Evaluation of Side Effects of Mitotane

Active, not recruiting

• Conditions: Adrenocortical Carcinoma

• Registration Number: NCT00568139
• Lead Sponsor: University of Wuerzburg

Brief Summary

Mitotane is standard therapy in the treatment of adrenocortical carcinoma. However, many adverse effects are not well documented. Therefore, we are aiming at collecting data about adverse effects in patients treated with mitotane

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-05
• Study Start: 2008-01-01
• Status Verified: 2024-09
• Last Update Submitted: 2025-08-24
• Last Update Posted: 2025-08-26
• Primary Completion: 2025-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Adrenocortical carcinoma
• Treatment with mitotane monotherapy as first-line therapy (in adjuvant setting or advanced disease)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Documentation of adverse effects	from starting mitotane until discontinuation of mitotane (since this is very variable from patient to patient no specific number of days or weeks can be entered (standard therapy would be about 2 years) or start of additional other medical therapies	Adverse effects will be documented using the NCI CTC AE v5.5

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Würzburg, Germany