Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal carcinoma, EBV DNA, Chemoradiotherapy
Brief summary
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
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
Interventions
DIAGNOSTIC_TESTPlasma 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.
Sponsors
Taichung Veterans General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Inclusion criteria
1. Histological proven NPC. 2. 2010 American Joint Committee on Cancer (AJCC) stage II-IVB. 3. Age ≧ 20 years old. 4. Performance status of Eastern Cooperative Oncology Group (ECOG) ≦ 2. 5. 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. 6. Pre-treatment plasma EBV DNA \> 0 copies/mL 7. Signed informed consent.
Exclusion criteria
1. Presence of distant metastasis. 2. Previous radiotherapy or chemotherapy. 3. 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. 4. 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. 5. Female patients who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 2 years | Survival calculation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasopharynx failure-free survival (NPFFS) | 2 years | Survival calculation |
| Neck failure-free survival (NFFS) | 2 years | Survival calculation |
| Progression free survival (PFS) | 2 years | Survival calculation |
| Tumor response | 2 years | Tumor response evaluated by image |
| EBV DNA concentration | 2 years | Plasma EBV DNA by real-time polymerase chain reaction (PCR) |
| Distant metastasis failure-free survival (DMFFS) | 2 years | Survival calculation |
Countries
Taiwan
Contacts
Primary ContactJin-Ching Lin, MD, PhD
Backup ContactYi-Chun Liu, MD
Outcome results
None listed