- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00568139
Evaluation of Side Effects of Mitotane
September 21, 2023 updated by: Martin Fassnacht, University of Wuerzburg
Evaluierung Von Nebenwirkungen Einer Therapie Mit Mitotane Beim Nebennierenkarzinom- Evaluation of Side Effects of Mitotane in Adrenocortical Carcinoma
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
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Martin Fassnacht, MD
- Phone Number: +49-931-201-36507
- Email: fassnacht_m@medizin.uni-wuerzburg.de
Study Contact Backup
- Name: Stefanie Hahner, MD
- Phone Number: +49-931-201-36508
- Email: hahner_s@medizin.uni-wuerzburg.de
Study Locations
-
-
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Wuerzburg, Germany, 97080
- Recruiting
- University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with adrenocortical carcinoma treated in our center or other ENSAT centers
Description
Inclusion Criteria:
- Adrenocortical carcinoma
- Treatment with mitotane monotherapy as first-line therapy (in adjuvant setting or advanced disease)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Mitotane
Patients with adrenocortical carcinoma treated with mitotane monotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Documentation of adverse effects
Time Frame: 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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin Fassnacht, MD, University of Wuerzburg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2008
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
December 4, 2007
First Submitted That Met QC Criteria
December 4, 2007
First Posted (Estimated)
December 5, 2007
Study Record Updates
Last Update Posted (Actual)
September 26, 2023
Last Update Submitted That Met QC Criteria
September 21, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Wue-ACC-Mitotane
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adrenocortical Carcinoma
-
National Cancer Institute (NCI)TerminatedRecurrent Adrenocortical Carcinoma | Stage III Adrenocortical Carcinoma | Stage IV Adrenocortical CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Adrenocortical Carcinoma | Stage III Adrenocortical Carcinoma | Stage IV Adrenocortical CarcinomaUnited States
-
Dartmouth-Hitchcock Medical CenterM.D. Anderson Cancer Center; Dana-Farber Cancer Institute; AstraZeneca; Kentuckiana...CompletedNonresectable Adrenocortical CarcinomaUnited States
-
Latin American Cooperative Oncology GroupNot yet recruitingCarcinoma Adrenal | Carcinoma, Adrenocortical RecurrentBrazil
-
Memorial Sloan Kettering Cancer CenterRecruitingAdrenocortical Carcinoma | ACC | Metastatic Adrenocortical CarcinomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedAdrenocortical Carcinoma
-
Burzynski Research InstituteTerminatedStage IV Adrenocortical CarcinomaUnited States
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National Cancer Institute (NCI)CompletedAdrenal Cortex NeoplasmsUnited States
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-
University Medical Center GroningenRadboud University Medical Center; Maastricht University Medical Center; UMC... and other collaboratorsRecruitingAdrenocortical Carcinoma | Adrenal IncidentalomaNetherlands