Plasma EBV DNA Monitoring in Post-treatment NPC Patients

NCT03973723 | Completed DMC

• 1 other identifier: CG11133
• Study Type: observational
• Target: 441
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma; NPC; EBV; Radiotherapy

Keywords

Nasopharyngeal Carcinoma; NPC; EBV; Radiotherapy; Plasma Epstein-Barr virus DNA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall survival (OS)

  Five years

• Event-free survival (EFS)

  Five years

Study Arms (1)

Patients with NPC after treatment

All patients with NPC without distant metastases who receiving adequate RT dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• no occurrence of documented recurrence/metastasis before entry

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

Related Publications (8)

• 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.

  PMID: 1587745 BACKGROUND

• 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.

  PMID: 10070282 BACKGROUND

• 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.

  PMID: 12610501 BACKGROUND

• 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.

  PMID: 12586799 BACKGROUND

• 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.

  PMID: 12784235 BACKGROUND

• 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.

  PMID: 7558945 BACKGROUND

• 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.

  PMID: 9652835 BACKGROUND

• 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.

  PMID: 8655368 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and check plasma EBV DNA

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jin-Ching Lin, M.D.,PhD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 4, 2019
• Study Start: August 1, 2011
• Primary Completion: December 31, 2013
• Study Completion: April 30, 2019
• Last Updated: June 7, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)