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Evaluation of Side Effects of Mitotane

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00568139
Recruitment Status : Recruiting
First Posted : December 5, 2007
Last Update Posted : July 13, 2021
Information provided by (Responsible Party):
Martin Fassnacht, University of Wuerzburg

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

Condition or disease
Adrenocortical Carcinoma

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluierung Von Nebenwirkungen Einer Therapie Mit Mitotane Beim Nebennierenkarzinom- Evaluation of Side Effects of Mitotane in Adrenocortical Carcinoma
Actual Study Start Date : January 2008
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Mitotane

Patients with adrenocortical carcinoma treated with mitotane
Patients with adrenocortical carcinoma not treated with mitotane

Primary Outcome Measures :
  1. Documentation of adverse effects [ Time Frame: from starting mitotane treatment 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) ]
    Adverse effects will be documented using the NCI CTC AE v5

Biospecimen Retention:   Samples Without DNA
Serum, plasma, and urine samples will be collected.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with adrenocortical carcinoma treated in our center

Inclusion Criteria:

  • Adrenocortical carcinoma
  • Treatment with mitotane intended or mitotane administered

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00568139

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Contact: Martin Fassnacht, MD +49-931-201-36507
Contact: Stefanie Hahner, MD +49-931-201-36508

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University Hospital Recruiting
Wuerzburg, Germany, 97080
Sponsors and Collaborators
University of Wuerzburg
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Principal Investigator: Martin Fassnacht, MD University of Wuerzburg
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Responsible Party: Martin Fassnacht, Head of Endocrinology, University of Wuerzburg Identifier: NCT00568139    
Other Study ID Numbers: Wue-ACC-Mitotane
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: June 2021
Keywords provided by Martin Fassnacht, University of Wuerzburg:
adrenal cancer
mitotane (Lysodren)
adverse events
Additional relevant MeSH terms:
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Adrenocortical Carcinoma
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Adrenal Cortex Diseases
Adrenal Gland Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Endocrine System Diseases