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A021501 set out to test radiotherapy before surgery for borderline pancreatic cancer and closed that arm early because fewer patients reached a clear-margin operation; chemotherapy alone gave 18-month survival of 67 percent and a median of 29.8 months, and became the reference regimen for the setting.
A021501 registered 126 patients between February 2017 and January 2019: 70 to systemic therapy alone (54 randomised plus 16 after the radiotherapy arm closed) and 56 to chemotherapy followed by hypofractionated radiotherapy. A planned interim analysis mandated closure of any arm in which 11 or fewer of the first 30 patients had an R0 resection: 17 of 30 (57 percent) in the chemotherapy arm and 10 of 30 (33 percent) in the radiotherapy arm, so arm 2 closed. Among evaluable patients the 18-month overall survival rate was 66.7 percent (95 percent confidence interval 56.1 to 79.4) with chemotherapy alone and 47.3 percent (35.8 to 62.5) with chemotherapy and radiotherapy, and median overall survival 29.8 against 17.1 months. The authors concluded that neoadjuvant modified FOLFIRINOX alone is the reference for borderline resectable disease; the trial is the reason NCCN and the corpus's borderline row describe radiotherapy as optional rather than routine.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
126 enrolled.
95% CI 56.1 to 79.4; median 29.8 months · 95% CI 35.8 to 62.5; median 17.1 months; arm closed at interim analysis
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival at 18 months (evaluable patients)primary | Neoadjuvant mFOLFIRINOX x8 | 70 | 66.7% | - | - | link |
| mFOLFIRINOX x7 then SBRT or hypofractionated radiotherapy | 56 | 47.3% |
Shares ESPAC-5, Hypofractionated radiotherapy, Pancreatic cancer: the failed and stopped programmes and why, FOLFIRINOX / mFOLFIRINOX.
Shares Resectable, borderline resectable and unresectable, Resection margins (R0 / R1 / R2), Pancreatic cancer: the failed and stopped programmes and why, FOLFIRINOX / mFOLFIRINOX.
Shares ESPAC-5, FOLFIRINOX / mFOLFIRINOX, Borderline resectable pancreatic ductal adenocarcinoma, Pancreatic ductal adenocarcinoma.
Shares ESPAC-5, Resectable, borderline resectable and unresectable, Resection margins (R0 / R1 / R2), FOLFIRINOX / mFOLFIRINOX.
Shares Resectable, borderline resectable and unresectable, FOLFIRINOX / mFOLFIRINOX, Neoadjuvant / adjuvant / perioperative, Cytotoxic chemotherapy.
Shares Resectable, borderline resectable and unresectable, Borderline resectable pancreatic ductal adenocarcinoma, Neoadjuvant / adjuvant / perioperative, Pancreatic ductal adenocarcinoma.
Shares Resectable, borderline resectable and unresectable, Resection margins (R0 / R1 / R2), Borderline resectable pancreatic ductal adenocarcinoma, Neoadjuvant / adjuvant / perioperative.
Shares Resectable, borderline resectable and unresectable, FOLFIRINOX / mFOLFIRINOX, Neoadjuvant / adjuvant / perioperative, Cytotoxic chemotherapy.