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

Completed

• Conditions: Nasopharyngeal Carcinoma; EBV Related Carcinoma

• Registration Number: NCT03314051
• Lead Sponsor: Taichung Veterans General Hospital

Brief 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.

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 Timeline

• Study Start: 2012-05-02
• Primary Completion: 2013-05-01
• Study Completion: 2016-12-31
• Status Verified: 2017-10
• Study First Submitted: 2017-10-15
• Study First Submitted QC: 2017-10-15
• Last Update Submitted: 2017-10-18
• Study First Posted: 2017-10-19
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	5 year	Diagnosis to death

Secondary Outcome Measures

Name	Time	Method
Locoregional failure-free survival (LRFFS)	5 year	Diagnosis to death to locoregional failure
Progression-free survival (PFS)	5 year	Diagnosis to death to recurrence or metastasis
Distant metastasis failure-free survival (DMFFS)	5 year	Diagnosis to death to distant metastasis