Evaluation of Side Effects of Mitotane

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by University of Wuerzburg
Information provided by (Responsible Party):
Martin Fassnacht, University of Wuerzburg
ClinicalTrials.gov Identifier:
First received: December 4, 2007
Last updated: September 6, 2015
Last verified: September 2015
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

Adrenocortical Carcinoma

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:
  • Documentation of side effects [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Patients with adrenocortical carcinoma treated with mitotane
Patients with adrenocortical carcinoma not treated with mitotane


Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568139

Contact: Martin Fassnacht, MD +49-931-201-36507 fassnacht_m@medizin.uni-wuerzburg.de
Contact: Stefanie Hahner, MD +49-931-201-36508 hahner_s@medizin.uni-wuerzburg.de

University Hospital Recruiting
Wuerzburg, Germany, 97080
Sponsors and Collaborators
University of Wuerzburg
Principal Investigator: Martin Fassnacht, MD University of Wuerzburg
  More Information

Responsible Party: Martin Fassnacht, Head of Endocrinology, University of Wuerzburg
ClinicalTrials.gov Identifier: NCT00568139     History of Changes
Other Study ID Numbers: Wue-ACC-Mitotane 
Study First Received: December 4, 2007
Last Updated: September 6, 2015
Health Authority: Germany: Ethics Commission

Keywords provided by University of Wuerzburg:
adrenal cancer
mitotane (Lysodren)
adverse events

Additional relevant MeSH terms:
Adrenal Gland Neoplasms
Adrenocortical Carcinoma
Adrenal Cortex Diseases
Adrenal Cortex Neoplasms
Adrenal Gland Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Antineoplastic Agents
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on May 25, 2016