{"entity":{"id":"adiuvo","kind":"trial","name":"ADIUVO","aka":["ADIUVO trial"],"tldr":"ADIUVO asked whether people whose low-grade adrenal cancer had been fully removed should take the toxic drug mitotane for two years to prevent recurrence; recurrence and survival were no different from watching and waiting, so observation with regular scans is the standard for this group.","summary":"ADIUVO was an international open-label randomised phase 3 trial with a parallel observational study, run by the University of Turin with the ENSAT network, in patients with completely resected adrenocortical carcinoma at low to intermediate risk of recurrence. Patients were randomised to adjuvant mitotane for at least two years or active surveillance; the primary endpoint was recurrence-free survival. Slow recruitment closed the trial after 91 randomised patients.\n\nFive-year recurrence-free survival was 79 percent with mitotane against 75 percent with surveillance (hazard ratio 0.74, not significant) and five-year overall survival 95 against 86 percent with two and five deaths respectively; every patient on mitotane had adverse events and 19 percent stopped treatment. The corpus's localised adrenocortical carcinoma page cites ADIUVO for observation rather than mitotane in low-risk disease, and ADIUVO-2 now tests intensified adjuvant treatment in high-risk disease.","status":"negative","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00777244","url":"https://clinicaltrials.gov/study/NCT00777244"}],"tags":["soc-trials"],"related":[],"cancers":["localised-adrenocortical-carcinoma","adrenocortical"],"sections":[],"technologies":[],"targets":[],"drugs":["mitotane"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-adiuvo-adjuvant-mitotane-low-grade-acc-terzolo-lancet-diabetes-endocrinol-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00777244","phase":"3","setting":"Completely resected adrenocortical carcinoma at low to intermediate risk of recurrence (stage I to III, R0, Ki67 10 percent or less) at 23 centres in seven countries: adjuvant mitotane for at least two years against surveillance, with recurrence-free survival as the primary endpoint","sponsor":"University of Turin, Italy","result":"Five-year recurrence-free survival 79 percent with adjuvant mitotane against 75 percent with surveillance (hazard ratio 0.74, 95% CI 0.30 to 1.85); overall survival not significantly different; adverse events in every mitotane patient.","yearReported":2023,"enrolled":91,"enrolledBasis":"randomised","enrolledNote":"The registry gives an estimated 200 and was never updated; the Lancet Diabetes and Endocrinology report randomised 91 patients (45 mitotane, 46 surveillance) between 2008 and 2018 before the trial closed for slow recruitment, alongside an observational cohort of 95.","outcomes":[{"endpoint":"Recurrence-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Adjuvant mitotane","n":45,"value":79,"note":"95% CI 67 to 94"},{"name":"Surveillance","n":46,"value":75,"note":"95% CI 63 to 90"}],"hr":0.74,"ci":[0.3,1.85],"source":"https://doi.org/10.1016/S2213-8587(23)00193-6"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Adjuvant mitotane","n":45,"value":95,"note":"95% CI 89 to 100; 2 deaths"},{"name":"Surveillance","n":46,"value":86,"note":"95% CI 74 to 100; 5 deaths"}],"source":"https://doi.org/10.1016/S2213-8587(23)00193-6"},{"endpoint":"Discontinuation of mitotane for adverse events","unit":"%","arms":[{"name":"Adjuvant mitotane","n":42,"value":19,"note":"All 42 treated patients had adverse events; no grade 4 events"}],"source":"https://doi.org/10.1016/S2213-8587(23)00193-6"}]},"route":"/trials/adiuvo/","neighbours":{"cancer":[{"id":"adrenocortical","kind":"cancer","name":"Adrenocortical carcinoma","route":"/cancers/adrenocortical/"},{"id":"localised-adrenocortical-carcinoma","kind":"cancer","name":"Localised adrenocortical carcinoma (ENSAT stage I to III, resectable)","route":"/cancers/localised-adrenocortical-carcinoma/"}],"drug":[{"id":"mitotane","kind":"drug","name":"Mitotane","route":"/drugs/mitotane/"}],"paper":[{"id":"paper-adiuvo-adjuvant-mitotane-low-grade-acc-terzolo-lancet-diabetes-endocrinol-2023","kind":"paper","name":"ADIUVO: adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma","route":"/key-papers/paper-adiuvo-adjuvant-mitotane-low-grade-acc-terzolo-lancet-diabetes-endocrinol-2023/"}]}}