Efficacy of adjuvant mitotane treatment in prolonging disease-free survival in patients with adrenocortical cacinoma submitted to radical resection - ADIUVO

• Conditions: PATIENTS WITH ADRENOCORTICAL CARCINOMA SUBMITTED TO RARICAL SURGERY; MedDRA version: 9.1Level: LLTClassification code 10001388Term: Adrenocortical carcinoma

• Registration Number: EUCTR2007-007262-38-IT
• Lead Sponsor: AZIENDA OSPEDALIERA S. LUIGI GONZAGA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- ISTOLOGICALLY CONFIRMED DIAGNOSIS OF ADRENO-CORTICAL CARCINOMA - MACROSCOPICALLY COLPLETE RESECTION
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

- hystory of prior malignancy - high risck of recurrence

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Comapare the efficacy of adjuvant mitotane treatment versus no therapy in prolonging disease-free survival in patients with adrenocortical cacinoma submitted to radical resection;Secondary Objective: Camparison of overall survival;Primary end point(s): - Compare disease-free survival in the two arms - local or distant recurrence - death