{"entity":{"id":"neonax","kind":"trial","name":"NEONAX","aka":["AIO-PAK-0313"],"tldr":"NEONAX compared giving gemcitabine and nab-paclitaxel around surgery with giving it only afterwards; neither arm reached the trial's 55 percent target for being relapse-free at 18 months, but patients treated before surgery lived a median 25.5 months against 16.7, mostly because so few in the surgery-first arm were ever fit enough to start chemotherapy.","summary":"NEONAX randomised 127 patients 1 to 1 to perioperative (arm A) or adjuvant-only (arm B) gemcitabine 1,000 mg/m2 with nab-paclitaxel 125 mg/m2 on days 1, 8 and 15 of 28-day cycles. The pre-defined 18-month disease-free survival rate of 55 percent was reached in neither arm (A 33.3 percent, 95 percent confidence interval 18.5 to 48.1; B 41.4 percent, 20.7 to 62.0, in the modified intention-to-treat population of resected patients who started their allocated chemotherapy). Ninety percent of arm A completed neoadjuvant treatment while only 42 percent of arm B started adjuvant chemotherapy; R0 resection was 88 against 67 percent. In the full intention-to-treat population median overall survival was 25.5 months (19.7 to 29.7) in the perioperative arm against 16.7 months (11.6 to 22.2) with upfront surgery, and median disease-free survival 11.5 against 5.9 months. The authors called neoadjuvant treatment a novel option whose regimen remains to be defined; the corpus cites the trial beside NORPACT-1 and SWOG S1505 as the phase 2 evidence that frames Alliance A021806 and PREOPANC-3.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02047513","url":"https://clinicaltrials.gov/study/NCT02047513"},{"label":"Seufferlein et al., NEONAX (Annals of Oncology 2023)","url":"https://doi.org/10.1016/j.annonc.2022.09.161"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel"],"companies":["aio"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02047513","phase":"2","setting":"Resectable pancreatic ductal adenocarcinoma at 22 German centres: two cycles of gemcitabine plus nab-paclitaxel before surgery and four after, against six adjuvant cycles after upfront surgery, with 18-month disease-free survival as the primary endpoint in each arm","sponsor":"AIO-Studien-gGmbH (German pancreatic cancer group), with Celgene","result":"18-month disease-free survival 33.3 percent (perioperative) and 41.4 percent (adjuvant), both below the 55 percent target; median overall survival 25.5 against 16.7 months in the intention-to-treat population.","yearReported":2023,"enrolled":127,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 18 months (modified intention to treat)","primary":true,"unit":"%","arms":[{"name":"Perioperative gemcitabine + nab-paclitaxel","value":33.3,"note":"95% CI 18.5 to 48.1"},{"name":"Adjuvant gemcitabine + nab-paclitaxel after upfront surgery","value":41.4,"note":"95% CI 20.7 to 62.0"}],"source":"https://doi.org/10.1016/j.annonc.2022.09.161"},{"endpoint":"Overall survival (intention to treat)","unit":"months","arms":[{"name":"Perioperative gemcitabine + nab-paclitaxel","value":25.5,"note":"95% CI 19.7 to 29.7"},{"name":"Adjuvant gemcitabine + nab-paclitaxel after upfront surgery","value":16.7,"note":"95% CI 11.6 to 22.2"}],"source":"https://doi.org/10.1016/j.annonc.2022.09.161"}]},"route":"/trials/neonax/","neighbours":{"cancer":[{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"resectable-pdac","kind":"cancer","name":"Resectable pancreatic ductal adenocarcinoma","route":"/cancers/resectable-pdac/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"gemcitabine-nab-paclitaxel","kind":"drug","name":"Gemcitabine + nab-paclitaxel","route":"/drugs/gemcitabine-nab-paclitaxel/"},{"id":"nab-paclitaxel","kind":"drug","name":"Nab-paclitaxel","route":"/drugs/nab-paclitaxel/"}],"company":[{"id":"aio","kind":"company","name":"AIO (Arbeitsgemeinschaft Internistische Onkologie)","route":"/companies/aio/"}],"term":[{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"}],"trial":[{"id":"norpact-1","kind":"trial","name":"NORPACT-1","route":"/trials/norpact-1/"}]}}