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Treatment Individualisation by EBV Stratification in Nasopharyngeal Carcinoma: a Prospective Observational Study

Recruiting
21 - 99 years of age
Both
Phase N/A

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Overview

This is a prospective platform study that will investigate the outcomes of patients with locoregionally-advanced nasopharyngeal carcinoma (LA-NPC) or recurrent-metastatic nasopharyngeal carcinoma (RM-NPC) who are assigned to treatment arms of different chemotherapy sequencing and intensity based on their pre- and on-treatment plasma EBV DNA results.

Description

The primary objectives of this platform are: (1) to prospectively validate the prognostic potential of an EBV DNA-based risk-stratification strategy of patients with LA- and RM-NPC; and (2) to test if treatment individualization strategies based on pre- and on-treatment plasma EBV DNA will improve survival outcomes. Primary study end-point is 2-year disease-free survival (DFS).

Eligibility

Inclusion Criteria:

Any patients ≥21 years of age with any of the following:

  1. Suspected NPC cases, diagnosed clinically based on symptoms (neck swelling, unilateral epistaxis, nasal obstruction etc.)
  2. Newly-diagnosed, histologically confirmed NPC patients with Stages 2-4A disease based on the AJCC/UICC 8th Edition TNM stage classification
  3. Newly-diagnosed patients with RM-NPC

Exclusion Criteria:

All patients <21 years or >99 years old will be excluded from participation.

Study details

Nasopharyngeal Carcinoma

NCT05517135

National Cancer Centre, Singapore

25 January 2024

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