# Alliance A021501: preoperative modified FOLFIRINOX with or without hypofractionated radiotherapy for borderline resectable pancreatic cancer

Source: https://onco.cc/key-papers/paper-alliance-a021501-mfolfirinox-radiotherapy-borderline-resectable-jama-oncol-2022/  
OnCo record `paper-alliance-a021501-mfolfirinox-radiotherapy-borderline-resectable-jama-oncol-2022` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In the first randomised US trial of neoadjuvant treatment for borderline resectable pancreatic cancer, eight cycles of modified FOLFIRINOX alone gave two-thirds of patients an 18-month survival, while replacing the last cycle with short-course radiotherapy did worse and that arm was stopped early.

## Summary

Multicentre randomised phase 2 trial in 126 patients with borderline resectable pancreatic ductal adenocarcinoma, assigned to eight cycles of modified FOLFIRINOX or to seven cycles followed by stereotactic body radiotherapy or hypofractionated image-guided radiotherapy, then surgery and adjuvant FOLFOX. The radiotherapy arm was closed at a planned interim analysis for futility.

Eighteen-month overall survival was 66.7 percent with chemotherapy alone and 47.3 percent with chemotherapy and radiotherapy; median overall survival was 29.8 against 17.1 months. The chemotherapy-alone arm met its prespecified benchmark against historical controls.

## Fields

- Kind: Key paper
- Last checked: 2026-09-21
- Journal: JAMA Oncology
- Year: 2022
- DOI: 10.1001/jamaoncol.2022.2319
- Authors: Katz MHG, Shi Q, Meyers J, et al.
- Findings: Eighteen-month overall survival 66.7 percent with modified FOLFIRINOX alone versus 47.3 percent with added radiotherapy.; Median overall survival 29.8 versus 17.1 months; the radiotherapy arm was closed early for futility.
- What it means: Neoadjuvant modified FOLFIRINOX without routine radiotherapy became the reference approach for borderline resectable disease in North America; radiotherapy is reserved for selected patients or trials.
- Caveats: The two arms were not formally compared with each other; each was judged against a historical benchmark.; Only about half of patients in each arm went on to resection, and the radiotherapy arm was small after early closure.

## Sources

- JAMA Oncol 2022: https://doi.org/10.1001/jamaoncol.2022.2319
- PubMed: https://pubmed.ncbi.nlm.nih.gov/35834226/

## Connected records

- cancers: [Borderline resectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/borderline-resectable-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- drugs: [FOLFIRINOX / mFOLFIRINOX](https://onco.cc/drugs/folfirinox/)
- journals: [JAMA Oncology](https://onco.cc/journals/jama-oncology/)

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