Clinical trial NCT03973723: Plasma EBV DNA Monitoring in Post-treatment NPC Patients
Official title: Long-term Results of Plasma Epstein-Barr Virus DNA Monitoring In Nasopharyngeal Carcinoma After Curative Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasopharyngeal Carcinoma
NPC
EBV
Radiotherapy
Keywords: Nasopharyngeal Carcinoma
NPC
EBV
Radiotherapy
Plasma Epstein-Barr virus DNA
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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)

Brief 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.

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.

Eligibility criteria: Inclusion criteria

* histologically-proven nasopharyngeal carcinoma without distant metastasis (M0) at initial presentation
* finished curative radiotherapy (with/without chemotherapy) within 3 years

Exclusion criteria

* no occurrence of documented recurrence/metastasis before entry

Primary outcomes:
measure: Time interval from the date of abnormal blood test to the date of clinically documented tumor relapse
timeFrame: Five years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Five years
measure: Event-free survival (EFS)
timeFrame: Five years
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Jin-Ching Lin, M.D.,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Jiong 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.
citation: Lin 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.
citation: Lin 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.
citation: Lin 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.
citation: Chan 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.
citation: Cheng 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.
citation: International 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.