Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
M.D. Anderson Cancer Center (Voir sur ClinicalTrials)
août 2018
janvier 2029
02 octobre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | LIBE Rossella | 18/10/2025 09:44:45 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 18/10/2025 09:44:43 | Contacter | |||
| AP-HP - Hôpital Cochin | |||||
Critères
Tous
- 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), or undetermined margins (RX, based on
surgical or pathological reports without unequivocal evidence of metastasis in the
perioperative imaging). Each participating center will determine the pathological
stages and resection margins AND Ki67 > 10% (to be determined by an experienced
pathologist in each participating center and preferably via quantitative imaging
analysis).
- Have perioperative imaging (computed tomography [CT] with contrast, magnetic
resonance imaging [MRI] of the chest/abdomen/pelvis, or fluorodeoxyglucose positron
emission tomography [FDG-PET] CT) without unequivocal evidence of disease within 8
weeks before randomization. Patients with indeterminate non-specific nodules (< 1 cm
for soft tissue lesions and < 1.5 cm in the short dimension for lymph nodes) will be
permitted to participate in this study.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Be able to comply with the protocol procedures.
- Provide written informed consent.
Exclusion Criteria:
- The time between primary surgery and randomization > 90 days.
- Gross residual disease after surgery (R2 resection)
- High suspicion for metastatic disease on perioperative imaging
- They have undergone repeated surgery for recurrence of disease.
- They have a history of recent or active prior malignancy, except for cured
non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma
in situ, or other treated malignancies where there has been no evidence of disease
for at least 2 years.
- They have renal insufficiency (estimated glomerular filtration rate [GFR] < 50
mL/min/1.73 m^2).
- They have significant liver insufficiency (serum bilirubin > 2 times the upper
normal range)
- They have significant liver insufficiency (serum alanine aminotransferase [ALT] or
aspartate aminotransferase [AST] > 3 times the upper normal range)
- Impaired bone marrow reserve (neutrophils < 1000/mm^3)
- Impaired bone marrow reserve (platelets < 100,000/mm^3)
- Pregnancy or breast feeding.
- They have known congestive heart failure (ejection fraction < 45%). The extent of
cardiac testing will depend on the judgment of the local principal investigator
(PI). In general, in patients with a history of cardiac disease, it is recommended
to obtain a baseline two-dimensional echocardiogram as standard of care to document
ejection fraction. In patients without prior cardiac disease, a baseline
electrocardiogram (EKG) is sufficient if there is no evidence of acute ischemic
changes or prior evidence of myocardial infarction. If EKG results are abnormal
(ischemic changes, significant arrhythmia, or suggestion of prior myocardial
infarction), a two-dimensional echocardiogram will be obtained to assess ejection
fraction. Cardiac imaging and EKG may not be needed in patients assigned to mitotane
who do not have prior cardiac history and have low suspicion for cardiac symptoms to
reflect standards of clinical practice. Similarly, utilizing cardiac imaging and EKG
within the past 12 months is permitted if there is no suspicion for cardiac issues.
- They have preexisting grade 2 peripheral neuropathy.
- They underwent previous or current treatment with mitotane or other antineoplastic
drugs for ACC.
- They underwent previous radiotherapy for ACC.
- They have any other severe acute or chronic medical or psychiatric condition or
laboratory abnormality that would, in the judgment of the investigator, pose excess
risk associated with study participation or administration of the involved drugs or
that, in the judgment of the investigator, would make the patient inappropriate for
entry into this study.