Actively Recruiting
tReatment Individualisation By EBV stratificatiON in Nasopharyngeal Carcinoma: an Umbrella Platform Study (RIBBON-Umbrella)
Led by National Cancer Centre, Singapore · Updated on 2024-09-19
1000
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
tReatment Individualisation By EBV stratificatiON in Nasopharyngeal Carcinoma: an Umbrella Platform Study (RIBBON-Umbrella)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and comply with study requirements
- Age 21 years or older at the time of consent
- Meets one of the following: suspected NPC based on symptoms; newly diagnosed, histologically confirmed NPC stages 2-4A; or newly diagnosed recurrent-metastatic NPC
- NPC associated with EBV infection confirmed by tumor testing or elevated EBV markers in blood
- AJCC 8th edition stage 2-4A or recurrent-metastatic NPC confirmed by imaging including MRI or CT and metastasis staging
- ECOG performance status of 1 or better
- Adequate organ function
You will not qualify if you...
- Age younger than 21 years or older than 99 years
- Prior radiation therapy or systemic anti-cancer therapy including investigational agents not part of planned NPC treatment
- Known central nervous system metastases or carcinomatous meningitis
- Active malignancy within 2 years before study start, except treated local cancers
- Severe chronic or active infections requiring systemic treatment, including tuberculosis
- Untreated chronic hepatitis B with high viral load or active hepatitis C infection
- Prior allogeneic stem cell or organ transplantation
- Recent cardiovascular events or conditions limiting daily activities within 28 days before study
- History of severe allergic reactions to study chemotherapy drugs or their components
- Use of herbal medicines for cancer control within 14 days before study
- Unrecovered or unstable toxicities from previous cancer treatment except minor adverse events
- Medical conditions or substance abuse that could impair treatment or study compliance
- Participation in another therapeutic clinical study concurrently
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Centre Singapore
Singapore, Singapore, 168583
Actively Recruiting
Research Team
M
Melvin Lee Kiang Chua, MBBS, FRCR, PhD, FAMS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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