Clinical trial NCT03087695: Effect of the Plasma EBV DNA Change During Chemoradiotherapy in Nasopharyngeal Carcinoma
Official title: Effect of the Plasma EBV DNA Concentration Change During Chemoradiotherapy on Tumor Control and Patient Survival in Advanced Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
EBV DNA
Chemoradiotherapy
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nasopharyngeal carcinoma patient received definite treatment in Taichung Veteran General Hospital

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

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 2 years
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 2 years
measure: Nasopharynx failure-free survival (NPFFS)
timeFrame: 2 years
measure: Neck failure-free survival (NFFS)
timeFrame: 2 years
measure: Distant metastasis failure-free survival (DMFFS)
timeFrame: 2 years
measure: Tumor response
timeFrame: 2 years
measure: EBV DNA concentration
timeFrame: 2 years
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veteran General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Jin-Ching Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: