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This study evaluates cisplatin-based chemotherapy and/or surgery in children and young patients with an adrenocortical tumor (adrenal gland cancer). It included newly diagnosed patients with confirmed adrenocortical carcinoma. It was a Phase 3 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Histologically confirmed adrenocortical carcinoma * Newly diagnosed disease within the past 3 weeks * Any disease stage allowed * Lansky performance status 60-100% (for patients ≤ 16 years old) * Karnofsky performance status 60-100% (for patients \> 16 years old) * Absolute neutrophil count ≥ 750/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age as follows: * 0.4 mg/dL (1 month to \< 6 months) * 0.5 mg/dL (6 months to \< 1 year of age) * 0.6 mg/dL (1 to \< 2 years of age * 0.8 mg/dL (2 to \< 6 years of age) * 1.0 mg/dL (6 to \< 10 years of age) * 1.2 mg/dL (10 to \< 13 years of age) * 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to \< 16 years of age) * 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age) * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST or ALT \< 2.5 times ULN * Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No previous chemotherapy for adrenocortical carcinoma