Nasopharyngeal CarcinomaNCT03314051
Long-term Treatment Outcome for Stage III NPC Patients and Risk Grouping by Plasma EBV DNA
An observational study of Nasopharyngeal Carcinoma and EBV Related Carcinoma, run by Taichung Veterans General Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, EBV Related Carcinoma
- How many people
- 366 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2012to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Biopsy-proven stage III nasopharyngeal carcinoma (NPC)
- Finished curative chemoradiotherapy
- Have Pre-treatment and post-radiotherapy plasma EBV DNA
Who cannot join
- No tissue proven NPC
- Not finished curative treatment
- No Pre-treatment and post- radiotherapy plasma EBV DNA
About this study
Official title: 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.
Read the 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.
- Conditions
- Nasopharyngeal Carcinoma, EBV Related Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, plasma EBV DNA
- Medical subject headings
- Nasopharyngeal Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Diagnosis to death
Measured: 5 year
Secondary outcomes (3)
Progression-free survival (PFS)
Diagnosis to death to recurrence or metastasis
Measured: 5 year
Distant metastasis failure-free survival (DMFFS)
Diagnosis to death to distant metastasis
Measured: 5 year
Locoregional failure-free survival (LRFFS)
Diagnosis to death to locoregional failure
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start2 May 2012
- Primary completion1 May 2013
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Ching Lin, MD.PhD., Principal investigator, Department of Radiation Oncology, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314051
- Sponsor's protocol ID
- CE12117
- Status last verified
- Oct 2017
- First submitted
- 15 Oct 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Treatment Outcome for Stage III Nasopharyngeal Carcinoma Patients and Risk Grouping by Plasma Epstein-Barr Virus DNA
- ClinicalTrials.gov ID
- NCT03314051
- Acronym / sponsor ID
- CE12117
- Conditions
- Nasopharyngeal Carcinoma, EBV Related Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, plasma EBV DNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 2 May 2012 (actual)
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- Biopsy-proven stage III nasopharyngeal carcinoma (NPC)
- Finished curative chemoradiotherapy
- Have Pre-treatment and post-radiotherapy plasma EBV DNA
Key exclusion criteria (3 listed)
- No tissue proven NPC
- Not finished curative treatment
- No Pre-treatment and post- radiotherapy plasma EBV DNA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: 5 year
Diagnosis to death
3 secondary outcomes
Progression-free survival (PFS)
Time frame: 5 year
Distant metastasis failure-free survival (DMFFS)
Time frame: 5 year
Locoregional failure-free survival (LRFFS)
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Ching Lin, MD.PhD. principal investigator
Department of Radiation Oncology, Taichung Veterans General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma and EBV Related Carcinoma, run by Taichung Veterans General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.