Evaluation of Side Effects of Mitotane

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Adrenocortical Carcinoma Adenocarcinoma Adrenal Cortex Diseases Adrenal Cortex Neoplasms Adrenal Gland Diseases Adrenal Gland Neoplasms Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Würzburg, 97080, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

Documentation of adverse effects

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Wuerzburg

Other

Registry information

Official study title

Evaluierung Von Nebenwirkungen Einer Therapie Mit Mitotane Beim Nebennierenkarzinom- Evaluation of Side Effects of Mitotane in Adrenocortical Carcinoma

Important dates

Study start: 2008
Primary completion: 2027
Study completion: 2029
First posted: Dec 5, 2007
Registry last updated: May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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