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)
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.
Description
PRIMARY OBJECTIVE: I. To compare the effect of adjuvant mitotane treatment alone (arm A) with that of adjuvant mitotane combined with four 21-day cycles of etoposide/cisplatin (arm B) on recurrence-free survival (RFS) in patients with high-risk adrenocortical carcinoma (ACC) after initial surgical resection. SECONDARY OBJECTIVES: I. Assess overall survival (OS), defined as the time interval between the date of randomization and the date of death from any cause. II. Assess the effect of serum mitotane levels, disease stage, and surgical resection margins on clinical outcomes. III. Assess t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have a histologically confirmed diagnosis of ACC (Weiss score of \>= 3). (LinWeiss-Bisceglia system will be used for oncocytic ACC). * Have a high risk of relapse defined as: Stage I-III ACC (according to the European Network for the Study of Adrenal Tumors \[ENSAT\] classification) within 90 days of surgical resection of primary tumor with curative intent with either microscopically complete resection (R0, defined as no evidence of microscopic residual disease according to surgical reports, histopathology, and perioperative imaging), microscopically positive margins (R1…
Interventions
- DrugCisplatin
Given IV
- DrugEtoposide
Given IV
- DrugMitotane
Given PO
- OtherQuality-of-Life Assessment
Ancillary studies
Locations (33)
- University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan
- Siteman Cancer Center at Washington UniversitySt Louis, Missouri
- M D Anderson Cancer CenterHouston, Texas
- Institut de Cancérologie de l'Ouest (ICO)Angers
- CHU Angers, Hôpital LarreyAngers
- CHU Besançon, Hôpital Jean MinjozBesançon