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NCT00568139 Clinical Trial

Evaluation of Side Effects of Mitotane

Adrenocortical Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00568139
Other study ID # Wue-ACC-Mitotane
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 2008
Est. completion date December 2024

Study information
Verified date April 2024
Source University of Wuerzburg
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 400
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Adrenocortical carcinoma - Treatment with mitotane monotherapy as first-line therapy (in adjuvant setting or advanced disease)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University Hospital Wuerzburg

Sponsors (1)
Lead Sponsor Collaborator
University of Wuerzburg

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Documentation of adverse effects Adverse effects will be documented using the NCI CTC AE v5.5 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
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