Nowotwór: badanie fazy III leku etoposide i cisplatin

Kryteria wyłączenia kto nie może wziąć udziału (15)

1. The time between primary surgery and randomisation is >90 days
2. Renal insufficiency (estimated glomerular filtration rate [GFR]<50 mL/min/1.73m2) or significant liver insufficiency (serum bilirubin>2 times the upper normal range and/or serum alanine aminotransferase [ALT] or aspartate aminotransferase [AST]>3 times the upper normal range). GFRs will be calculated according to the validated formula (MDRD).
3. Impaired bone marrow reserve (neutrophils< 1000/mm3 and/or platelets < 100,000/mm3)
4. Breast feeding
5. Congestive heart failure defined as having moderate or severe systolic left ventricular dysfunction (ejection fraction<40%). The extent of cardiac testing will depend on the judgment of the local 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 randomised to mitotane who do not have prior cardiac history and have low suspicion for cardiac symptoms to reflect standards of clinical practice. Similarly, utilising cardiac imaging and EKG within the past 12 months is permitted if there is no suspicion for cardiac issues.
6. 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.
7. Preexisting grade 2 peripheral neuropathy
8. Patients that underwent previous or current treatment with mitotane or other antineoplastic drugs for ACC
9. Patients that underwent previous radiotherapy for ACC
10. Contraindication to mitotane, etoposide or cisplatin, as reported in the respective SmPC
11. Gross residual disease after surgery (R2 resection)
12. High suspicion for metastatic disease on perioperative imaging
13. Patients that have undergone repeated surgery for recurrence of disease
14. History of recent or active prior malignancy, except for cured non-melanoma skin cancer, or cured in situ cervical carcinoma, or breast ductal carcinoma in situ, or other treated malignancies where there has been no evidence of disease for at least 2 years.
15. Protected adults (including individual under guardianship by court order) and persons deprived of their liberty by a judicial or administrative decision.