A Phase II Randomized Controlled Study to Compare Endostar and IMRT vs. IMRT Alone for Locally Recurrent Nasopharyngeal Carcinoma Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 96
- 试验地点
- 8
- 主要终点
- Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema
研究概览
简要总结
The purpose of this study is to determine whether endostar and IMRT is effective in the treatment of locally recurrent nasopharyngeal carcinoma patients compared with IMRT alone.
详细描述
Locally recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but severe late toxicities become the most common reason of death in IMRT salvaged NPC patients.
The aim of this phase II randomized controlled study is to address the efficacy of concurrent Endostar (Endostatins) with IMRT to reduce the occurrence of severe late toxicities compared with IMRT alone for locally 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
- •Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma;
- •No evidence of distant metastasis
- •More than 1 year from the end of the first course of radiotherapy
- •Male, or female not in the phase of lactating or pregnancy
- •Aged 18-70 years old
- •WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L
- •Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits
- •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 Endostar
IMRT and concurrent Endostar (Endostatins) to treat locally recurrent NPC patients; Endostar is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles.
IMRT is to give GTV 60Gy in 27 fractions.
干预措施: Endostatins (Drug)
IMRT and concurrent Endostar
IMRT and concurrent Endostar (Endostatins) to treat locally recurrent NPC patients; Endostar is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles.
IMRT is to give GTV 60Gy in 27 fractions.
干预措施: IMRT (Radiation)
IMRT alone
IMRT alone to treat locally recurrent NPC patients. IMRT is to give GTV 60Gy in 27 fractions.
干预措施: IMRT (Radiation)
结局指标
主要结局
Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema
时间窗: From 3 months after the end of IMRT to 1 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)
- Overall survival(From the beginning the IMRT to 3 year after the end of IMRT)
研究者
Fei Han
Associate Professor
Sun Yat-sen University