Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-24 @ 10:03 PM
NCT ID:
NCT05517135
Brief Summary:
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.
Detailed 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.
For LA-NPC, the study design consists of two components: (1) to allocate adult patients with UICC/AJCC 8th edition TNM-stage 2-4A LA-NPC to 3 treatment arms of different intensities by their plasma EBV DNA levels pre-treatment and post-induction chemotherapy (IC); and (2) to incorporate open-label, single-arm, phase 2 trials within the platform for patients who are deemed to be at high-risk of relapse, defined by a persistently detectable EBV DNA following 3 cycles of IC. Primary study end-point is 2-year disease-free survival (DFS).
Study:
NCT05517135
Study Brief:
Protocol Section:
NCT05517135