The Value of Post-radiation Detectable Plasma EBV DNA in High-risk Nasopharyngeal Carcinoma Patients

Completed

• Conditions: Nasopharyngeal Carcinoma

• Registration Number: NCT03981224
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

An additional blood test at 2-3 months after RT is a valuable biomarker in predicting treatment outcome for NPC patients. Patients with persistently detectable EBV DNA during re-staging survey 2-3 months after RT should strengthen adjuvant therapy due to very high subsequent relapse rate and poor survivals.

Detailed Description

One week post-radiation therapy (RT) blood test showing persistently detectable EBV DNA is a very poor prognostic factor for nasopharyngeal carcinoma (NPC) patients. We hypothesize that additional EBV DNA confirmation test could enhance diagnostic sensitivity of relapse detection and predict survivals.

We screened 706 newly diagnosed NPC patients who finished curative RT with or without chemotherapy from March 2001 to December 2012. Additional EBV DNA blood test was performed at re-staging survey 2-3 months after RT. The association between treatment outcome (tumor relapse and patients' survival) and this additional blood test along with various clinical parameters were analyzed.

Study Timeline

• Study Start: 2012-05-02
• Primary Completion: 2013-05-01
• Study Completion: 2013-05-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-06
• Last Update Submitted: 2019-06-06
• Study First Posted: 2019-06-10
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 706

Inclusion Criteria

• histologically-proven nasopharyngeal carcinoma without distant metastasis (M0) at initial presentation
• NPC patients who finished curative RT with or without chemotherapy

Exclusion Criteria

• initial present M1 disease
• Secondary primary cancer diagnosed within 5 years
• performance status (WHO scale) less than 2

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
relapse-free survival (RFS)	5 years	From the end of treatment to clinical or pathological proven disease relapse

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	5 years	Overall survival was calculated from the day of enrollment until death or the last follow-up visit