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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007262-38-IT

Enrollment

200

Registered

2008-03-20

Start date

2008-03-12

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PATIENTS WITH ADRENOCORTICAL CARCINOMA SUBMITTED TO RARICAL SURGERY MedDRA version: 9.1 Level: LLT Classification code 10001388 Term: Adrenocortical carcinoma

Interventions

Trade Name: LYSODREN Pharmaceutical Form: Tablet INN or Proposed INN: Mitotane Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500-

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - hystory of prior malignancy - high risck of recurrence

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Germany, Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026