tReatment Individualisation By EBV stratificatiON in Nasopharyngeal Carcinoma: an Umbrella Platform Study (RIBBON-Umbrella)
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.
⁃ Each patient eligible to participate in this study must meet all the following criteria:
• Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments.
• Age ≥21 years on the day of signing the ICF
• Fulfil one of the following three scenarios:
‣ Suspected NPC cases, diagnosed clinically based on symptoms (neck swelling, unilateral epistaxis, nasal obstruction etc.)
⁃ Newly-diagnosed, histologically confirmed NPC patients with Stages 2-4A disease based on the AJCC/UICC 8th Edition TNM stage classification
⁃ Newly-diagnosed patients with RM-NPC
• All confirmed NPC patients must meet these additional criteria before they can continue participation in the study:
• NPC associated with EBV infection, determined as:
‣ The presence of EBV has been confirmed in the tumour by immunohistochemistry for EBV antigens or in situ hybridization for EBV early RNA (EBER), or
⁃ NPC occurred in association with a raised serum titre of IgA to EBV viral capsid antigen (VCA) or early antigen (EA) in a patient living in endemic area of high incidence of EBV+ undifferentiated NPC, or
⁃ NPC in the context of an elevated circulating EBV genome level
• AJCC 8th edition stage 2-4A or RM NPC based on the following diagnostic workup:
‣ Evaluation of tumour extent with magnetic resonance imaging (MRI) of the nasopharynx and neck. If MRI is medically contraindicated, computed tomography (CT) scan with ≤3 mm and intravenous contrast is acceptable.
⁃ Distant metastasis staging:
• CT scan with contrast of the chest, abdomen, and pelvis or a total body 18F-Fluorodeoxygenase positron emission tomography CT (18F-FDG-PET-CT) scan;
∙ Bone scan, if a 18F-FDG-PET-CT scan is not performed.
• ECOG Performance Status ≤1
• Adequate organ function