Clinical Trial

Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence

Recruiting Phase 3
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Summary
This phase III trial studies how well mitotane alone works compared to mitotane with cisplatin and etoposide when given after surgery in treating patients with adrenocortical cancer that has a high risk of coming back (recurrence). Cortisol can cause the growth of adrenocortical tumor cells. Antihormone therapy, such as mitotane, may lessen the amount of cortisol made by the body. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether mitotane alone or mitotane with cisplatin and etoposide after surgery works better in treating patients with adrenocortical carcinoma.
Protocol Amendment History 1 change
notable Trial sites expanded: 25 -> 33 locations 2026-04-08
Trial Details
NCT Number NCT03583710
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions ENSAT Stage I Adrenal Cortex Carcinoma, ENSAT Stage II Adrenal Cortex Carcinoma, ENSAT Stage III Adrenal Cortex Carcinoma
Enrollment 240 participants
Start Date 2018-08-20
Primary Completion 2029-01-01 (estimated)
Study Completion 2029-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-16