NCT05517135

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: —

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).

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
OTHER	Arm 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
OTHER	Arm 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)
OTHER	Arm 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)
OTHER	Group 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
OTHER	Group 2	Combination chemotherapy (using cisplatin or carboplatin with gemcitabine, 5-fluorouracil or docetaxel) with or without ICB +/- maintenance ICB or capecitabine

Timeline

• Start date: 2022-11-17
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2022-08-26
• Last updated: 2024-09-19

Locations

1 site across 1 country: Singapore