A Phase II Clinical Trial Evaluating the Role of FLT PET/CT in Predicting Treatment Response of Carbon-ion Radiotherapy for Patients With Locoregionally Recurrent Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Sensitivity and specificity
研究概览
简要总结
We aim, in this study, to examine whether reduction of FLT PET derived SUV before and after carbon ion radiotherapy can predict the treatment response and survivals for patients with locoregionally recurrent nasopharyngeal carcinoma.
详细描述
This is a single-arm phase II clinical trial evaluating the prognostic value of FLT PET/CT for patients with locoregionally recurrent nasopharyngeal carcinoma. All patients will receive FLT PET/CT scans before and after carbon ion radiotherapy (CIRT). The sensitivity and specificity of reduction of FLT uptake reduction in terms of predicting the treatment outcome evaluated by MRI at 3 months after completion of CIRT according to RECIST 1.1. Its predictive value of OS, LPFS, RPFS and DMFS will be examined as well.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed as primary nasopharyngeal carcinoma;
- •With recurrence at nasopharynx and/or recurrent retropharyngeal lymph node, recurrence was diagnosed by imaging or pathology studies;
- •Already received one course of definitive radiation therapy, at least 6 months ago;
- •Able to receive contrast MRI scan and PET/CT scan;
- •ECOG: 0-2;
- •Anticipated survival time >= 12 months;
- •With sufficient major organ functions;
- •Willing to sign informed consent.
排除标准
- •Metal implants that might significantly influence the radiation dose distribution;
- •Dose constrains for organs-at-risk are beyond acceptable limit;
- •With comorbidities/conditions that might influence the effectiveness of carbon-ion therapy;
- •Pregnant or within lactation period;
- •Drug/alcohol addiction;
- •With mental disorder that might impede the completion of therapy.
结局指标
主要结局
Sensitivity and specificity
时间窗: The reduction of FLT uptake will be calculated over two time points, at the baseline and at the time point that CIRT is completed.
The sensitivity and specificity of FLT uptake reduction in predicting the treatment response evaluated by MRI scan at 3 months after completion of CIRT.
次要结局
- Overall survival (OS)(Duration from the date the diagnosis of LR-NPC is made until date of patient death or the last follow-up, whichever comes first, assessed up to 36 months)
- Local progression-free survival (LPFS)(Duration from the date the diagnosis of LR-NPC is made until date of documented local failure or the last follow-up/patient death, whichever comes first, assessed up to 36 months)
- Regional progression-free survival (RPFS)(Duration from the date the diagnosis of LR-NPC is made until date of documented regional failure or the last follow-up/patient death, whichever comes first, assessed up to 36 months)
- Distant metastasis-free survival (DMFS)(Duration from the date the diagnosis of LR-NPC is made until date of documented distant metastasis or the last follow-up/patient death, whichever comes first, assessed up to 36 months)
研究者
Jiade J. Lu
Professor
Shanghai Proton and Heavy Ion Center