recherche & développement72
进行中（未招募）
1 期
International randomized study to evaluate the addition of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) vs. cisplatin-5-fluorouracil (CF) in the induction treatment of nasopharyngeal carcinoma (NPC) in children and adolescentsEUCTR2007-001211-33-FRsanofi-aventis recherche & développement75