A Phase II Study of Accelerated Hypofractionated Three-dimensional Conformal Radiation Therapy Concurrent With Chemotherapy in Unresectable Stage III Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- Number of Participants with Severe and Life-threatening Adverse Events (AE)
研究概览
简要总结
The purpose of this study is to evaluate the safety of accelerated hypofractionated three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent with chemotherapy for patients with unresectable stage III non-small cell lung cancer.
详细描述
Increasing the biological effective dose (BED) of radiotherapy for non-small cell lung cancer (NSCLC) can increase local control rates and improve overall survival. Compared with conventional fractionated radiotherapy, accelerated hypofractionated radiotherapy can yield higher BED, shorten the total treatment time, and theoretically obtain better efficacy. However, currently, there is no optimal hypofractionated radiotherapy regimen. Based on phase I trial results, we performed this phase II trial to further evaluate the safety and preliminary efficacy of accelerated hypofractionated three-dimensional conformal radiation therapy(3-DCRT) combined with concurrent chemotherapy for patients with unresectable stage III NSCLC.
Patients with previously untreated unresectable stage III NSCLC received 3-DCRT with a total dose of 69 Gy, delivered at 3 Gy per fraction, once daily, five fractions per week, completed within 4.6 weeks. At the same time, platinum doublet chemotherapy was applied.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological or cytological diagnose of unresectable stage III non-small cell lung cancer
- •The Karnofsky performance status (KPS) score ≥
- •The expected survival time ≥3 months.
- •Adequate blood, liver, lungs and kidney function
- •Accessible contact information
- •Informed consent required before enrollment.
排除标准
- •Pregnant or breastfeeding.
- •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)
- •Cannot receive concurrent chemotherapy due to medical reasons.
- •Superior vena cava syndrome.
- •Severe lung diseases that affected lung function.
结局指标
主要结局
Number of Participants with Severe and Life-threatening Adverse Events (AE)
时间窗: Baseline to the time of intolerable toxicity(up to 1 year) or measured Progressive Disease (PD)
intolerable toxicities: severe and life-threatening adverse events (Grade III/IV in Common Terminology Criteria for Adverse Events v3.0 (CTCAE 3.0))
次要结局
- Percentage of Participants with Progression Free Survival (PFS) at 1 Year(Baseline and 1 year)
研究者
LIN QIANG
Professor
North China Petroleum Bureau General Hospital