Abstract
BackgroundExtensive-stage small-cell lung cancer (ES-SCLC) is characterized by extensive metastases, aggressive progression, and poor prognosis. Chemotherapy is applied as a preferred first-line regimen for ES-SCLC, but inadequate for improving its overall survival. Traditional Chinese medicine (TCM) is widely used in the clinical practice of ES-SCLC for its synergy with chemotherapy. However, there is still no substantial evidence to prove that TCM can effectively improve the long-term efficacy of ES-SCLC patients. The study intends to determine whether the TCM with chemotherapy can improve the overall survival (OS) in treating with ES-SCLC when compared with chemotherapy alone.Method/designA multicenter, randomized, single-blind, placebo-controlled clinical trial will be conducted to determine whether the TCM granules combined with chemotherapy can improve the OS of ES-SCLC. Two hundred seventy participants will randomly receive 4–6 cycles (21 days per cycle) of chemotherapy plus TCM granules or placebo. The primary outcome measure is OS. The secondary outcome measures includes progression-free survival (PFS), objective response rate (ORR), quality of life (QoL), and tumor markers. Visits will be performed at the end of each cycle during the treatment period and then every 3 months in the follow-up period until the patients’ death or study completion.DiscussionThe study’s result will provide a high-level evidence for TCM granules using with chemotherapy on the first-line treatment of ES-SCLC.Trial registrationChinese Clinical Trial Registry ChiCTR1900022991. Registered on 6 May 2019 (prospective registration).
Highlights
Extensive-stage small-cell lung cancer (ES-Small-cell lung cancer (SCLC)) is characterized by extensive metastases, aggressive progression, and poor prognosis
To our knowledge, this is the first multicenter Randomized controlled trial (RCT) aiming at long-term efficacy and prognosis of Traditional Chinese medicine (TCM) granules with chemotherapy in Extensive-stage small-cell lung cancer (ES-SCLC) patients
Despite the lack of stringent design, the above studies have all affirmed the effectiveness of TCM on SCLC, especially in improving quality of life (QoL)
Summary
This is the first multicenter RCT aiming at long-term efficacy and prognosis of TCM granules with chemotherapy in ES-SCLC patients. Apart from the fact that both of their sample sizes were too small to be credible, they all made TCM as the only intervention but ignored the possibilities for patients choosing standard regimens simultaneously, which was not quite consistent with the present treatment status of ES-SCLC in China. Another RCT [18] of 80 SCLC cases demonstrated that TCM decoctions with standard EP could achieve a higher DCR versus EP alone.
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