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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Additional Blood Test Enhances Diagnostic Sensitivity of Relapse Detection and Predicts Survivals in High-risk Nasopharyngeal Carcinoma Patients With Post-radiation Detectable Plasma EBV DNA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03981224
• Other study ID #: CE12117-1
• Status: Completed
• Start date: May 2, 2012
• Est. completion date: May 1, 2013

Study information

• Verified date: June 2019
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 706
• Est. completion date: May 1, 2013
• Est. primary completion date: May 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	locoregional failure-free survival (LRFFS)	locoregional failure-free survival was calculated from the day of enrollment until locoregional failure or the last follow-up visit	5 years
Other	distant metastasis failure-free survival (DMFFS)	distant metastasis failure-free survival was calculated from the day of enrollment until distant metastasis or the last follow-up visit	5 years
Primary	relapse-free survival (RFS)	From the end of treatment to clinical or pathological proven disease relapse	5 years
Secondary	Overall survival (OS)	Overall survival was calculated from the day of enrollment until death or the last follow-up visit	5 years