Actively Recruiting
Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence
Led by M.D. Anderson Cancer Center · Updated on 2026-04-07
240
Participants Needed
33
Research Sites
541 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of adrenocortical carcinoma with Weiss score ≥ 3
- High risk of relapse with stage I-III ACC by ENSAT classification within 90 days after surgery
- Surgical resection with either complete (R0), microscopically positive (R1), or undetermined margins (RX)
- Ki67 index greater than 10% determined by an experienced pathologist
- Perioperative imaging without clear evidence of disease within 8 weeks before randomization
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Ability to follow study procedures
- Provided written informed consent
You will not qualify if you...
- More than 90 days between primary surgery and randomization
- Gross residual disease after surgery (R2 resection)
- High suspicion of metastatic disease on imaging
- Previous repeated surgery for disease recurrence
- Recent or active prior malignancy except for certain cured cancers with no disease for 2 years
- Renal insufficiency with estimated GFR < 50 mL/min/1.73 m²
- Significant liver insufficiency with bilirubin > 2 times normal or ALT/AST > 3 times normal
- Impaired bone marrow reserve with neutrophils < 1000/mm³ or platelets < 100,000/mm³
- Pregnancy or breastfeeding
- Known congestive heart failure with ejection fraction < 45%
- Preexisting grade 2 peripheral neuropathy
- Previous or current treatment with mitotane or other chemotherapy for ACC
- Previous radiotherapy for ACC
- Any other severe acute or chronic medical or psychiatric condition or lab abnormality that poses excess risk or makes patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
2
Siteman Cancer Center at Washington University
St Louis, Missouri, United States, 63110
Active, Not Recruiting
3
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
4
Institut de Cancérologie de l'Ouest (ICO)
Angers, France, 49055
Active, Not Recruiting
5
CHU Angers, Hôpital Larrey
Angers, France, 49933
Actively Recruiting
6
CHU Besançon, Hôpital Jean Minjoz
Besançon, France, 25000
Actively Recruiting
7
CHU Brest, Hôpital La Cavale Blanche
Brest, France, 29200
Active, Not Recruiting
8
Centre Georges François Leclerc
Dijon, France, 25000
Actively Recruiting
9
Lyon HCL
Lyon, France, 69002
Actively Recruiting
10
HCL Hôpital Louis Pradel
Lyon, France, 69877
Not Yet Recruiting
11
Marseille Hôpital Nord
Marseille, France, 13015
Actively Recruiting
12
Marseille Hôpital de la Conception
Marseille, France
Actively Recruiting
13
CHU Nantes, Hôpital René et Guillaume Laënnec
Nantes, France, 44093
Active, Not Recruiting
14
CHU Nantes, Hôpital René et Guillaume Laënnec
Nantes, France, 44093
Actively Recruiting
15
Hôpital Cochin, AP-HP
Paris, France, 75014
Actively Recruiting
16
Hôpital Cochin, AP-HP
Paris, France, 75014
Active, Not Recruiting
17
Hôpital Cochin
Paris, France, 75014
Actively Recruiting
18
Hôpital COCHIN
Paris, France, 75014
Active, Not Recruiting
19
CHU Bordeaux - Hôpital Haut Lévèque
Pessac, France, 33600
Actively Recruiting
20
CHU Poitiers
Poitiers, France, 86000
Actively Recruiting
21
CHU Reims
Reims, France, 51092
Actively Recruiting
22
HUS, Hôpital Hautepierre
Strasbourg, France, 67000
Not Yet Recruiting
23
Strasbourg HUS Hautepierre
Strasbourg, France, 67000
Active, Not Recruiting
24
CHU Toulouse, Hôpital Larrey
Toulouse, France, 31059
Actively Recruiting
25
CHU Toulouse, Hôpital Rangueil
Toulouse, France, 31400
Active, Not Recruiting
26
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
27
LMU Klinikum München
Munich, Germany, 80336
Actively Recruiting
28
Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Actively Recruiting
29
Maria Sklodowska-Curie National Research Institute of Oncology
Gliwice, Poland, 44-102
Active, Not Recruiting
30
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
31
Skånes Universitetssjukhus
Lund, Sweden
Actively Recruiting
32
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
33
Akademiska Sjukhuset
Uppsala, Sweden
Actively Recruiting
Research Team
J
Jeena Varghese
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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