Wang Xue-Qian, Liu Jie, Lin Hong-Sheng, Hou Wei
Oncology Department of Guang'anmen Hospital, Affiliated to China Academy of Chinese Medical Sciences, No. 5, Bei Xian-ge Road, Xi Cheng District, Beijing, 100053, China.
Beijing University of Chinese Medicine, No. 11, East Road North 3rd Ring Road, Chao Yang District, Beijing, 100029, China.
Trials. 2016 Mar 8;17(1):124. doi: 10.1186/s13063-016-1231-6.
BACKGROUND: With the aging of the global population, an increasing number of elderly are diagnosed with advanced non-small cell lung cancer. Although systematic chemotherapy has been one of the primary treatments for advanced non-small cell lung cancer worldwide, the elderly cannot always tolerate standard platinum-based doublet chemotherapy, thus resulting in treatment failure. To reduce toxicity, single-agent chemotherapy is often used to treat the elderly with non-small cell lung cancer; however, this may increase the risk of treatment failure due to an inadequate dose. It has been shown that compound kushen injection in combination with chemotherapy can enhance the efficacy and reduce the toxicity. The aim of this trial is to assess the clinical effectiveness and safety of compound kushen injection in combination with single-agent chemotherapy versus platinum-based doublet chemotherapy in the treatment of elderly patients with advanced non-small cell lung cancer. METHODS: This multicenter study will be an open-label, randomized controlled trial. Three hundred seventy elderly patients with advanced non-small cell lung cancer will be randomly divided into experimental (n = 185) and control groups (n = 185) to receive compound kushen injection in combination with single-agent chemotherapy or standard platinum-based doublet chemotherapy for two cycles. After two cycles, the disease control rate, objective response rate, clinical symptoms, quality of life, Karnofsky Performance Status, and side effects will be assessed. Follow-up evaluations will be performed every 8 weeks to evaluate the progression-free and overall survival. DISCUSSION: Before the trial was designed, compound kushen injection was shown to be effective for lung cancer through basic experiments and clinical trials. This study will determine whether or not the efficacy of compound kushen injection in combination with single-agent chemotherapy is comparable to that of platinum-based doublet chemotherapy, and whether or not the toxicity of compound kushen injection in combination with single-agent chemotherapy is lower than that of platinum-based doublet chemotherapy. TRIAL REGISTRATION: ChiCTR-IPR-14005484 (16 November 2014).
背景：随着全球人口老龄化，越来越多的老年人被诊断为晚期非小细胞肺癌。尽管系统化疗一直是全球晚期非小细胞肺癌的主要治疗方法之一，但老年人往往无法耐受标准的铂类双联化疗，从而导致治疗失败。为降低毒性，单药化疗常被用于治疗老年非小细胞肺癌患者；然而，这可能会因剂量不足而增加治疗失败的风险。研究表明，复方苦参注射液联合化疗可提高疗效并降低毒性。本试验的目的是评估复方苦参注射液联合单药化疗与铂类双联化疗治疗老年晚期非小细胞肺癌患者的临床有效性和安全性。 方法：本多中心研究将是一项开放标签的随机对照试验。370例老年晚期非小细胞肺癌患者将被随机分为试验组（n = 185）和对照组（n = 185），接受复方苦参注射液联合单药化疗或标准铂类双联化疗两个周期。两个周期后，评估疾病控制率、客观缓解率、临床症状、生活质量、卡氏功能状态评分及副作用。每8周进行一次随访评估，以评估无进展生存期和总生存期。 讨论：在设计本试验之前，基础实验和临床试验已表明复方苦参注射液对肺癌有效。本研究将确定复方苦参注射液联合单药化疗的疗效是否与铂类双联化疗相当，以及复方苦参注射液联合单药化疗的毒性是否低于铂类双联化疗。 试验注册：ChiCTR-IPR-14005484（2014年11月16日）。
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