Omission of Clinical Target Volume (CTV) for Primary Tumors in Limited-Stage Small Cell Lung Cancer: A Prospective Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 852
- 试验地点
- 2
- 主要终点
- Local progression free survival
研究概览
简要总结
This randomized controlled non-inferior trial prospectively enrolled patients with limited-stage small cell lung cancer (LS-SCLC). Patients in the experimental group would receive radiotherapy with omission of the clinical target volume (CTV) for the primary tumor, while those in the control group would receive radiotherapy including CTV. The efficacy and toxicity of the two groups are compared to provide evidence for the radiotherapy of LS-SCLC. The target volume of LS-SCLC may be reduced by omitting CTV without increasing local recurrence but potentially reducing the dose to organs at risk and the side effects.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Small cell lung cancer confirmed by histology or cytology; TNM stage IA-IIIC (AJCC 8th edition, 2017; limited-stage) without intrapulmonary metastasis;
- •Aged 18-75 years, KPS score ≥ 80, ≤ 10% weight loss within the past 6 months;
- •Have measurable lesions per RECIST 1.1 criteria;
- •Have no disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin;
- •Lung function test: FEV1 ≥ 1 L (Optional);
- •Complete blood count: neutrophil count ≥ 1.5 x 10^9/L, hemoglobin ≥ 100 g/L, platelet count ≥ 100 x 10^9/L;
- •Renal function: serum creatinine ≤ 1.5 x upper limit of normal (ULN);
- •Liver function: AST and ALT ≤ 2.5 x ULN, bilirubin ≤ 1.5 x ULN;
- •Fully understand the study, able to complete treatment and follow-up, and voluntarily sign the informed consent.
排除标准
- •Other malignant tumors (prior or concurrent), except those that have been curatively treated with disease-free survival ≥ 5 years, such as non-melanoma skin cancer, cervical carcinoma in situ, or early-stage papillary thyroid cancer;
- •Uncontrolled heart disease or myocardial infarction within the past 6 months;
- •Patients with a history of mental illness;
- •Pregnant and lactating patients;
- •Poorly controlled diabetes and hypertension;
- •Interstitial pneumonia or active pulmonary fibrosis;
- •Active infection;
- •Other conditions unsuitable for enrollment (per investigator judgment).
研究组 & 干预措施
Control group
Creating CTV for primary tumor.
干预措施: Radiation Therapy (Radiation)
Control group
Creating CTV for primary tumor.
干预措施: Etoposide + carboplatin; Etoposide + cisplatin (Drug)
Control group
Creating CTV for primary tumor.
干预措施: prophylactic cranial irradiation (PCI) (Radiation)
Control group
Creating CTV for primary tumor.
干预措施: Creating CTV for primary tumor (Radiation)
Experimental group
Omitting CTV for primary tumor.
干预措施: Radiation Therapy (Radiation)
Experimental group
Omitting CTV for primary tumor.
干预措施: prophylactic cranial irradiation (PCI) (Radiation)
Experimental group
Omitting CTV for primary tumor.
干预措施: Etoposide + carboplatin; Etoposide + cisplatin (Drug)
结局指标
主要结局
Local progression free survival
时间窗: From the date chemotherapy commenced to the first clinical or radiological evidence of progressive disease at the primary site or death, whichever occurs first, to be assessed up to 3 years
Severe toxicity free survival
时间窗: From the date chemotherapy commenced to the first record of serious adverse events related to radiotherapy, to be assessed up to 3 years
次要结局
- Progression free survival(From the date chemotherapy commenced to disease progression or death, whichever occurs first, to be assessed up to 3 years)
- Overall survival(From the date chemotherapy commenced to the date of death from any cause or the end of follow-up at 3 years)
- Number of participants with recurrence or metastasis as evaluated by RECIST 1.1(From the date chemotherapy commenced to the end of follow-up at 3 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(From the date chemotherapy commenced to the end of follow-up at 3 years)
研究者
Shuohan Zheng
Dr.
Sun Yat-sen University