Moderate Hypofractionated(3Gy/f) Radiotherapy for Advanced Lung Cancer: a Retrospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Incidence of grade III and above radiation-reduced esophagitis
研究概览
简要总结
The purpose of this study is to evaluate the incidences of Grade III and above radiation-reduced esophagitis and radiation-reduced pneumonia of patients with advanced lung cancer treated with moderate hypofractionated (3Gy/f) radiotherapy, and their predictors. Efficacies are also evaluated.
详细描述
Radiotherapy plays an irreplaceable role in lung cancer. However, due to the long duration of conventional fractionation irradiation, tumor cells will accelerate repopulation after 3 to 4 weeks during radiotherapy, resulting in decreased efficacy. Hypofractionated radiation is increasingly used in radiotherapy of lung cancer. It can shorten the overall treatment time, and can potentially reduce the effect of tumor accelerated repopulation. Compared with conventional radiotherapy, hypofractionated radiotherapy can theoretically obtain a higher biological effective dose (BED). The application of Stereotactic Body Radiation Therapy (SBRT) or Stereotactic Ablative Radiotherapy (SABR) in advanced or central lung cancer is restricted when the tumors are adjacent to important organs. Moderate hypofractionated radiotherapy can not only shorten the overall total treatment time, but also reduce the severe toxicities. It is widely used in lung cancer nowadays. However, most data of the tolerated doses for normal tissue and organs comes from conventional radiotherapy. Whether or not it is suitable for hypofractionated radiotherapy has not been determined. In our study, the incidences of Grade III and above radiation-reduced esophagitis and radiation-reduced pneumonia, as well as their predictors, were obtained by retrospective analysis of patients received moderate hypofractionated radiotherapy of 3Gy/f. At the same time, the efficacies of this scheme are also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with previously untreated advanced lung cancer were recruited, who were confirmed pathologically or cytologically.
- •The Karnofsky performance status (KPS) score ≥
- •The expected survival time was≥3 months.
- •The laboratory examination results showed a neutrophil count ≥2.0 × 109, a hemoglobin level ≥100 g/L, a platelet count ≥100 × 109, and enough liver and kidney functions.
- •The patients did not show abnormal electrocardiogram (ECG) results.
- •They did not have other combined diseases that required hospitalization.
- •Informed consent required before enrollment.
排除标准
- •Patients who were pregnant or breastfeeding.
- •Patients who had another malignant tumor history (with the exception of patients with cervical carcinoma in situ and non-malignant melanoma skin cancer that had been clinically cured for at least 5 years), could not receive concurrent chemotherapy due to medical reasons.
- •Superior vena cava syndrome.
- •Syndrome and severe lung diseases that affected lung function were excluded.
结局指标
主要结局
Incidence of grade III and above radiation-reduced esophagitis
时间窗: three years
Incidence of grade III and above radiation-reduced esophagitis
Incidence of grade III and above radiation-reduced pneumonitis
时间窗: three years
Incidence of grade III and above radiation-reduced pneumonitis
次要结局
- Objective Response Rate(three years)
- Local Control Rate(three years)
- Progression Free Survival(three years)
- Median Survival Time(three years)
- Overall Survival(three years)