Plasma EBV DNA Monitoring in Post-treatment NPC Patients

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Long-term Results of Plasma Epstein-Barr Virus DNA Monitoring In Nasopharyngeal Carcinoma After Curative Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03973723
• Other study ID #: CG11133
• Status: Completed
• Start date: August 1, 2011
• Est. completion date: April 30, 2019

Study information

• Verified date: June 2019
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: April 30, 2019
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• EBV
• Nasopharyngeal Carcinoma
• NPC
• Radiotherapy

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Five years
Secondary	Overall survival (OS)	Overall survival was calculated from the day of enrollment until death or the last follow-up visit	Five years
Secondary	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	Five years