RecruitingNCT05517135

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

Sponsor

National Cancer Centre, Singapore

Enrollment

1,000 participants

Start Date

Nov 17, 2022

Study Type

OBSERVATIONAL

Conditions

Nasopharyngeal Carcinoma

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

Min Age: 21 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients with nasopharyngeal carcinoma (a type of head and neck cancer linked to the Epstein-Barr virus, or EBV) can have their treatments personalized based on EBV levels in their blood, potentially allowing some patients to receive less intensive treatment. **You may be eligible if...** - You are 21 years or older - You have been newly diagnosed with nasopharyngeal carcinoma (stages 2–4A) OR have metastatic/recurring nasopharyngeal cancer - Your cancer is linked to EBV infection (confirmed by lab tests) - You are able to give written consent and follow the study schedule **You may NOT be eligible if...** - Your cancer is not associated with EBV - You have been previously treated for nasopharyngeal cancer (in most cases) - Your overall health is too poor to tolerate cancer treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERArm 1

Concurrent chemoradiotherapy (CCRT) using cisplatin (100 mg/m2 IV) or carboplatin (AUC 5 IV) with radiotherapy +/- adjuvant chemotherapy (AC). For AC, physicians can choose between cisplatin-5FU d1-4, q4w for 3 cycles, or capecitabine 650 mg/m2 bid for 12 months or 1000 mg/m2 bid oral, d1-21, q3w for 6 months

OTHERArm 2

IC using cisplatin (80 mg/m2 IV) or carboplatin (AUC 3-5 IV) in combination with gemcitabine (1000 mg/m2 d1,8) or 5-fluorouracil (1000 mg/m2 bolus IV d1-4) or docetaxel (75 mg/m2 IV), and CCRT +/- metronomic capecitabine (650 mg/m2 bid oral for 12 months)

OTHERArm 3

IC using cisplatin (80 mg/m2 IV) or carboplatin (AUC 3-5 IV) in combination with gemcitabine (1000 mg/m2 d1,8) or 5-fluorouracil (1000 mg/m2 bolus IV d1-4) or docetaxel (75 mg/m2 IV), followed by either of the following: 1. RIBBON-LA-01 (NCT06093061) 2. CCRT + metronomic capecitabine (650 mg/m2 bid oral for 12 months)

OTHERGroup 1

Combination chemotherapy (using cisplatin or carboplatin with gemcitabine, 5-fluorouracil or docetaxel) and consolidative RT to the nasopharynx and neck (if good response to chemotherapy) +/- metastasis-directed therapy (surgery, radiofrequency ablation or RT) +/- immune checkpoint blockade (ICB) or capecitabine

OTHERGroup 2

Combination chemotherapy (using cisplatin or carboplatin with gemcitabine, 5-fluorouracil or docetaxel) with or without ICB +/- maintenance ICB or capecitabine

Locations(1)

National Cancer Centre Singapore

Singapore, Singapore

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NCT05517135

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