Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 109
- 主要终点
- Two Year Event-free Survival (EFS)
研究概览
简要总结
This phase III trial is studying how well radiation therapy, amifostine, and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with amifostine and chemotherapy may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. Determine the response rate, overall survival, and event-free survival of children with advanced nasopharyngeal carcinoma who are treated with induction chemotherapy followed by concurrent chemoradiotherapy and amifostine.
SECONDARY OBJECTIVES:
I. Characterize the role of Epstein-Barr virus (EBV) in the pathogenesis of nasopharyngeal carcinoma in children.
II. Investigate the predictive value of the detection of EBV DNA in the peripheral blood of children with nasopharyngeal carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of nasopharyngeal carcinoma WHO type II or III
- •Stage I-IV disease
- •Newly diagnosed disease
- •Performance status
- •Patients ≤ 16 years of age: Lansky 60-100%
- •Patients > 16 years of age: Karnofsky 60-100%
- •Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
- •Creatinine based on age/gender as follows:
- •No greater than 0.4 mg/dL (for patients 1 month to < 6 months of age)
- •No greater than 0.5 mg/dL (for patients 6 months to < 1 year of age)
- •No greater than 0.6 mg/dL (for patients 1-2 years of age)
- •No greater than 0.8 mg/dL (for patients < 6 years of age)
- •No greater than 1.0mg/dL (for patients 6 to < 10 years of age)
- •No greater than 1.2 mg/dL (for patients 10 to < 13 years of age)
- •No greater than 1.4 mg/dL (for female patients 13 to ≥ 16 years of age)
- •No greater than 1.5 mg/dL (for male patients 13 to < 16 years of age)
- •No greater than 1.7 mg/dL (for male patients ≥ 16 years of age)
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
- •AST or ALT < 2.5 times ULN for age
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma
排除标准
- 未提供
研究组 & 干预措施
Stratum I (radiotherapy, chemoprotective agent)
Patients undergo radiotherapy 5 days a week for 8 weeks. Patients also receive amifostine subcutaneously on the same days they undergo radiotherapy.
干预措施: Amifostine (Drug)
Stratum I (radiotherapy, chemoprotective agent)
Patients undergo radiotherapy 5 days a week for 8 weeks. Patients also receive amifostine subcutaneously on the same days they undergo radiotherapy.
干预措施: Laboratory Biomarker Analysis (Other)
Stratum I (radiotherapy, chemoprotective agent)
Patients undergo radiotherapy 5 days a week for 8 weeks. Patients also receive amifostine subcutaneously on the same days they undergo radiotherapy.
干预措施: Radiation Therapy (Radiation)
Stratum II (chemotherapy, chemoprotective agent, radiotherapy)
Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiotherapy and receive amifostine as in stratum I. Patients also receive 3 courses of cisplatin as before.
干预措施: Amifostine (Drug)
Stratum II (chemotherapy, chemoprotective agent, radiotherapy)
Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiotherapy and receive amifostine as in stratum I. Patients also receive 3 courses of cisplatin as before.
干预措施: Cisplatin (Drug)
Stratum II (chemotherapy, chemoprotective agent, radiotherapy)
Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiotherapy and receive amifostine as in stratum I. Patients also receive 3 courses of cisplatin as before.
干预措施: Fluorouracil (Drug)
Stratum II (chemotherapy, chemoprotective agent, radiotherapy)
Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiotherapy and receive amifostine as in stratum I. Patients also receive 3 courses of cisplatin as before.
干预措施: Laboratory Biomarker Analysis (Other)
Stratum II (chemotherapy, chemoprotective agent, radiotherapy)
Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiotherapy and receive amifostine as in stratum I. Patients also receive 3 courses of cisplatin as before.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Two Year Event-free Survival (EFS)
时间窗: Up to Two Year After Enrollment
The two-year event-free survival will be compared with a standard established from adult oncology data and the results of POG-9486. The two-year Kaplan-Meier estimate of event-free survival will be compared with 70% using a 1-sided test of size 0.05 using the asymptotic distribution of the complementary log-log distribution of the estimate.
次要结局
- Predictive Value of Epstein-Barr Virus (EBV) DNA as Measured by Quantitative Detection at Enrollment on EFS 2 Years After Treatment(At study enrollment)
- Predictive Value of the Detection of EBV DNA in the Peripheral Blood(Up to 6 years)
- Prognostic Significance of EBV Viral Load(At study enrollment)
- Protective Effects of Amifostine Assessed Primarily by Sialometry(At study enrollment)
- Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams.(At study enrollment)