Nasopharyngeal CarcinomaNCT03973723
Plasma EBV DNA Monitoring in Post-treatment NPC Patients
An observational study of Nasopharyngeal Carcinoma and NPC, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Continuous regular monitoring of plasma EBV DNA in nasopharyngeal carcinoma (NPC) after treatment have rarely been investigated. The investigators try to analyze the long-term observational results (role in early relapse detection and impact on survival) in NPC patients after curative treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma, NPC, EBV
- How many people
- 441 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2011to 30 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with NPC who were treated at 5 hospitals (Taichung Veterans General Hospital, Taichung; Yuan's General Hospital, Kaohsiung; National Cheng Kung University Hospital, Tainan; Kaohsiung Medical University Hospital, Kaohsiung; Taipei Medical University Hospital, Taipei; Taiwan)
Who may be able to join
- histologically-proven nasopharyngeal carcinoma without distant metastasis (M0) at initial presentation
- finished curative radiotherapy (with/without chemotherapy) within 3 years
Who cannot join
- no occurrence of documented recurrence/metastasis before entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Results of Plasma Epstein-Barr Virus DNA Monitoring In Nasopharyngeal Carcinoma After Curative Treatment
Continuous regular monitoring of plasma EBV DNA in nasopharyngeal carcinoma (NPC) after treatment have rarely been investigated. The investigators try to analyze the long-term observational results (role in early relapse detection and impact on survival) in NPC patients after curative treatment.
Read the detailed description
The investigators enrolled 441 NPC patients who had finished finished curative radiotherapy with/without chemotherapy and no recurrence/metastasis before entry this study from five hospitals in Taiwan. Blood samples were collected on the day of enrollment and monitored once every 2-3 months for plasma EBV DNA measurement. After long-term observation, we analyze the impact of continuous plasma EBV DNA monitoring on the early dection of tumor relapse and do risk grouping for survival analyses according to the blood test results.
- Conditions
- Nasopharyngeal Carcinoma, NPC, EBV, Radiotherapy
- Keywords
- Nasopharyngeal Carcinoma, NPC, EBV, Radiotherapy, Plasma Epstein-Barr virus DNA
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with NPC after treatment | All patients with NPC without distant metastases who receiving adequate RT dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time interval from the date of abnormal blood test to the date of clinically documented tumor relapse
From the end of treatment to any time when abnormal blood test is fund
Measured: Five years
Secondary outcomes (2)
Overall survival (OS)
Overall survival was calculated from the day of enrollment until death or the last follow-up visit
Measured: Five years
Event-free survival (EFS)
Event-free survival was calculated from the day of enrollment until the date of first occurrence of tumor relapse (local, regional, or distant failures) or the last follow-up visit
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Aug 2011
- Primary completion31 Dec 2013
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Ching Lin, M.D.,PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973723
- Sponsor's protocol ID
- CG11133
- Status last verified
- Jun 2019
- First submitted
- 3 Jun 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee AW, Poon YF, Foo W, Law SC, Cheung FK, Chan DK, Tung SY, Thaw M, Ho JH. Retrospective analysis of 5037 patients with nasopharyngeal carcinoma treated during 1976-1985: overall survival and patterns of failure. Int J Radiat Oncol Biol Phys. 1992;23(2):261-70. doi: 10.1016/0360-3016(92)90740-9.
PubMed 1587745Jiong L, Berrino F, Coebergh JW. Variation in survival for adults with nasopharyngeal cancer in Europe, 1978-1989. EUROCARE Working Group. Eur J Cancer. 1998 Dec;34(14 Spec No):2162-6. doi: 10.1016/s0959-8049(98)00322-0.
PubMed 10070282Lin JC, Jan JS, Hsu CY, Jiang RS, Wang WY. Outpatient weekly neoadjuvant chemotherapy followed by radiotherapy for advanced nasopharyngeal carcinoma: high complete response and low toxicity rates. Br J Cancer. 2003 Jan 27;88(2):187-94. doi: 10.1038/sj.bjc.6600716.
PubMed 12610501Lin JC, Jan JS, Hsu CY, Liang WM, Jiang RS, Wang WY. Phase III study of concurrent chemoradiotherapy versus radiotherapy alone for advanced nasopharyngeal carcinoma: positive effect on overall and progression-free survival. J Clin Oncol. 2003 Feb 15;21(4):631-7. doi: 10.1200/JCO.2003.06.158.
PubMed 12586799Lin JC, Jan JS, Chen KY, Hsu CY, Liang WM, Wang WY. Outpatient weekly 24-hour infusional adjuvant chemotherapy of cisplatin, 5-fluorouracil, and leucovorin for high-risk nasopharyngeal carcinoma. Head Neck. 2003 Jun;25(6):438-50. doi: 10.1002/hed.10238.
PubMed 12784235Chan AT, Teo PM, Leung TW, Leung SF, Lee WY, Yeo W, Choi PH, Johnson PJ. A prospective randomized study of chemotherapy adjunctive to definitive radiotherapy in advanced nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 1995 Oct 15;33(3):569-77. doi: 10.1016/0360-3016(95)00218-N.
PubMed 7558945Cheng SH, Jian JJ, Tsai SY, Chan KY, Yen LK, Chu NM, Tan TD, Tsou MH, Huang AT. Prognostic features and treatment outcome in locoregionally advanced nasopharyngeal carcinoma following concurrent chemotherapy and radiotherapy. Int J Radiat Oncol Biol Phys. 1998 Jul 1;41(4):755-62. doi: 10.1016/s0360-3016(98)00092-3.
PubMed 9652835International Nasopharynx Cancer Study Group; VUMCA I Trial. Preliminary results of a randomized trial comparing neoadjuvant chemotherapy (cisplatin, epirubicin, bleomycin) plus radiotherapy vs. radiotherapy alone in stage IV(> or = N2, M0) undifferentiated nasopharyngeal carcinoma: a positive effect on progression-free survival. Int J Radiat Oncol Biol Phys. 1996 Jun 1;35(3):463-9. doi: 10.1016/s0360-3016(96)80007-1.
PubMed 8655368
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Results of Plasma Epstein-Barr Virus DNA Monitoring In Nasopharyngeal Carcinoma After Curative Treatment
- ClinicalTrials.gov ID
- NCT03973723
- Acronym / sponsor ID
- CG11133
- Conditions
- Nasopharyngeal Carcinoma, NPC, EBV, Radiotherapy
- Keywords
- Nasopharyngeal Carcinoma, NPC, EBV, Radiotherapy, Plasma Epstein-Barr virus DNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2011 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 4 Jun 2019 (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.
Continuous regular monitoring of plasma EBV DNA in nasopharyngeal carcinoma (NPC) after treatment have rarely been investigated. The investigators try to analyze the long-term observational results (role in early relapse detection and impact on survival) in NPC patients after curative treatment.
Detailed description
The investigators enrolled 441 NPC patients who had finished finished curative radiotherapy with/without chemotherapy and no recurrence/metastasis before entry this study from five hospitals in Taiwan. Blood samples were collected on the day of enrollment and monitored once every 2-3 months for plasma EBV DNA measurement. After long-term observation, we analyze the impact of continuous plasma EBV DNA monitoring on the early dection of tumor relapse and do risk grouping for survival analyses according to the blood test results.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with NPC after treatment | – | –All patients with NPC without distant metastases who receiving adequate RT dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with NPC who were treated at 5 hospitals (Taichung Veterans General Hospital, Taichung; Yuan's General Hospital, Kaohsiung; National Cheng Kung University Hospital, Tainan; Kaohsiung Medical University Hospital, Kaohsiung; Taipei Medical University Hospital, Taipei; Taiwan)
Key inclusion criteria (2 listed)
- histologically-proven nasopharyngeal carcinoma without distant metastasis (M0) at initial presentation
- finished curative radiotherapy (with/without chemotherapy) within 3 years
Key exclusion criteria (1 listed)
- no occurrence of documented recurrence/metastasis before entry
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
Time interval from the date of abnormal blood test to the date of clinically documented tumor relapse
Time frame: Five years
From the end of treatment to any time when abnormal blood test is fund
2 secondary outcomes
Overall survival (OS)
Time frame: Five years
Event-free survival (EFS)
Time frame: Five years
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 7 Jun 2019.
- Background: PubMed 1587745Lee AW, Poon YF, Foo W, Law SC, Cheung FK, Chan DK, Tung SY, Thaw M, Ho JH. Retrospective analysis of 5037 patients with nasopharyngeal carcinoma treated during 1976-1985: overall survival and patterns of failure. Int J Radiat Oncol Biol Phys. 1992;23(2):261-70. doi: 10.1016/0360-3016(92)90740-9.
- Background: PubMed 10070282Jiong L, Berrino F, Coebergh JW. Variation in survival for adults with nasopharyngeal cancer in Europe, 1978-1989. EUROCARE Working Group. Eur J Cancer. 1998 Dec;34(14 Spec No):2162-6. doi: 10.1016/s0959-8049(98)00322-0.
- Background: PubMed 12610501Lin JC, Jan JS, Hsu CY, Jiang RS, Wang WY. Outpatient weekly neoadjuvant chemotherapy followed by radiotherapy for advanced nasopharyngeal carcinoma: high complete response and low toxicity rates. Br J Cancer. 2003 Jan 27;88(2):187-94. doi: 10.1038/sj.bjc.6600716.
- Background: PubMed 12586799Lin JC, Jan JS, Hsu CY, Liang WM, Jiang RS, Wang WY. Phase III study of concurrent chemoradiotherapy versus radiotherapy alone for advanced nasopharyngeal carcinoma: positive effect on overall and progression-free survival. J Clin Oncol. 2003 Feb 15;21(4):631-7. doi: 10.1200/JCO.2003.06.158.
- Background: PubMed 12784235Lin JC, Jan JS, Chen KY, Hsu CY, Liang WM, Wang WY. Outpatient weekly 24-hour infusional adjuvant chemotherapy of cisplatin, 5-fluorouracil, and leucovorin for high-risk nasopharyngeal carcinoma. Head Neck. 2003 Jun;25(6):438-50. doi: 10.1002/hed.10238.
- Background: PubMed 7558945Chan AT, Teo PM, Leung TW, Leung SF, Lee WY, Yeo W, Choi PH, Johnson PJ. A prospective randomized study of chemotherapy adjunctive to definitive radiotherapy in advanced nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 1995 Oct 15;33(3):569-77. doi: 10.1016/0360-3016(95)00218-N.
- Background: PubMed 9652835Cheng SH, Jian JJ, Tsai SY, Chan KY, Yen LK, Chu NM, Tan TD, Tsou MH, Huang AT. Prognostic features and treatment outcome in locoregionally advanced nasopharyngeal carcinoma following concurrent chemotherapy and radiotherapy. Int J Radiat Oncol Biol Phys. 1998 Jul 1;41(4):755-62. doi: 10.1016/s0360-3016(98)00092-3.
- Background: PubMed 8655368International Nasopharynx Cancer Study Group; VUMCA I Trial. Preliminary results of a randomized trial comparing neoadjuvant chemotherapy (cisplatin, epirubicin, bleomycin) plus radiotherapy vs. radiotherapy alone in stage IV(> or = N2, M0) undifferentiated nasopharyngeal carcinoma: a positive effect on progression-free survival. Int J Radiat Oncol Biol Phys. 1996 Jun 1;35(3):463-9. doi: 10.1016/s0360-3016(96)80007-1.
- Individual participant dataSharing planned: No
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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, M.D.,PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma and NPC, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Time interval from the date of abnormal blood test to the date of clinically documented tumor relapse (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973723, which also lists 8 linked publications.
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 7 Jun 2019.