ESPAC-1

Regimen

Experimental
Chemotherapy arm: bolus 5-FU 425 mg/m2 + leucovorin 20 mg/m2 x 5d q4w x 6 cycles; chemoradiation arm: 40 Gy split-course + 5-FU.
Control
Observation alone, or opposite factorial arm.

Population

Resected PDAC, European multicenter, early enrollment (1994-2000), 2x2 factorial design for chemoradiation (yes/no) and chemotherapy (yes/no).

Key finding

ESPAC-1 established for the first time that adjuvant systemic chemotherapy improves OS after PDAC resection, while adjuvant chemoradiation may actually harm survival. This divergence from the contemporaneous US GITSG doctrine reshaped European practice away from adjuvant chemoRT.

Source: PMID 15350935

Timeline

    Guideline citations

    • NCCN PANCREATIC (p.103)