Evaluation of Side Effects of Mitotane

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00568139

Enrollment

400

Registered

2007-12-05

Start date

2008-01-01

Completion date

2029-12-01

Last updated

2026-05-07

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

Conditions

Adrenocortical Carcinoma

Keywords

adrenal cancer, mitotane (Lysodren), adverse events

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORMartin Fassnacht, MD

University of Wuerzburg

Outcome results