A Randomized Phase II Trial of Etoposide Plus Lobaplatin Versus Etoposide Plus Cisplatin in Combination With Concurrent Thoracic Radiotherapy for Patients With Limited Small-cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Progression-free survival(PFS)
研究概览
简要总结
This randomized phase II study compare survival outcomes and toxicity of two chemotherapy regimens (etoposide plus lobaplatin or etoposide plus cisplatin) in combination with concurrent thoracic radiation therapy (TRT) for limited stage small cell lung cancer.
详细描述
Lobaplatin is a platinum complex with DNA alkylating activity that was developed by ASTA Medica (Degussa) for the treatment of cancer. Lobaplatin as the third-generation platinum antineoplastic agent, showed promising antineoplastic effects in variety of preclinical test tumor models. A randomized, multicenter phase III study showed that Lobaplatin plus etoposide (EL) regimen is not inferiority to cisplatin plus etoposide (EP) regimen in terms of PFS, the tolerance and QOL with EL regimen are better than that with EP regimen. Thus, we perform this study was to compare the efficacy and safety of EL and EP regimens concurrently with thoracic radiotherapy in patients with limited-stage SCLC.
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
- •Histologically or cytologically confirmed SCLC
- •Newly diagnosed SCLC
- •Either sex, age between 18 to 75 years
- •Limited stage: AJCC (8th edition) Stage I-III (T any, N any, M0) that can be safely treated with definitive radiation doses. Excludes T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
- •Performance status ECOG grade 0-
- •Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator. Patients with PS 2 as a result of comorbid conditions will be excluded.
- •Adequate bone marrow, liver and renal function as defined below:neutrophils ≥ 1.5 × 109/L, platelets 80 × 109/L, hemoglobin ≥80 g/L, AST and ALT ≤2× the upper limit of the institutional normal range, total bilirubin ≤1.25× the upper limit of the institutional normal range, and creatinine concentration ≤120 μmol/L
- •No history of thoracic surgery, radiation therapy, or chemotherapy
- •Had measurable or assessable disease
排除标准
- •Pregnancy or lactation at the time of enrollment
- •Previous malignancy or other concomitant malignant disease
- •Malignant pleural or pericardial effusions
研究组 & 干预措施
Etoposide plus Lobaplatin group
Chemotherapy:etoposide plus lobaplatin (EL)
干预措施: etoposide plus lobaplatin (Drug)
Etoposide plus Cisplatin group
Chemotherapy:etoposide plus cisplatin (EP)
干预措施: etoposide plus cisplatin (Drug)
结局指标
主要结局
Progression-free survival(PFS)
时间窗: up to 12 months
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
次要结局
- Treatment toxicities(up to 12 months)
- Overall survival(OS)(up to 24 months)
研究者
ShengFa Su
Professor
Guizhou Medical University