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

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ClinicalTrials.gov Identifier: NCT03087695
Recruitment Status : Unknown
Verified March 2017 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
First Posted : March 22, 2017
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital

Tracking Information
First Submitted Date March 6, 2017
First Posted Date March 22, 2017
Last Update Posted Date March 22, 2017
Estimated Study Start Date April 1, 2017
Estimated Primary Completion Date January 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2017)
Overall survival (OS) [ Time Frame: 2 years ]
Survival calculation
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 16, 2017)
  • Progression free survival (PFS) [ Time Frame: 2 years ]
    Survival calculation
  • Nasopharynx failure-free survival (NPFFS) [ Time Frame: 2 years ]
    Survival calculation
  • Neck failure-free survival (NFFS) [ Time Frame: 2 years ]
    Survival calculation
  • Distant metastasis failure-free survival (DMFFS) [ Time Frame: 2 years ]
    Survival calculation
  • Tumor response [ Time Frame: 2 years ]
    Tumor response evaluated by image
  • EBV DNA concentration [ Time Frame: 2 years ]
    Plasma EBV DNA by real-time polymerase chain reaction (PCR)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of the Plasma EBV DNA Change During Chemoradiotherapy in Nasopharyngeal Carcinoma
Official Title Effect of the Plasma EBV DNA Concentration Change During Chemoradiotherapy on Tumor Control and Patient Survival in Advanced Nasopharyngeal Carcinoma
Brief 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
The patients will be collected blood sample once per week during chemoradiotherapy period. Plasma will be extracted from these blood sample. Plasma EBV DNA concentrations will be measured by a real-time quantitative polymerase chain reaction.
Sampling Method Probability Sample
Study Population Nasopharyngeal carcinoma patient received definite treatment in Taichung Veteran General Hospital
Condition Nasopharyngeal Carcinoma
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 16, 2017)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 16, 2019
Estimated Primary Completion Date January 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03087695
Other Study ID Numbers CF17002B
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No plan to make individual participant data (IPD) available
Responsible Party Taichung Veterans General Hospital
Study Sponsor Taichung Veterans General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jin-Ching Lin, MD, PhD Taichung Veterans General Hospital
PRS Account Taichung Veterans General Hospital
Verification Date March 2017