MedPath

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

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
NameTimeMethod
Documentation of adverse effectsfrom 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University Hospital

🇩🇪

Wuerzburg, Germany

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