Effect of the Plasma EBV DNA Change During Chemoradiotherapy in Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of the Plasma EBV DNA Concentration Change During Chemoradiotherapy on Tumor Control and Patient Survival in Advanced Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Diagnostic Test: Plasma EBV DNA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 5.3 White blood cell count (WBC) ≧ 3,000/micro-ml. 5.4 Platelet count ≧ 100,000/micro-ml. Pre-treatment plasma EBV DNA > 0 copies/mL Signed informed consent. Exclusion Criteria: Presence of distant metastasis. Previous radiotherapy or chemotherapy. 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. Female patients who are pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Plasma EBV DNA|Parameters analyzed will include (1) the change pattern of plasma EBV DNA concentrations, (2) various half-life values (t1/2) of plasma EBV DNA clearance rate calculated over different time periods.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Survival calculation | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | Survival calculation | 2 years | 
| Nasopharynx failure-free survival (NPFFS) | Survival calculation | 2 years | 
| Neck failure-free survival (NFFS) | Survival calculation | 2 years | 
| Distant metastasis failure-free survival (DMFFS) | Survival calculation | 2 years | 
| Tumor response | Tumor response evaluated by image | 2 years | 
| EBV DNA concentration | Plasma EBV DNA by real-time polymerase chain reaction (PCR) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal carcinoma, EBV DNA, Chemoradiotherapy