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NCT03314051 Clinical Trial

Long-term Treatment Outcome for Stage III NPC Patients and Risk Grouping by Plasma EBV DNA

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Long-term Treatment Outcome for Stage III Nasopharyngeal Carcinoma Patients and Risk Grouping by Plasma Epstein-Barr Virus DNA

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03314051
Other study ID # CE12117
Secondary ID
Status Completed
Phase N/A
First received October 15, 2017
Last updated October 18, 2017
Start date May 2, 2012
Est. completion date December 31, 2016

Study information
Verified date October 2017
Source Taichung Veterans General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

No previous study reported the treatment outcome of stage III nasopharyngeal carcinoma (NPC) patients. The investigators try to investigate the long-term treatment outcome of stage III NPC patients and do risk grouping by plasma Epstein-Barr virus (EBV) DNA assay for future therapy improvement.

Description:

The stage III NPC patients were the majority group of the patient population of NPC. But most clinical trials focused on the treatment of American Joint Committee on Cancer (AJCC) 7th edition stage IVA/IVB treatment for high risk of recurrence or metastasis. No previous study reported the treatment outcome of stage III NPC patients. The investigators tried to investigate the long-term treatment outcome of stage III NPC patients and do risk grouping by plasma EBV DNA assay for future therapy improvement.

Recruitment information / eligibility
Status Completed
Enrollment 366
Est. completion date December 31, 2016
Est. primary completion date May 1, 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Biopsy-proven stage III nasopharyngeal carcinoma (NPC)

- Finished curative chemoradiotherapy

- Have Pre-treatment and post-radiotherapy plasma EBV DNA

Exclusion Criteria:

- No tissue proven NPC

- Not finished curative treatment

- No Pre-treatment and post- radiotherapy plasma EBV DNA

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Taichung Veterans General Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival (OS) Diagnosis to death 5 year
Secondary Progression-free survival (PFS) Diagnosis to death to recurrence or metastasis 5 year
Secondary Distant metastasis failure-free survival (DMFFS) Diagnosis to death to distant metastasis 5 year
Secondary Locoregional failure-free survival (LRFFS) Diagnosis to death to locoregional failure 5 year
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