tReatment Individualisation By EBV stratificatiON in Nasopharyngeal Carcinoma: an Umbrella Platform Study (RIBBON-Umbrella)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 99
View:

⁃ 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

Locations
Other Locations
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
Contact Information
Primary
Melvin Lee Kiang Chua, MBBS, FRCR, PhD, FAMS
melvin.chua.l.k@singhealth.com.sg
64368000
Time Frame
Start Date: 2022-11-17
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 1000
Treatments
Arm 1
Arm 1: Pre-treatment EBV DNA \<4000 copies/mL AND N0-1 or T4N0 (TNM AJCC/UICC 8th edition)
Arm 2
Arm 2: Pre-treatment EBV DNA ≥4000 copies/mL OR N2-N3 OR T4N+ (TNM AJCC/UICC 8th edition) AND EBV DNA UNDETECTABLE after 2-3 cycles of induction chemotherapy (IC)
Arm 3
Arm 3: Pre-treatment EBV DNA ≥4000 copies/mL OR N2-N3 OR T4N+ (TNM AJCC/UICC 8th edition) AND EBV DNA DETECTABLE after 2-3 cycles of IC
Group 1
Group 1: Recurrent/metastatic NPC, EBV DNA \<4000 copies/mL
Group 2
Group 2: Recurrent/metastatic NPC, EBV DNA ≥4000 copies/mL
Related Therapeutic Areas
Sponsors
Leads: National Cancer Centre, Singapore

This content was sourced from clinicaltrials.gov