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

Phase 1

• Conditions: Adrenocortical carcinoma; MedDRA version: 12.1Level: LLTClassification code 10001388Term: Adrenocortical carcinoma; MedDRA version: 12.1Level: PTClassification code 10001388Term: Adrenocortical carcinoma

• Registration Number: EUCTR2007-007262-38-DE
• Lead Sponsor: niversity Hospital Azienda Ospedaliero S.Luigi Gonzaga Orbassano

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-13
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of adjuvant mitotane treatment vs observation only in prolonging recurrence free survival in patients with ACC at low-intermediate risk of recurrence after complete resection.;Secondary Objective: - Comparison of Overall Survival (OS) <br>- Comparison of time to recurrence (TTR) <br>- Comparison of disease free survival (DFS) <br>- Comparison of quality of life <br>- Assessment of toxicity <br>- Assessment of the impact of mitotane plasma levels and time needed to reach the therapeutic interval on the efficacy of treatment <br>- Assessment of the efficacy of the mitotane administration on subgroups of patients stratified according to: type of hormone secretion, stage of disease, histopathologic characteristics.;Primary end point(s): RFS, 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 ACC or death from any cause<br>