EUCTR2007-001211-33-ES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 NPC
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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
- •Histological diagnosis of nasopharyngeal carcinoma WHO type II or III
- •Newly diagnosed disease NPC Stage IIB-IV disease with measurable disease
- •Ages eligible for study: <=18 years of age at time of diagnosis.
- •Genders eligible for study: Both
- •All patients and/or their parents or legal guardians must sign a written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with short life expectancy.
- •Prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma
- •Performance status (Appendix C)
- •- Patients = 16 years of age: Lansky <60%
- •- Patients > 16 years of age: Karnofsky <60%
- •Creatinine clearance or radioisotope glomerular filtration rate (GFR) <70 mL/min OR
- •- Serum creatinine based on age as follows for the calculation of GFR:
- •Greater than 0.8 mg/dL (for patients = 5 years of age)
- •Greater than 1.0 mg/dL (for patients 6-10 years of age)
- •Greater than 1.2 mg/dL (for patients 11-15 years of age)
- •Greater than 1.5 mg/dL (for patients > 15 years of age)
- •Bilirubin > 1.5 times upper limit of normal (ULN) for age
- •AST or ALT > 2.5 times ULN for age
- •Positive pregnancy test
- •Fertile patients unwilling to use effective contraception
- •Clinical Trial Protocol 24 February 2007
- •Property of the sanofi-aventis group - strictly confidential Page 29
- •WW-CLIN-PR007-SD-03 VERSION n°03 (22-FEB-2006)
- •Refusal or inability to give informed consents to participate in the study
研究者
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