# ADIUVO

Source: https://onco.cc/trials/adiuvo/  
OnCo record `adiuvo` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

Five-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.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-22
- Also known as: ADIUVO trial
- Tags: soc-trials
- Registry id: 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
- Enrolled: 91
- 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.
- Outcomes: Recurrence-free survival at 5 years: Adjuvant mitotane 79% vs Surveillance 75%, HR 0.74; Overall survival at 5 years: Adjuvant mitotane 95% vs Surveillance 86%; Discontinuation of mitotane for adverse events: Adjuvant mitotane 19%

## Sources

- ClinicalTrials.gov NCT00777244: https://clinicaltrials.gov/study/NCT00777244

## Connected records

- cancers: [Adrenocortical carcinoma](https://onco.cc/cancers/adrenocortical/), [Localised adrenocortical carcinoma (ENSAT stage I to III, resectable)](https://onco.cc/cancers/localised-adrenocortical-carcinoma/)
- drugs: [Mitotane](https://onco.cc/drugs/mitotane/)
- key papers: [ADIUVO: adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma](https://onco.cc/key-papers/paper-adiuvo-adjuvant-mitotane-low-grade-acc-terzolo-lancet-diabetes-endocrinol-2023/)

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