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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03087695
Other study ID # CF17002B
Secondary ID
Status Recruiting
Phase N/A
First received March 6, 2017
Last updated March 16, 2017
Start date April 1, 2017
Est. completion date January 16, 2019

Study information

Verified date March 2017
Source Taichung Veterans General Hospital
Contact Jin-Ching Lin, MD, PhD
Phone +886-4-23592525
Email jclin@vghtc.gov.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date January 16, 2019
Est. primary completion date January 16, 2018
Accepts healthy volunteers
Gender All
Age group 20 Years and older
Eligibility 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


Intervention

Diagnostic Test:
Plasma EBV DNA
Parameters analyzed will include (1) the change pattern of plasma EBV DNA concentrations, (2) various half-life values (t1/2) of plasma EBV DNA clearance rate calculated over different time periods.

Locations

Country Name City State
Taiwan Taichung Veteran General Hospital Taichung

Sponsors (1)

Lead Sponsor Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival (OS) Survival calculation 2 years
Secondary Progression free survival (PFS) Survival calculation 2 years
Secondary Nasopharynx failure-free survival (NPFFS) Survival calculation 2 years
Secondary Neck failure-free survival (NFFS) Survival calculation 2 years
Secondary Distant metastasis failure-free survival (DMFFS) Survival calculation 2 years
Secondary Tumor response Tumor response evaluated by image 2 years
Secondary EBV DNA concentration Plasma EBV DNA by real-time polymerase chain reaction (PCR) 2 years
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