{"entity":{"id":"petacc-3","kind":"trial","name":"PETACC-3","aka":[],"tldr":"Irinotecan works in advanced bowel cancer and does nothing after surgery. The trial's tumour bank turned out to be worth more than its result.","summary":"PETACC-3 tested whether irinotecan added to biweekly infusional fluorouracil and leucovorin improves adjuvant treatment of colon cancer. In the principal analysis of 2,094 treated stage III patients, five-year disease-free survival was 56.7 percent with irinotecan against 54.3 percent without (log-rank p=0.106) and five-year overall survival 73.6 against 71.3 percent (p=0.094); irinotecan increased grade 3 to 4 gastrointestinal events and neutropenia. With CALGB 89803 reaching the same conclusion, irinotecan was abandoned in the adjuvant setting, and the pattern, that a drug active in metastatic disease can add nothing to surgery, repeated itself later with cetuximab and with bevacizumab. The trial's large annotated tumour bank became one of the main sources for the prognostic work on microsatellite instability, BRAF and the gene-expression subtypes that became the consensus molecular subtypes.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00026273","url":"https://clinicaltrials.gov/study/NCT00026273"},{"label":"PETACC-3: irinotecan added to adjuvant fluorouracil and leucovorin in stage III colon cancer (Journal of Clinical Oncology 2009)","url":"https://doi.org/10.1200/JCO.2008.21.6663"}],"tags":[],"related":[],"cancers":["colorectal","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["irinotecan","fluorouracil","leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","cms-subtypes","msi"],"trials":["n0147","mosaic"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00026273","phase":"3","setting":"Stage II and III colon cancer after resection: biweekly infusional fluorouracil and leucovorin with or without irinotecan","sponsor":"Pan-European Trials in Alimentary Tract Cancer / Pfizer","result":"Five-year disease-free survival 56.7 against 54.3 percent (p=0.106); no overall survival gain.","yearReported":2009,"enrolled":2094,"enrolledBasis":"analysed","enrolledNote":"3,278 patients were enrolled; the principal efficacy analysis was of the 2,094 treated patients with stage III disease randomised in the LV5FU2 strata.","outcomes":[{"endpoint":"Disease-free survival at 5 years (stage III)","primary":true,"unit":"percent","arms":[{"name":"Irinotecan with LV5FU2","value":56.7},{"name":"LV5FU2","value":54.3}],"p":"0.106","source":"https://doi.org/10.1200/JCO.2008.21.6663"}],"replication":"CALGB 89803 also found no benefit from adjuvant irinotecan."},"route":"/trials/petacc-3/","neighbours":{"cancer":[{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-cancer/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"drug":[{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"irinotecan","kind":"drug","name":"Irinotecan (and liposomal irinotecan)","route":"/drugs/irinotecan/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"}],"term":[{"id":"cms-subtypes","kind":"term","name":"Consensus molecular subtypes (CMS1-4)","route":"/terms/cms-subtypes/"},{"id":"msi","kind":"term","name":"Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)","route":"/terms/msi/"},{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"}],"trial":[{"id":"n0147","kind":"trial","name":"Alliance N0147","route":"/trials/n0147/"},{"id":"mosaic","kind":"trial","name":"MOSAIC","route":"/trials/mosaic/"}]}}