The Clinical Physics Research of Image Guided Adaptive Radiation Therapy for Esophagus Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Toxicity of treatment
研究概览
简要总结
The purpose of this study is to evaluate the benefit of adaptive radiation therapy (adaptive radiation therapy, ART) for esophageal cancer, using dose tracking technique with online images and deformable registration.
详细描述
The aim of study is to evaluate the benefit of adaptive radiation therapy(ART) for esophageal cancer. 80 patients with locally advanced esophageal cancer will be treated with 3D-CRT(three dimensional conformal radiotherapy, 3D-CRT)/IMRT(intensity modulated radiotherapy, IMRT), dividing to experimental group and control group (40 patients each). All patients are kVCT(kilo-voltage computed tomography, kVCT) scanned weekly(the fifth fraction in a week) and CBCT (cone beam computed tomography, CBCT) scanned per fraction before treatment. Irradiated dose distribution of each patient is calculated using the CBCT images corrected with validated modelling and accumulate the volumetric dose for all PTV(planning target volume,PTV) and OARs(organs at risk, OAR) using deformable registration algorithm. For the experimental group, replan the treatment when the target volume is not covered by the prescribed dose or OARs is overdose beyond the action level to achieve an optimal dose distribution. Conversely, no action is taken in the control group and the original plan will be used for the full treatment course. Dosimetric parameters (such as the ratio of target coverage, the mean dose of OARs, etc) ,treatment toxicities (such as radiation pneumonitis and esophagitis), PFS（Progress Free Survival,PFS）and OS（Overall Survival, OS）of the two groups will be analyzed and compared in the study.
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 with locally advanced esophageal cancer
- •ECOG(Eastern Cooperative Oncology Group, ECOG) physical status score：0-2
- •Charlson complications index score≤4
- •First second forced expiratory volume ≥1 liter
- •Patients and their families agreed and signed the informed consent
排除标准
- •Previous treatment with other malignant tumor
- •Had anti-tumor treatment, including (chemotherapy, radiotherapy, surgery)
- •Any taboo disease or condition of radiotherapy and chemotherapy
- •With malignant pleural effusion and pericardial effusion
- •Participated to other clinical test within 30 days before this experiment
- •With uncontrolled seizures or loss of mental self-control
- •Drug takers, chronic alcoholism, and HIV/AIDS patients
- •Has a history of severe allergic or specific physique
- •Researchers think that is unfavorable to the test
研究组 & 干预措施
adaptive radiation therapy (ART)
40 patients treated with ART, using dose adaptation method to match the change of PTV and movement of OARs and achieve an optimal dose distribution using online CBCT images.
干预措施: Dose adaptation (Radiation)
the control group
40 patients treated with original plan for full treatment course.
结局指标
主要结局
Toxicity of treatment
时间窗: One year
Evaluating the treatment toxicity weekly during treatment course and at the time of one year after treatment according to the NCI CTCAE 4.0 (The National Cancer Institute Common Terminology Criteria for Adverse Events,NCI-CTCAE, Version 4.0).
次要结局
- Progress Free Survival(PFS）(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.)
- Overall Survival（OS）(2 years)
研究者
Deng Xiaowu
Director of radiotherapy department
Sun Yat-sen University