Hypofraction Radiotherapy for Limited-Stage Small Cell Lung Cancer: A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rate of radiation-induced pneumonitis (CTCAE V4.0)
研究概览
简要总结
Concurrent chemoradiotherapy is the standard modality for locally advanced small-cell lung cancer, which could achieve median overall survival of 25 mos. Conventional fractionation of 66Gy/33f and hyperfractionation of 45Gy/30f twice daily have been acknowledged as the two standard radiotherapy modalities according to CONVERT study. In 2021, a phase II trial demonstrated that 60Gy/40f twice daily was superior to the standard 45Gy/30f twice daily in light of overall survival (2y OS 74.2% vs. 39% p=0.0005), which to some extent implied that higher dose may confer better survival. Hypofractionated radiotherapy was another useful modality to increase biological effective dose with the advantage of short course and convenience. The effectiveness and safety of 60Gy/15f has been demonstrated in the treatment of locally advanced non-small cell lung cancer. Therefore, this trial is designed to explore the safety and primary efficacy of hypofraction radiotherapy for stage III locally advanced small cell lung cancer.
详细描述
Trial Design: To enroll 36 patients diagnosed with limited stage small cell lung cancer to receive hypofraction radiotherapy (18 patients receiving high dose of 60Gy/15f and 18 patients receiving low dose of 48Gy/12f).
Primary Endpoint: Rate of radiation-induced penumonitis, esophagitis, myelosuppression (CTCAE V4.0).
Secondary Endpoint: 1-year local-regional control rate, 1-year progression-free survival rate, 1-year overall survival rate (RECIST v1.1).
Randomization: Patients would be randomly assigned to high dose group and low dose group using random number table method.
Radiotherapy CT simulation: 4-Dimensional CT (4D-CT) with intravenous contrast is recommended for simulation. Scan thickness should be less than 5 mm. Thermal mask or vacuum bag is recommended.
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
- •18-75 years old;
- •ECOG 0-1;
- •Small cell lung cancer;
- •Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonagraph, bone scan or cranial MRI and PET-CT;
- •Signature of inform consent.
排除标准
- •Younger than 18 years old or older than 75 years old;
- •Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma;
- •Extensive stage confirmed by cranial MRI, chest CT, abdominal ultrasonagraph, bone scan or cranial MRI and PET-CT;
- •No signature of inform consent.
结局指标
主要结局
Rate of radiation-induced pneumonitis (CTCAE V4.0)
时间窗: 1 to 2 years
Rate of radiation-induced pneumonitis (CTCAE V4.0)
Rate of radiation-induced esophagitis (CTCAE V4.0)
时间窗: 1 to 2 years
Rate of radiation-induced esophagitis (CTCAE V4.0)
Rate of myelosuppression (CTCAE V4.0)
时间窗: 1 to 2 years
Rate of myelosuppression (CTCAE V4.0)
次要结局
- 2 year locoregional control rate (RECIST 1.1)(2 year)
研究者
Dong Qian
Professor
Anhui Provincial Hospital