CHEN-L-2012

NCT00677118 📎

Regimen

Experimental
CCRT (cisplatin q3w ×3 + RT) followed by adjuvant cisplatin + 5-FU ×3 cycles (INT-0099 adjuvant component)
Control
CCRT alone (cisplatin q3w ×3 + RT), no adjuvant

Population

Locoregionally advanced NPC, post-CCRT, stage III-IVB M0, multicentre China (SYSU-led)

Key finding

Tested whether adding the adjuvant PF component from INT-0099 to CCRT (the component often dropped in practice) provided additional benefit over CCRT alone. The answer was no — adjuvant PF did not significantly improve failure-free survival after CCRT. This was the first large Chinese RCT to formally de-escalate adjuvant chemotherapy in NPC, challenging the INT-0099 triphasic paradigm and supporting CCRT-only as an adequate locoregional treatment. The negative result catalysed the field's pivot toward alternative adjuvant strategies (metronomic, maintenance, EBV-guided).

Source: PMID 22154591

Timeline

    Guideline citations

    • NCCN NPC (p.42)