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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03973723
Other study ID # CG11133
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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