{"entity":{"id":"alliance-a021501","kind":"trial","name":"Alliance A021501","aka":["A021501"],"tldr":"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.","summary":"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.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02839343","url":"https://clinicaltrials.gov/study/NCT02839343"},{"label":"Katz et al., A021501 (JAMA Oncology 2022)","url":"https://doi.org/10.1001/jamaoncol.2022.2319"}],"tags":[],"related":[],"cancers":["pancreatic","borderline-resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","sbrt","hypofractionated-radiotherapy"],"targets":[],"drugs":["folfirinox","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":["resectability","resection-margins","neoadjuvant-adjuvant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02839343","phase":"2","setting":"Borderline resectable adenocarcinoma of the pancreatic head in the United States and Canada: eight cycles of modified FOLFIRINOX, against seven cycles followed by stereotactic (33 to 40 Gy in five fractions) or hypofractionated image-guided (25 Gy in five fractions) radiotherapy, then surgery and four cycles of FOLFOX, each arm compared with an 18-month survival of 50 percent from history","sponsor":"Alliance for Clinical Trials in Oncology / National Cancer Institute","result":"18-month overall survival 66.7 percent with neoadjuvant modified FOLFIRINOX alone against 47.3 percent with chemotherapy plus hypofractionated radiotherapy; the radiotherapy arm closed at interim analysis (R0 resection 10 of the first 30 against 17 of 30).","yearReported":2022,"enrolled":126,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 18 months (evaluable patients)","primary":true,"unit":"%","arms":[{"name":"Neoadjuvant mFOLFIRINOX x8","n":70,"value":66.7,"note":"95% CI 56.1 to 79.4; median 29.8 months"},{"name":"mFOLFIRINOX x7 then SBRT or hypofractionated radiotherapy","n":56,"value":47.3,"note":"95% CI 35.8 to 62.5; median 17.1 months; arm closed at interim analysis"}],"source":"https://doi.org/10.1001/jamaoncol.2022.2319"}]},"route":"/trials/alliance-a021501/","neighbours":{"cancer":[{"id":"borderline-resectable-pdac","kind":"cancer","name":"Borderline resectable pancreatic ductal adenocarcinoma","route":"/cancers/borderline-resectable-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"hypofractionated-radiotherapy","kind":"technology","name":"Hypofractionated radiotherapy","route":"/technologies/hypofractionated-radiotherapy/"},{"id":"sbrt","kind":"technology","name":"SBRT / SABR (stereotactic radiotherapy)","route":"/technologies/sbrt/"}],"drug":[{"id":"folfirinox","kind":"drug","name":"FOLFIRINOX / mFOLFIRINOX","route":"/drugs/folfirinox/"},{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"}],"term":[{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"},{"id":"pancreatic-failed-programmes","kind":"term","name":"Pancreatic cancer: the failed and stopped programmes and why","route":"/terms/pancreatic-failed-programmes/"},{"id":"resectability","kind":"term","name":"Resectable, borderline resectable and unresectable","route":"/terms/resectability/"},{"id":"resection-margins","kind":"term","name":"Resection margins (R0 / R1 / R2)","route":"/terms/resection-margins/"}],"trial":[{"id":"espac-5","kind":"trial","name":"ESPAC-5","route":"/trials/espac-5/"}]}}