NCT02476669

Brief Summary

Nasopharyngeal carcinoma (NPC) is an endemic malignancy in Southern China, Hong Kong, Taiwan, Singapore and Malaysia. It is highly associated with Epstein-Barr virus (EBV). Radiation therapy alone is indicated for early stage I to II diseases while concurrent chemoradiation is required for more advanced stage III to IVB diseases. Intensity-modulated radiation therapy (IMRT) is the standard radiation technique for NPC, in virtue of its superior target coverage and dose sparing to adjacent critical organs-at-risks. Plasma EBV DNA and other novel plasma biomarkers have been extensively investigated in NPC. Previous studies have proven their predictive and prognostic values in NPC diagnosis, surveillance and survival outcomes. We would like to investigate the roles of plasma biomarkers including plasma EBV DNA on treatment response evaluation, survival and prognosis on NPC, in the modern era of precision radiation therapy. This will provide important information on refining on the current edition of AJCC/UICC staging classification.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

10.5 years

First QC Date

June 16, 2015

Last Update Submit

August 11, 2020

Conditions

Nasopharyngeal Carcinoma

Keywords

plasma EBV DNAbiomarkerintensity-modulated radiation therapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival is calculated from the date of diagnosis of NPC to the date of death from any cause

    3 years

Secondary Outcomes (5)

  • Cancer-specific survival

    3 years

  • Progression-free survival

    3 years

  • Distant metastasis-free survival

    3 years

  • Regional failure-free survival

    3 years

  • Local failure-free survival

    3 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with histologically confirmed previously untreated nasopharyngeal carcinoma (NPC) will be invited to join this study.

You may qualify if:

  • Patients with histologically confirmed previously untreated nasopharyngeal carcinoma

You may not qualify if:

  • Patients who are pregnant or lactating
  • Patients who are not mentally capable of giving written informed consent
  • Patients with performance status ECOG=3 or above or patients who are expected not able to tolerate radiation therapy and/or chemotherapy
  • Patients who refuse active treatment for their nasopharyngeal carcinoma
  • Patients who cannot comply with radiation therapy and/or chemotherapy for their nasopharyngeal carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Oncology, Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • Nicholls JM, Lee VH, Chan SK, Tsang KC, Choi CW, Kwong DL, Lam KO, Chan SY, Tong CC, So TH, Leung TW, Luk MY, Khong PL, Lee AW. Negative plasma Epstein-Barr virus DNA nasopharyngeal carcinoma in an endemic region and its influence on liquid biopsy screening programmes. Br J Cancer. 2019 Oct;121(8):690-698. doi: 10.1038/s41416-019-0575-6. Epub 2019 Sep 17.

    PMID: 31527689DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Victor Lee, FRCR

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Lee, FRCR

CONTACT

852-2255-4352vhflee@hku.hk

Ka-On Lam, FRCR

CONTACT

852-2255-4352lamkaon@hku.hk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant |Professor

Study Record Dates

First Submitted

June 16, 2015

First Posted

June 19, 2015

Study Start

June 1, 2010

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations

HK(1)