CTRI/2008/091/000007已完成2 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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
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
入选标准
- •1.Histological confirmed nasopharyngeal carcinoma, subtypes WHO type II (non-keratinizing carcinoma) or III (undifferentiated carcinoma including lymphoepitheliomas)
- •2.Newly diagnosed disease NPC Stage IIB-IV disease with measurable disease.
- •3.Ages eligible for study: >1 month to ≤21 years of age at time of diagnosis.
- •4.Genders eligible for study: Both
- •5.All patients and/or their parents or legal guardians must sign a written informed consent and assent.
排除标准
- •1.Patients with short (less than 12 weeks) of life expectancy.
- •2.Prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma
- •3.Performance status:
- •− Patients ≤16 years of age: Lansky <60%
- •− Patients >16 years of age: Karnofsky <60%
- •4.Creatinine clearance or radioisotope glomerular filtration rate (GFR) <70 mL/min OR Serum creatinine based on age as follows for the calculation of GFR to :
- •− 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)
- •5.Bilirubin >1.5 times upper limit of normal (ULN) for age
- •6.AST or ALT >2.5 times ULN for age
- •7.Hypersensitivity to one of the drugs or their excipients.
- •8.Pregnant or breast feeding females
- •9.Females of child bearing potential who are unwilling or unable to be tested for pregnancy
- •10.Females of child bearing potential who are unwilling or unable to use effective contraception
- •11.Refusal or inability to give informed consents 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
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
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 Stage IIB-IV with measurable disease, of >1 month to =21 years of age at the time of diagnosis.MedDRA version: 14.1Level: LLTClassification code 10028793Term: Nasopharyngeal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2007-001211-33-Outside-EU/EEAsanofi-aventis recherche & développement72