Efficacy of adjuvant mitotane treatment in prolonging recurrence -free survival in -patients with adrenocortical carcinoma at low-intermediate risk of recurrence

Phase 3

Completed

Conditions: adrenocortical carcinoma
carcinoma of the adrenal cortex
10001353

Registration Number: NL-OMON36658

Lead Sponsor: Azienda Ospedaliera S. Luigi Gonzaga

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

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.
Ki67 index < or equal 10 %.
Post-operative imaging demonstrating no evidence of disease within 4 weeks before randomization.
ECOG performance status 0-2.
Age equal to or older then 18 years
Adequate bone marrow reserve (neutrophils equal or higher then 1.0 * 10^9/L and/or platelets equal or higher then 80.0 * 10^9/L)
Ability to comply with the protocol procedures
Written informed consent

Exclusion Criteria

Time between primary surgery and randomization > 3 months.
Repeated surgery for recurrence of disease.
Renal insufficiency (creatinine clearance <40 ml/min) or liver insufficiency (serum bilirubin >2 times the upper normal range and/ or serum transamininase (AST,ALT)> 3 times the upper normal range).
History of recent or active prior malignancy, except for cured non melanoma skin cancer, cured insitu cervical carinoma, or other treated malignancies where there has been no evidence of disease for at least tree years.
Previous or current treatment with mitotane or other antineoplastic drugs for ACC.
Previous radiotherapy for ACC.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Recurence free survival, defined as the time between the date of randomization<br /><br>until documentation of any of the following failures (whichever occurs first):<br /><br>- local or distant recurrence of ACC<br /><br>- death from any cause or completion of follow-up</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Overall survival, defined as the time between the date of randomization and<br /><br>the date of of death from any cause<br /><br>- Time to recurrence, defined as the time between the date of randomization<br /><br>until documentation of local or distant recurrence of ACC, or death from ACC<br /><br>- disease free survival, defined as the time between the date of randomization<br /><br>until documentation of any relevant cancer disease, or death of any cause<br /><br>(whichever occurs first)<br /><br>- Quality of life measured by EORTC-QLQ-C30</p><br>