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

• Conditions: Nasopharyngeal Carcinoma

• Registration Number: NCT03087695
• Lead Sponsor: Taichung Veterans 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

Study Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-16
• Last Update Submitted: 2017-03-16
• Study First Posted: 2017-03-22
• Last Update Posted: 2017-03-22
• Study Start: 2017-04-01
• Primary Completion: 2018-01-16
• Study Completion: 2019-01-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	2 years	Survival calculation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taichung Veteran General Hospital; 🇨🇳 Taichung, Taiwan