Traditional Chinese Medicine Treatment as Adjuvant Therapy in Completely Resected Stage IB-IIIA Non-Small-Cell Lung Cancer: Study Protocol for a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
Traditional Chinese Medicine Treatment as Adjuvant Therapy in Completely Resected Stage IB-IIIA Non-Small-Cell Lung Cancer: Study Protocol for a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
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中医治疗作为完全切除的 IB-IIIA 期非小细胞肺癌的辅助治疗：多中心、双盲、随机、安慰剂对照试验研究方案
DOI：
10.1016/j.cllc.2019.05.011
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发表时间：
2019-09-01
影响因子：
3.6
通讯作者：
Huang, Pin-xian
中科院分区：
文献类型：
--
作者：
Jiang, Yi;Liu, Ling-shuang;Huang, Pin-xian
辅助化疗 (AC) 已被证明可使早期非小细胞肺癌患者的 5 年生存率提高约 5%。由于生存率提高如此之小，最佳治疗方案仍有待确定。在中国，传统中医 (TCM) 治疗与 AC 相结合经常使用。应科学评估这种综合方法的有效性和安全性。我们介绍联合辅助化疗和中药 (ACTCM) 试验 (ChiCTR-IPR-16009062) 的基本原理和研究设计。 ACTCM试验是一项前瞻性多中心双盲随机安慰剂对照研究，将从中国5个临床研究中心总共招募312名患者。在胸外科手术后 6 周内，符合条件的 IB-IIIA 期非小细胞肺癌参与者将以 1:1 的比例随机分配到治疗组或对照组。治疗组患者先接受AC联合中药治疗4个周期，然后中药加注射剂治疗4个周期。对照组患者接受AC联合中药安慰剂4个周期，然后接受中药安慰剂4个周期。如果发生疾病进展或不可接受的毒性，治疗将停止。主要终点是 2 年无病生存率。次要终点包括无病生存和生活质量。其他终点包括中医症状、体能状态和治疗方案的安全性。招聘工作于 2016 年 10 月开始，目前仍在进行中。 (C) 2019 Elsevier Inc. 保留所有权利。
Adjuvant chemotherapy (AC) has been proven to yield an approximately 5% improvement in 5-year survival for patients with early-stage non-small-cell lung cancer. With such small gains in survival, the optimal treatment regimen remains to be established. Traditional Chinese medicine (TCM) treatment in combination with AC is frequently used in China. The efficacy and safety of this integrated approach should be scientifically evaluated. We present the rationale and study design of the Combined Adjuvant Chemotherapy and Traditional Chinese Medicine (ACTCM) trial (ChiCTR-IPR-16009062). The ACTCM trial, a prospective multicenter double-blind randomized placebo-controlled study, will recruit 312 patients overall from 5 clinical research centers in China. Within 6 weeks of the thoracic surgery, eligible participants with stages IB-IIIA non-small-cell lung cancer will be randomly assigned in a 1:1 ratio to either the treatment or control group. Patients in the treatment group will receive AC combined with TCM herbal treatment for 4 cycles, then TCM herbal plus injection treatment for 4 cycles. Patients in the control group will receive AC combined with TCM placebo for 4 cycles and then TCM placebo for 4 cycles. Treatment will be discontinued if disease progression or unacceptable toxicity occurs. The primary end point is 2-year disease-free survival. Secondary end points include disease-free survival and quality of life. Other end points are TCM symptoms, performance status, and safety of the regimens. Recruitment started in October 2016 and is ongoing. (C) 2019 Elsevier Inc. All rights reserved.