RecruitingPhase 3NCT03583710

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

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)

Sponsor

M.D. Anderson Cancer Center

Enrollment

240 participants

Start Date

Aug 20, 2018

Study Type

INTERVENTIONAL

Conditions

ENSAT Stage I Adrenal Cortex Carcinoma ENSAT Stage II Adrenal Cortex Carcinoma ENSAT Stage III Adrenal Cortex Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding chemotherapy drugs (cisplatin and etoposide) to a standard drug called mitotane improves outcomes for patients with a rare adrenal gland cancer (adrenocortical carcinoma) after surgery, in cases where the cancer is at high risk of coming back. **You may be eligible if...** - You have been diagnosed with adrenocortical carcinoma (ACC), confirmed by biopsy with a Weiss score of 3 or higher - Your cancer is at stage I, II, or III (not yet spread to distant organs) - You had surgery to remove the tumor within the last 90 days with the goal of curing the disease - Your surgery achieved complete or near-complete removal of the tumor **You may NOT be eligible if...** - Your cancer is at stage IV (has spread to distant parts of the body) - Surgery was performed more than 90 days ago - The tumor could not be mostly removed during surgery - Your overall health does not meet the required standards Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCisplatin

Given IV

DRUGEtoposide

Given IV

DRUGMitotane

Given PO

OTHERQuality-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

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NCT03583710