Intensity-modulated Radiotherapy Plus Concurrent Chemotherapy Versus Intensity-modulated Radiotherapy Alone In Patients With rT3/T4 Locally Advanced Recurrent Nasopharyngeal Carcinoma: A Phase 3 Multicenter Prospective Randomised Controlled Trial (IMRT)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone.
详细描述
Locally T3/T4 recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but local control is not good enough and late toxicities is usually severe The aim of this phase III randomized controlled study is to address the efficacy of concurrent chemotherapy (cisplatin) with IMRT to improve local control and lower the occurrence of severe late toxicities compared with IMRT alone for locally T3/T4 recurrent NPC patients.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma;
- •2.No evidence of distant metastasis
- •3.More than 1 year from the end of the first course of radiotherapy
- •4.Male, or female not in the phase of lactating or pregnancy
- •6.Aged 18-70 years old
- •7.WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L
- •8.Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits
- •9.Written informed consort signed
排除标准
- •Only regionally recurrence
- •Evidence of distant metastasis
- •Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
- •Severe, active co-morbidity
- •Prior anti-tumor treatment after diagnosis of local recurrence
- •MRI was not performed 3 months after the first course of radiotherapy
- •Abnormal function of heart, brain and lungs, etc
- •Lactation or pregnancy
- •Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence
研究组 & 干预措施
IMRT and concurrent cisplatin
IMRT and concurrent cisplatin to treat T3/T4 locally recurrent NPC patients. Cisplatin 100mg/M2 is to give D1,D22 of IMRT for 2 cycles. IMRT is to give GTV 60Gy in 27 fraction
干预措施: Cisplatin (Drug)
IMRT and concurrent cisplatin
IMRT and concurrent cisplatin to treat T3/T4 locally recurrent NPC patients. Cisplatin 100mg/M2 is to give D1,D22 of IMRT for 2 cycles. IMRT is to give GTV 60Gy in 27 fraction
干预措施: IMRT (Radiation)
IMRT alone
IMRT alone to treat T3/T4 locally recurrent NPC patients. IMRT is to give 60Gy in 27 fraction
干预措施: IMRT (Radiation)
结局指标
主要结局
Overall survival
时间窗: From the beginning the IMRT to 3 year after the end of IMRT
次要结局
- Number of participants with severe acute toxicities as assessed by CTCAE v3.0(From the beginning of IMRT to 3 months after the end of IMRT)
- Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema(From 3 months after the end of IMRT to 1 year after the end of IMRT)
研究者
Fei Han
professor
Sun Yat-sen University