Effect of the Plasma EBV DNA Change During Chemoradiotherapy in Nasopharyngeal Carcinoma
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ClinicalTrials.gov Identifier: NCT03087695
Recruitment Status : Unknown
Verified March 2017 by Taichung Veterans General Hospital. Recruitment status was: Recruiting
Epstein-Barr virus (EBV) has been proven to process a strong association in patient of nasopharyngeal carcinoma (NPC). Monitoring plasma EBV DNA in NPC patients can provide reliable informations in early detecting tumor recurrence or risk grouping.
Condition or disease
Diagnostic Test: Plasma EBV DNA
EBV DNA has strongly association in NPC patient' disease status. It can provide informations of disease relapse or risks classification. In this study, we will investigate the impact of plasma EBV DNA concentration change during chemoradiotherapy on initial tumor response and long-term survival in patients with advanced nasopharyngeal carcinoma
Progression free survival (PFS) [ Time Frame: 2 years ]
Nasopharynx failure-free survival (NPFFS) [ Time Frame: 2 years ]
Neck failure-free survival (NFFS) [ Time Frame: 2 years ]
Distant metastasis failure-free survival (DMFFS) [ Time Frame: 2 years ]
Tumor response [ Time Frame: 2 years ]
Tumor response evaluated by image
EBV DNA concentration [ Time Frame: 2 years ]
Plasma EBV DNA by real-time polymerase chain reaction (PCR)
Biospecimen Retention: Samples With DNA
The patients will be collected blood sample once per week during chemoradiotherapy period. Plasma will be extracted from these blood sample. Plasma EBV DNA concentrations will be measured by a real-time quantitative polymerase chain reaction.
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Layout table for eligibility information
Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Nasopharyngeal carcinoma patient received definite treatment in Taichung Veteran General Hospital
Histological proven NPC.
2010 American Joint Committee on Cancer (AJCC) stage II-IVB.
Age ≧ 20 years old.
Performance status of Eastern Cooperative Oncology Group (ECOG) ≦ 2.
Adequate liver, renal, and bone marrow functions 5.1 Serum total bilirubin level ≦ 2.5 mg/dl. 5.2 Serum creatinine ≦ 1.6 mg/dl or calculated creatinine clearance rate (CCr) ≧ 60 cc/min.
History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast.
Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.