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中药辅助治疗完全切除的 IB 期-IIIA 期非小细胞肺癌:一项多中心、双盲、随机、安慰剂对照试验的研究方案。

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.

机构信息

Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

出版信息

Clin Lung Cancer. 2019 Sep;20(5):e541-e547. doi: 10.1016/j.cllc.2019.05.011. Epub 2019 May 21.


DOI:10.1016/j.cllc.2019.05.011
PMID:31230892
Abstract

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.

摘要

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%。由于生存获益如此之小,最佳治疗方案仍有待确定。中药(TCM)联合 AC 治疗在中国经常使用。这种综合治疗方法的疗效和安全性应进行科学评估。我们介绍了联合辅助化疗和中药(ACTCM)试验(ChiCTR-IPR-16009062)的原理和研究设计。ACTCM 试验是一项前瞻性、多中心、双盲、随机对照研究,将在中国 5 个临床研究中心共招募 312 名患者。在胸部手术后 6 周内,将符合条件的 IB-IIIA 期非小细胞肺癌患者以 1:1 的比例随机分为治疗组和对照组。治疗组患者将接受 AC 联合 TCM 草药治疗 4 个周期,然后接受 TCM 草药加注射治疗 4 个周期。对照组患者将接受 AC 联合 TCM 安慰剂治疗 4 个周期,然后接受 TCM 安慰剂治疗 4 个周期。如果出现疾病进展或无法耐受的毒性,将停止治疗。主要终点是 2 年无病生存率。次要终点包括无病生存率和生活质量。其他终点是 TCM 症状、表现状态和方案的安全性。招募工作于 2016 年 10 月开始,目前正在进行中。

相似文献

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