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
- 试验地点
- 5
- 主要终点
- Primary end point:
研究概览
简要总结
Trial will be conducted in 16 countries all over the world The Indian target - 6 patients. Indian status - 5 patients randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Month(s) 至 21.00 Year(s)（—）
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 carcinoma3.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 age6.AST or ALT >2.5 times ULN for age7.Hypersensitivity to one of the drugs or their excipients.8.Pregnant or breast feeding females9.Females of child bearing potential who are unwilling or unable to be tested for pregnancy10.Females of child bearing potential who are unwilling or unable to use effective contraception11.Refusal or inability to give informed consents to participate in the study.
结局指标
主要结局
Primary end point:
时间窗: 2 years
Complete response (CR) rate following the Induction treatment and prior to the radiation treatment.
时间窗: 2 years
次要结局
- Secondary end points:(1.Overall safety and efficacy of docetaxel in combination with CF.)
研究者
研究点 (5)
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