CONKO-001

NCT00513383 📎

Regimen

Experimental
Gemcitabine 1000 mg/m2 d1, 8, 15 q4w x 6 cycles (6 months).
Control
Observation alone.

Population

Resected PDAC (R0 or R1), German/Austrian multicenter, enrolled 1998-2004, long-term follow-up to 2012.

Key finding

CONKO-001 was the first trial to demonstrate a clear DFS and OS benefit for adjuvant gemcitabine monotherapy vs observation after PDAC resection. Established adjuvant chemotherapy (specifically gemcitabine) as the new global standard; served as the control arm for every subsequent adjuvant trial for the next decade.

Source: PMID 24104372

Timeline

    Guideline citations

    • NCCN PANCREATIC (p.54)