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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03087695
• Other study ID #: CF17002B
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

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