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

March 16, 2017 updated by: Taichung Veterans General Hospital

Effect of the Plasma EBV DNA Concentration Change During Chemoradiotherapy on Tumor Control and Patient Survival in Advanced Nasopharyngeal Carcinoma

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.

Study Overview

Status

Unknown

Conditions

Nasopharyngeal Carcinoma

Intervention / Treatment

Diagnostic test: Plasma EBV DNA

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Taiwan
- - Taichung, Taiwan, 40705
    - Recruiting
    - Taichung Veteran General Hospital
    - Contact:
      
      Jin-Ching Lin, MD, PhD
      
      Phone Number: 5613 +886-4-23592525
      
      Email: jclin@vghtc.gov.tw
    - Contact:
      
      Yi-Chun Liu, MD
      
      Phone Number: 5621 +886-4-23592525
      
      Email: b9202080@gmil.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Nasopharyngeal carcinoma patient received definite treatment in Taichung Veteran General Hospital

Description

Inclusion Criteria:

Histological proven NPC.
2010 American Joint Committee on Cancer (AJCC) stage II-IVB.
Age ≧ 20 years old.
Performance status of Eastern Cooperative Oncology Group (ECOG) ≦ 2.
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.
Pre-treatment plasma EBV DNA > 0 copies/mL
Signed informed consent.

Exclusion Criteria:

Presence of distant metastasis.
Previous radiotherapy or chemotherapy.
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.
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.
Female patients who are pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS) Time Frame: 2 years	Survival calculation	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2017

Primary Completion (Anticipated)

January 16, 2018

Study Completion (Anticipated)

January 16, 2019

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)