Trial reportBMC oral health2026
Efficacy and safety of schedule-modified oral capecitabine/S-1 as maintenance therapy for stage N3 nasopharyngeal carcinoma after definitive chemoradiotherapy: a multicentre, single-arm phase II clinical trial.
Trial report in BMC oral health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04220528 (Single Arm, Open, Multicenter Phase II Clinical Study of Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Single Arm, Open, Multicenter Phase II Clinical Study of Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC
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Authors and funding
10 authors.
Funding
Abstract
background and purposeN3 nasopharyngeal carcinoma (NPC) continues to demonstrate high distant metastasis rates despite aggressive treatment. This phase II trial evaluated schedule-modified oral maintenance chemotherapy with capecitabine or S-1 following definitive chemoradiotherapy in this high-risk population.
methodsIn this multicenter, single-arm study, patients with non-metastatic N3 NPC received induction chemotherapy (gemcitabine/nedaplatin) followed by concurrent definitive chemoradiotherapy (nedaplatin). Within one month post-radiotherapy, patients initiated 12 cycles of oral maintenance therapy (capecitabine 1250 mg/m² twice daily or S-1 body surface area based dosing, days 1-14, every 28 days). Primary endpoint was 2-year progression-free survival (PFS).
resultsAmong 115 enrolled patients, after 46.2 months median follow-up, 2-year PFS reached 92.0% (95% CI: 87.1-97.2). The 2-year overall survival, locoregional recurrence-free survival, and distant metastasis-free survival rates were 98.3%, 98.1%, and 92.9%, respectively. Maintenance therapy demonstrated favorable tolerability with only 7.0% grade 3 adverse events and no grade 4/5 events. Notably, 78.3% of patients completed all 12 maintenance cycles.
conclusionSchedule-modified oral maintenance chemotherapy with capecitabine or S-1 following definitive chemoradiotherapy showed promising efficacy and manageable toxicity in stage N3 NPC, supporting further investigation of this consolidation approach.
trial registrationClinicalTrials.gov, Registration number: NCT04220528, Date of registration: January 4, 2020, Retrospectively registered.
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