A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for T1-T2 Recurrent Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 286
- 试验地点
- 3
- 主要终点
- 3 year Overall Survival (OS) rate
研究概览
简要总结
This study is a multicenter RCT to compare 3-year overall survival(OS) rate, progression free survival(PFS),local progression free survival(LPFS),regional progression free survival(RPFS),distant metastasis free survival(DMFS), and toxicities of endonasal endoscopic surgery versus IMRT.
详细描述
Local and regional recurrence is a common cause of failure after primary radiotherapy for nasopharyngeal carcinoma. Radiotherapy and surgery are the treatments of choice for recurrent NPC. This study aims to compare 3 year overall survival(OS) rate of surgery versus IMRT.A stratified-block randomized approach will be used to randomly assign patients into two treatment groups after stratification according to N staging (N0 vs non-N0). Patients with rNPC will be recruited and randomized into two groups in 1:1 ratio. The primary outcomes will be 3 year overall survival(OS), the secondary outcome measures will be PFS,LPFS,RPFS,DMFS,and toxicities.Assessment will be performed at baseline and during 3 years post-randomization.
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
- •Diagnosed of recurrent nasopharyngeal carcinoma by pathology or imaging study;
- •Stage T1 or T2 according to AJCC 8th edition ;
- •Aged 18 to 70 years;
- •Without metastasis;
- •previously received 1 course of radiotherapy;
- •Without radiotherapy within 1 year, without local treatment for recurrent disease;
- •Surgical resectable and IMRT suitable;
- •If regional recurrence presented, regional lesion can be treated with local treatments.
- •ECOG score 0 or 1;
- •Sufficient organ function;
- •Acceptable approach of contraception.
排除标准
- •Refuse to sign inform consent;
- •Radiation encephalopathy or leptomeningeal disease (LMD);
- •History of radioactive particle planting;
- •Have uncontrolled intercurrent illnesses which will interfere with the ability to undergo therapy;
- •With prior malignancy (excluding adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer );
- •Any contradiction to surgery;
- •Have any co-existing condition that would preclude full compliance or safety with the study;
- •Presence of a significant neurological or psychiatric disease, including dementia and seizures;
- •Uncontrolled infectious diseases;
- •Female patients who are at pregnancy or lactation.
- •Without personal freedom or independent civil capacity.
- •With serious autoimmune disease.
- •Participants of other interventional clinical trial.
结局指标
主要结局
3 year Overall Survival (OS) rate
时间窗: From date of randomization until the date of death from any cause,through study completion,up to 3 years.
The proportion of patients who survived 3 years
次要结局
- Local progression free survival(LPFS)(From randomization to local failure or date of death from any cause,through study completion,up to 3 years.)
- Distant metastasis free survival(DMFS)(From randomization to distant metastasis or date of death from any cause, through study completion,up to 3 years.)
- Regional progression free survival(RPFS)(From randomization to regional failure or date of death from any cause, through study completion,up to 3 years.)
- progression free survival(PFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to 3 years.)
- toxicities(From date of randomization until 3 years after randomization,through study completion,up to 3 years.)
研究者
Hongmeng Yu
MD,PhD
Eye & ENT Hospital of Fudan University