Long-term Treatment Outcome for Stage III NPC Patients an... | NCT03314051

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

NCT03314051

Sponsor

Taichung Veterans General Hospital

Status

Completed

Last Update Posted

Oct 20, 2017Actual

Enrollment

366Actual

Phase

Not provided

Conditions

Nasopharyngeal Carcinoma
EBV Related Carcinoma

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2012Actual

Primary Completion Date

May 1, 2013Actual

Completion Date

Dec 31, 2016Actual

First Submitted Date

Oct 15, 2017

First Submission Date that Met QC Criteria

Oct 15, 2017

First Posted Date

Oct 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2017

Last Update Posted Date

Oct 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

366Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival (OS)	Diagnosis to death	5 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin-Ching Lin, MD.PhD.	Department of Radiation Oncology, Taichung Veterans General Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077274	Nasopharyngeal Carcinoma

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided