Evidence map›Paper›PMID 25873045›Full record

Trial reportTrials2015

Fuzheng Kang'ai decoction combined with gefitinib in advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations: study protocol for a randomized controlled trial.

Xiao-Bing Yang, Wan-Yin Wu, Shun-Qin Long, Hong Deng, Zong-Qi Pan, Wen-Feng He, Yu-Shu Zhou, Gui-Ya Liao, Qiu-Ping Li, Shu-Jing Xiao and 1 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Cell-Free Circulating Tumour DNA Blood Testing to DetectOntario health technology assessment series · 2020
    Article
  7. Article
  8. Review
  9. In Vitro and In Vivo Inhibitory Effect of Gujin Xiaoliu Tang in Non-Small Cell Lung Cancer.Evidence-based complementary and alternative medicine : eCAM · 2018
    Article
  10. Article
  11. Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Xiao-Bing YangDepartment of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. yangxiaobing2002@126.com.
Wan-Yin WuDepartment of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. wwanyin@126.com.
Shun-Qin LongDepartment of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. thinkinglong@126.com.
Hong DengDepartment of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. denghong163@126.com.
Zong-Qi PanDepartment of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. flypzq@126.com.
Wen-Feng HeDepartment of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. hwfzll@126.com.
Yu-Shu ZhouDepartment of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. 20387493@qq.com.
Gui-Ya LiaoDepartment of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. liaoguiya_ya@126.com.
Qiu-Ping LiDepartment of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. liqiupinga@163.com.
Shu-Jing XiaoDepartment of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. shujing-020@163.com.
Jiao-Zhi CaiDepartment of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. Caijiaozhi@163.com.
Guangdong Provincial Hospital of Traditional Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with advanced non-small cell lung cancer (NSCLC) harboring mutations of the epidermal growth factor receptor (EGFR) gene respond well to the EGFR tyrosine kinase inhibitor (TKI) gefitinib. Chinese herbal medicine (CHM) has been used as a complementary therapy for cancer for decades in China. CHM was proved to be effective in improving the quality of life (QOL) and reducing the toxicity associated with chemotherapy in patients with NSCLC. The purpose of the present trial is to determine whether CHM (Fuzheng Kang'ai decoction (FZKA), a CHM formula) combined with gefitinib results in longer progression-free survival with less toxicity than gefitinib alone. METHODS/

designThis is a randomized, placebo-controlled, double-blind trial. This trial is designed to determine if CHM (FZKA) combined with gefitinib results in longer progression-free survival with less toxicity than gefitinib alone. A total of 70 NSCLC patients with EGFR mutations will be randomly assigned to treatment group (gefitinib plus FZKA granules) or control group (gefitinib plus placebo). The primary endpoint is progression-free survival. Secondary endpoints are: (1) overall survival; (2) disease control rate; (3) QOL, measured with the questionnaire of Functional Assessment of Cancer Therapy-lung (FACT-L 4.0) and Lung Cancer Symptom Scale and (4) safety. DISCUSSION: In previous clinical practice, we found that CHM (FZKA) could improve the therapeutic efficacy of gefitinib. This study will provide objective evidence to evaluate the efficiency of CHM combined with gefitinib in NSCLC patients with EGFR mutations, and may provide a novel regimen for patients with NSCLC.

trial registrationChinese Clinical Trial Registry ( www.chictr.org ): ChiCTR-IOR-14005679 , registered 17 December 2014.

Indexed as

MutationAdolescentAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Non-Small-Cell LungChinaClinical ProtocolsDisease-Free SurvivalDisease ProgressionDNA Mutational AnalysisDouble-Blind MethodDrugs, Chinese HerbalErbB ReceptorsBiomarkers, TumorDrugs, Chinese HerbalEGFR protein, humanErbB Receptorsfuzheng kang'aiGefitinibProtein Kinase InhibitorsQuinazolines

Identifiers

PMID25873045
PMCPMC4396173
OpenAlexW2153048714

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.