About this trial
This trial looks at how well mitotane works by itself compared to when it is combined with cisplatin and etoposide after surgery. It focuses on patients with adrenocortical cancer that has a high chance of coming back. Doctors want to see which treatment helps more in preventing the cancer from returning. They are also interested in side effects and how treatment affects patients' quality of life.
The trial ID is NCT03583710. It is a Phase 3 trial, meaning it is looking at the effectiveness and safety of the treatments. The study hopes to include around 240 participants and is FDA-regulated.
Who can join
Adults aged 18 and older can join this trial. It is open to both men and women who have been diagnosed with adrenocortical cancer and have a high risk of recurrence. Participants must be able to follow the study rules and give consent. Some health issues may prevent participation, and the trial team will confirm eligibility.
Conditions
ENSAT Stage I Adrenal Cortex Carcinoma, ENSAT Stage II Adrenal Cortex Carcinoma, ENSAT Stage III Adrenal Cortex Carcinoma
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed into one of two groups. In Arm A, they will take mitotane by mouth every day for 21 days, repeating this cycle for 2 years. In Arm B, participants will also take mitotane, but they will receive cisplatin and etoposide through an IV on specific days. This group will repeat their treatment every 21 days for up to 4 cycles.
Where
This trial is running at 3 locations in the United States. 2 of them are currently recruiting.
M D Anderson Cancer Center
Houston, Texas
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan
Siteman Cancer Center at Washington University
St Louis, Missouri