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Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

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Nasopharyngeal Neoplasms

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Gemcitabine

Capecitabine

Carboplatin

Docetaxel

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Cisplatin

Arm 1: EBV DNA \<4000 copies/mL AND T3N0-2 or T4N0 (TNM AJCC/UICC 8th edition)

Arm 2: EBV DNA ≥4000 copies/mL OR N3 OR T4N+ (TNM AJCC/UICC 8th edition) AND EBV DNA undetectable after 2-3 cycles of induction chemotherapy (IC)

Arm 3: EBV DNA ≥4000 copies/mL OR N3 OR T4N+ (TNM AJCC/UICC 8th edition) AND EBV DNA detectable after 2-3 cycles of IC

Group 1: Recurrent/metastatic NPC, EBV DNA \<4000 copies/mL

Group 2: Recurrent/metastatic NPC, EBV DNA ≥4000 copies/mL

Concurrent chemoradiotherapy (CCRT) using cisplatin (100 mg/m2 IV) or carboplatin (AUC 5 IV) with radiotherapy +/- adjuvant chemotherapy (AC) with capecitabine (physician's choice of 650 mg/m2 bid or 1000 mg/m2 bid oral, d1-21, q3w)

Arm 1

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

Arm 2

CCRT + metronomic capecitabine (650 mg/m2 bid oral, d1-21, q3w)

Arm 3

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

Group 1

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

Group 2

Melvin Lee Kiang Chua, MBBS, FRCR, PhD, FAMS

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.

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. Primary study end-point is 2-year disease-free survival (DFS).

Archival tissue, fresh tumour biopsy tissue, saliva and peripheral blood samples will be obtained for this study

Treatment Individualisation by EBV Stratification in Nasopharyngeal Carcinoma: a Prospective Observational Study

Blood samples will be collected at up to 7 timepoints - baseline, mid/post IC, mid CCRT, 1-2 weeks post-RT, 3 months post-RT/mid-adjuvant chemotherapy, at point of recurrence and post immune checkpoint blockade treatment (for recurrence, if any); fresh biopsy samples will be collected at baseline and at point of recurrence, if amenable for biopsy. Saliva samples will be collected at baseline and at point of recurrence.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Treatment Individualisation by EBV Stratification in Nasopharyngeal Carcinoma: a Prospective Observational Study	NCT05517135	Nasopharyngeal ...	Arm 1 Arm 2 Arm 3 Group 1 Group 2	21 Years - 99 Years	National Cancer Centre, Singapore
Treatment Individualisation by EBV Stratification in Nasopharyngeal Carcinoma: a Prospective Observational Study	NCT05517135	Nasopharyngeal ...	Arm 1 Arm 2 Arm 3 Group 1 Group 2	21 Years - 99 Years	National Cancer Centre, Singapore

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