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
- 发起方
- Sanofi
- 入组人数
- 75
- 试验地点
- 26
- 主要终点
- Number of Participants With Complete Response (CR)
研究概览
简要总结
The primary objective is to estimate the Complete Response rate of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in the Induction treatment of Nasopharyngeal Carcinoma (NPC).
The secondary objectives are to determine:
- the safety of TCF in comparison to CF after induction treatment of NPC,
- the pharmacokinetics of docetaxel when added to CF,
- the Overall Response rate of TCF and CF on completion of induction and consolidation (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and CF.
详细描述
Planned treatment duration:
- induction period: 9 weeks of induction treatment
- consolidation period: 9 weeks of chemoradiation treatment.
The consolidation treatment was the same for all participants: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.
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
- 1 Month 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of nasopharyngeal carcinoma World Health Organization (WHO) type II or III
- •Children and adolescents newly diagnosed with Stage IIB-IV NPC with measurable disease, who are >1 month to ≤21 years of age at the time of diagnosis. In France, participants must be ≥1 year to ≤21 years of age at the time of diagnosis
排除标准
- •Participants with short life expectancy
- •Prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma
- •Inadequate renal function evidenced by unacceptable laboratory results
- •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Docetaxel/Cisplatin/5-FU (TCF)
- Docetaxel 75 milligrams per square meter (mg/m²) over 1 hour on Day 1 every 3 weeks
- Cisplatin 75 mg/m² Day 1 over 6 hours every 3 weeks
- 5-Fluorouracil 750 mg/m²/day continuous infusion Days 1 to 4 every 3 weeks as an induction therapy
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.
干预措施: docetaxel (Drug)
Docetaxel/Cisplatin/5-FU (TCF)
- Docetaxel 75 milligrams per square meter (mg/m²) over 1 hour on Day 1 every 3 weeks
- Cisplatin 75 mg/m² Day 1 over 6 hours every 3 weeks
- 5-Fluorouracil 750 mg/m²/day continuous infusion Days 1 to 4 every 3 weeks as an induction therapy
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.
干预措施: cisplatin (Drug)
Docetaxel/Cisplatin/5-FU (TCF)
- Docetaxel 75 milligrams per square meter (mg/m²) over 1 hour on Day 1 every 3 weeks
- Cisplatin 75 mg/m² Day 1 over 6 hours every 3 weeks
- 5-Fluorouracil 750 mg/m²/day continuous infusion Days 1 to 4 every 3 weeks as an induction therapy
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.
干预措施: 5-fluorouracil (Drug)
Cisplatin/5-FU (CF)
- Cisplatin 80 mg/m² Day 1 over 6 hours every 3 weeks
- 5-Fluorouracil 1000 mg/m²/day continuous infusion Day 1 to 4 every 3 weeks as an induction therapy.
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.
干预措施: cisplatin (Drug)
Cisplatin/5-FU (CF)
- Cisplatin 80 mg/m² Day 1 over 6 hours every 3 weeks
- 5-Fluorouracil 1000 mg/m²/day continuous infusion Day 1 to 4 every 3 weeks as an induction therapy.
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.
干预措施: 5-fluorouracil (Drug)
结局指标
主要结局
Number of Participants With Complete Response (CR)
时间窗: after the completion of the induction treatment (up to 9 weeks)
CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the induction treatment and prior to the radiation treatment. CR defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
次要结局
- Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group(Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion)
- Overall Response (OR)(after the completion of the consolidation treatment (up to 18 weeks))
- Overall Survival (OS) Rate(3 years after the end of the consolidation treatment period (up to 40 months from randomization))