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Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence
Sponsor: M.D. Anderson Cancer Center
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.
Official title: A Randomized Registry Trial of Adjuvant Mitotane vs. Mitotane With Cisplatin/Etoposide After Primary Surgical Resection of Localized Adrenocortical Carcinoma With High Risk of Recurrence (ADIUVO-2 Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2018-08-20
Completion Date
2029-01-01
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Cisplatin
Given IV
Etoposide
Given IV
Mitotane
Given PO
Quality-of-Life Assessment
Ancillary studies
Locations (33)
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Siteman Cancer Center at Washington University
St Louis, Missouri, United States
M D Anderson Cancer Center
Houston, Texas, United States
Institut de Cancérologie de l'Ouest (ICO)
Angers, France
CHU Angers, Hôpital Larrey
Angers, France
CHU Besançon, Hôpital Jean Minjoz
Besançon, France
CHU Brest, Hôpital La Cavale Blanche
Brest, France
Centre Georges François Leclerc
Dijon, France
Lyon HCL
Lyon, France
HCL Hôpital Louis Pradel
Lyon, France
Marseille Hôpital Nord
Marseille, France
Marseille Hôpital de la Conception
Marseille, France
CHU Nantes, Hôpital René et Guillaume Laënnec
Nantes, France
CHU Nantes, Hôpital René et Guillaume Laënnec
Nantes, France
Hôpital Cochin, AP-HP
Paris, France
Hôpital Cochin, AP-HP
Paris, France
Hôpital Cochin
Paris, France
Hôpital COCHIN
Paris, France
CHU Bordeaux - Hôpital Haut Lévèque
Pessac, France
CHU Poitiers
Poitiers, France
CHU Reims
Reims, France
HUS, Hôpital Hautepierre
Strasbourg, France
Strasbourg HUS Hautepierre
Strasbourg, France
CHU Toulouse, Hôpital Larrey
Toulouse, France
CHU Toulouse, Hôpital Rangueil
Toulouse, France
Gustave Roussy
Villejuif, France
LMU Klinikum München
Munich, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Maria Sklodowska-Curie National Research Institute of Oncology
Gliwice, Poland
Sahlgrenska University Hospital
Gothenburg, Sweden
Skånes Universitetssjukhus
Lund, Sweden
Karolinska University Hospital
Stockholm, Sweden
Akademiska Sjukhuset
Uppsala, Sweden