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.
Trials
; 16: 146, 2015 Apr 10.
Article
en En
| MEDLINE
| ID: mdl-25873045
ABSTRACT
BACKGROUND:
Patients 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/DESIGN:
This 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 REGISTRATION Chinese Clinical Trial Registry ( www.chictr.org ) ChiCTR-IOR-14005679 , registered 17 December 2014.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Quinazolinas
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Medicamentos Herbarios Chinos
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Protocolos de Quimioterapia Combinada Antineoplásica
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Biomarcadores de Tumor
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Carcinoma de Pulmón de Células no Pequeñas
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Inhibidores de Proteínas Quinasas
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Receptores ErbB
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Neoplasias Pulmonares
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Mutación
Tipo de estudio:
Clinical_trials
/
Guideline
Límite:
Aged80
País/Región como asunto:
Asia
Idioma:
En
Revista:
Trials
Asunto de la revista:
MEDICINA
/
TERAPEUTICA
Año:
2015
Tipo del documento:
Article
País de afiliación:
China