The ADIUVO study is a prospective, randomized, open-label, controlled, international, phase III trial for patients with ACC after radical resection.
In a parallel group design, patients will be randomized 1:1 to receive adjuvant therapy with mitotane or observational follow-up only. The overall study duration is 4 years from initial recruitment. Key inclusion criteria are: histologically confirmed diagnosis of ACC according to Weiss system; patient age ≥18 years; low/intermediate risk of recurrence defined as ENS@T stage I-III ACC, no evidence of microscopically residual disease and Ki-67 (MIB1) labeling index ≤ 10%. Key exclusion criteria are: history of prior malignancy; previous or current treatment with mitotane or other antineoplastic drugs; time between primary surgery and randomization >3 months, and repeated surgery for ACC recurrence. In the treatment arm, mitotane will be administered orally and adjusted according to target plasma levels (> 14 μg/l) and tolerability. Mitotane will be administered until ACC recurrence, intolerable toxicity, and consent withdrawal or until a treatment period of 2 years has been reached.
In the control arm, patients will receive no adjuvant treatment but will be monitored closely for recurrence with the same procedures as for treated patients.
Visit the website for more information: https://www.epiclin.it/adiuvo