Abstract
PurposeClinical Trials have emerged as the main force in driving the development of medicine. However, little is known about the current status of clinical trials regarding nasopharyngeal carcinoma (NPC). This study aimed at providing a comprehensive landscape of NPC-related trials on the basis of ClinicalTrials.gov database.Patients and methodsWe used the keyword “nasopharyngeal carcinoma” to search the ClinicalTrials.gov database and assessed the characteristics of these trials.ResultsUp to December 30, 2016, 462 eligible trials in total were identified, of which 222 (48.0%) recruited only NPC (NPC trials) and the other 240 (52.0%) recruited both NPC and other cancers (multiple cancer trials). Moreover, 47 (10.2%) were Epstein-Barr virus (EBV)-related trials and 267 (57.8%) focused on metastatic/recurrent disease. Compared with NPC trials, the multiple cancer trials had a higher percentage of phase 1 (26.7% vs. 6.7%, P < 0.001) studies and more patients with metastatic/recurrent disease (72.5% vs. 41.9%, P < 0.001). Notably, non-EBV trials had more phase 2 or 3 (78.4% vs. 48.8%, P < 0.001) and interventional studies (89.5% vs. 70.7%, P = 0.002) than EBV trials. Obviously, more phase 2/3 or 3 trials were conducted in patients with non-metastatic/recurrent disease (29.4% vs. 4.9%, P < 0.001); however, metastatic/recurrent trials were more likely to be anticancer (94.6% vs. 63.6%, P < 0.001).ConclusionsThe role of plasma EBV DNA in clinical trials is underestimated, and high-level randomized clinical trials should be performed for patients with metastatic/recurrent disease.
Highlights
Nasopharyngeal carcinoma (NPC) differs from other head and neck cancers for its epidemiology, clinical characteristics and therapy modality; it has an incidence rate of 20 per 100,000 persons in endemic regions such as South East Asia and Southern China [1], and radiotherapy has come as the only curative treatment as a result of the anatomic constraints and its sensitivity to irradiation
Compared with NPC trials, the multiple cancer trials had a higher percentage of phase 1 (26.7% vs. 6.7%, P < 0.001) studies and more patients with metastatic/recurrent disease (72.5% vs. 41.9%, P < 0.001)
The role of plasma Epstein-Barr virus (EBV) DNA in clinical trials is underestimated, and high-level randomized clinical trials should be performed for patients with metastatic/recurrent disease
Summary
Nasopharyngeal carcinoma (NPC) differs from other head and neck cancers for its epidemiology, clinical characteristics and therapy modality; it has an incidence rate of 20 per 100,000 persons in endemic regions such as South East Asia and Southern China [1], and radiotherapy has come as the only curative treatment as a result of the anatomic constraints and its sensitivity to irradiation. In September 2004, a consensus has been reached by the International Committee of Medical Journal Editors (ICMJE) that clinical trials should be registered in a public registry before recruiting patients to ensure transparency of the whole process. Later on, this policy was applied to all the clinical trials starting recruitment after July 1, 2005 [7]. ClinicalTrials.gov, developed and maintained by National Library of Medicine (NLM), is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The ClinicalTrials.gov provides the most comprehensive source of information on ongoing and completed clinical studies worldwide
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