ALLIANCE-A021501

NCT02839343 📎

Regimen

Experimental
Arm A: 8 cycles neoadjuvant mFOLFIRINOX then surgery + 4 cycles adjuvant FOLFOX. Arm B: 7 cycles mFFX + SBRT 33-40 Gy/5 fx or HIGRT 25 Gy/5 fx then surgery + 4 cycles FOLFOX.
Control
Arm A (chemo-only neoadjuvant) vs Arm B (chemo + SBRT neoadjuvant); both compared against prespecified 18-month OS benchmark (50%).

Population

Borderline resectable PDAC (central radiographic review), ECOG 0-1, US Alliance cooperative group multicenter.

Key finding

A021501 showed neoadjuvant mFFX alone is feasible and meets the efficacy threshold in borderline resectable PDAC (18-mo OS 67.9%), whereas adding hypofractionated RT/SBRT does NOT improve outcomes and may be detrimental (47.3%). Arm B was halted early for futility.

Source: PMID 35834226

Timeline

    Guideline citations

    • NCCN PANCREATIC (p.71)