INT-0099

Regimen

Experimental
Concurrent cisplatin 100 mg/m² q3w ×3 + RT 70 Gy, followed by adjuvant cisplatin 80 mg/m² + 5-FU 1000 mg/m²/d ×4d q4w ×3
Control
Radiotherapy alone 70 Gy

Population

Stage III-IV (non-metastatic) NPC, North American centres (WHO any histology)

Key finding

First phase 3 demonstration that adding concurrent cisplatin plus adjuvant PF to RT roughly doubles PFS and OS in locally advanced NPC. Trial stopped early at interim for efficacy. Recalibrated NCCN NPC standard-of-care from RT-alone to CCRT worldwide. The predominantly keratinizing North American population limited direct extrapolation to endemic Asian non-keratinizing NPC, motivating the subsequent Hong Kong and Singaporean confirmation trials.

Source: PMID 9552031

Timeline

    Guideline citations

    • NCCN NPC (p.42)