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

October 18, 2017 updated by: Taichung Veterans General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

366

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Tissue proven stage III NPC patients and received curative treatment in our institute. Pre-treatment and post-radiotherapy plasma EBV DNA will be obtained.

Description

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 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: 5 year
Diagnosis to death
5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 5 year
Diagnosis to death to recurrence or metastasis
5 year
Distant metastasis failure-free survival (DMFFS)
Time Frame: 5 year
Diagnosis to death to distant metastasis
5 year
Locoregional failure-free survival (LRFFS)
Time Frame: 5 year
Diagnosis to death to locoregional failure
5 year

Collaborators and Investigators

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

Sponsor

Taichung Veterans General Hospital

Investigators

  • Principal Investigator: Jin-Ching Lin, MD.PhD., Department of Radiation Oncology, 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 (Actual)

May 2, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

October 15, 2017

First Submitted That Met QC Criteria

October 15, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE12117

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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