Adrenocortical Carcinoma Clinical Trial
Official title:
Efficacy of Adjuvant Mitotane Treatment in Prolonging Recurrence-free Survival in Patients With Adrenocortical Carcinoma at Low-intermediate Risk of Recurrence
Study Rationale Adrenocortical carcinoma (ACC) is a very rare disease with a high risk of
relapse after radical surgery. The efficacy of adjuvant mitotane treatment is suggested by a
retrospective multicenter international study showing that postoperative mitotane treatment
was associated with a significant reduction of the risk of relapse and death. However, these
promising results need confirmation in a randomized prospective study. Caution should be
adopted particularly in patients with low risk of disease relapse, in whom the benefit of
therapy should be weighted against the side effects. Even if an adjuvant treatment seems
justified in patients at high risk of relapse, a randomised prospective study is needed to
assess whether such a treatment is efficacious in patients at low-intermediate risk.
The purpose of the present study is to determine whether adjuvant mitotane treatment is
effective in prolonging the disease free survival in patients with adrenocortical carcinoma
at low-intermediate risk of progression who underwent radical resection
Endpoints Primary : To compare DFS (Disease Free Survival), defined as the time between the
date of randomization until documentation of any of the following failures (whichever occurs
first): -local or distant recurrence of disease;-death from any cause or completion of
follow-up.
Secondary:
To compare OS (Overall Survival), defined as the time interval between the date of
randomization and the date of death from any cause or the last known alive date;· To compare
quality of life measured by EORTC-QLQ-C30· To compare toxicity, graded according to the
NCI-CTG criteria;· To compare DFS and OS in patients who achieve or not serum mitotane
concentrations > 14 mg/L;· To compare DFS and OS between the 2 arms in patients subgroups
stratified according to: type of hormone secretion, stage of disease, histopathologic
characteristics.
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