Efficacy of adjuvant mitotane treatment in prolonging recurrence-free survival in patients with adrenocortical carcinoma at low-intermediate risk for recurrence (ADIUVO-trial) - ADIUVO

niversity Hospital Azienda Ospedaliero S.Luigi Gonzaga Orbassano0 个研究点目标入组 200 人开始时间: 2010年10月13日最近更新: 2021年6月21日

适应症

试验速览

暂无简介。

•Histologically confirmed diagnosis of ACC
•Low-intermediate risk of relapse defined as:
•Stage I-III ACC (according to the ENS@T classification 2008)
•Microscopically complete resection, defined as no evidence of microscopic residual disease based on surgical reports, histopathology and post-operative imaging
•Ki 67 = 10%
•Post-operative imaging (thoracic and whole abdominal CT with contrast medium or MRI) demonstrating no evidence of disease within 4 weeks before randomization
•Age = 18 years
•ECOG performance status 0-2
•Adequate bone marrow reserve (neutrophils = 1000/mm3 and/or platelets= 80000/ mm3)
•Ability to comply with the protocol procedures
•Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Time between primary surgery and randomization >3 months.
•Repeated surgery for recurrence of disease
•Persistence of autonomous adrenocortical hormone secretion following surgery
•History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies where there has been no evidence of disease for at least three years
•Renal insufficiency (creatinine clearance < 40 ml/min) or liver insufficiency (serum bilirubin > 2 times the upper normal range and/or serum transaminases (AST, ALT) >3 times the upper normal range). Creatinine clearence may be calculated according to validated formulae (Crockoft’s or MDRD)
•Pregnancy or breast feeding
•Previous or current treatment with mitotane or other antineoplastic drugs for ACC
•Previous radiotherapy for ACC

发起方

niversity Hospital Azienda Ospedaliero S.Luigi Gonzaga Orbassano