Clinical trial NCT06480903: Exploratory Study of EBV DNA Titre Clearance Whilst on Proton Beam Therapy
Official title: Exploratory Study of Plasma Epstein Barr Virus (EBV) DNA Clearance During Proton Beam Therapy (PBT) for Nasopharyngeal Carcinoma (NPC)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Nasopharyngeal Carcinoma
Head and Neck Cancer
Nasopharyngeal Cancer
Epstein-Barr Virus
Keywords: Nasopharyngeal, cancer, proton beam, epstein-barr virus
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, teenagers and young adults with nasopharyngeal carcinoma (age 8-30 years old)

Brief summary: How does plasma Epstein-Barr Virus (EBV) DNA level change during definitive radiation therapy for nasopharyngeal carcinoma (NPC) in the teenage and young adult cohort and does it correlate with outcomes?

Detailed description: Children with NPC achieve superior survival outcomes compared to adults (10) and the prognostic value of plasma Epstein-Barr Virus (EBV) DNA has not been studied in children. Integration of MRI into early treatment response assessment will add further prognostic value and permits response-adapted therapy which can improve quality of survivorship children through toxicity reduction. It also allows identification of patients who either have had or are likely to have a suboptimal response to treatment, facilitating the potential consideration of treatment escalation.

The sample size of this study is not intended to change clinical practice, but rather provide a basis for international collaboration to achieve larger patient numbers.

Eligibility criteria: Inclusion Criteria:

* Children and young adults (8-30 years old)
* Pathologically confirmed EBV-positive nasopharyngeal carcinoma
* Stage I-IVA (AJCC 8th Edition)
* Planned to commence curative-intent radiation therapy

Exclusion Criteria:

* Recurrent NPC
* Concurrent or previously treated EBV-associated malignancy
* Prior radiation therapy
* Contraindications to MRI
* General anaesthetic requirement for MRI

Primary outcomes:
measure: Plasma EBV during proton beam RT
timeFrame: 6 weeks
Secondary outcomes:
measure: EBV and tumour correlates
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
citation: Twu CW, Wang WY, Liang WM, Jan JS, Jiang RS, Chao J, Jin YT, Lin JC. Comparison of the prognostic impact of serum anti-EBV antibody and plasma EBV DNA assays in nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):130-7. doi: 10.1016/j.ijrobp.2006.07.012. Epub 2006 Sep 18.
citation: Chan AT, Lo YM, Zee B, Chan LY, Ma BB, Leung SF, Mo F, Lai M, Ho S, Huang DP, Johnson PJ. Plasma Epstein-Barr virus DNA and residual disease after radiotherapy for undifferentiated nasopharyngeal carcinoma. J Natl Cancer Inst. 2002 Nov 6;94(21):1614-9. doi: 10.1093/jnci/94.21.1614.
citation: Chan SK, Chan SY, Choi HC, Tong CC, Lam KO, Kwong DL, Vardhanabhuti V, Leung TW, Luk MY, Lee AW, Lee VH. Prognostication of Half-Life Clearance of Plasma EBV DNA in Previously Untreated Non-metastatic Nasopharyngeal Carcinoma Treated With Radical Intensity-Modulated Radiation Therapy. Front Oncol. 2020 Aug 21;10:1417. doi: 10.3389/fonc.2020.01417. eCollection 2020.