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FIRM-ACT: First International Randomized trial on locally advanced and Metastatic Adrenocortical Carcinoma Treatment

The purpose of this clinical trial is to compare two chemotherapy protocols used in the treatment of patients with advanced adrenocortical carcinoma.

Taking part in this study is completely voluntary. Participants may also leave the study at any time. Those who leave the study before it is finished are not penalized and will not lose any benefits to which they are otherwise entitled.

Who can take part in this study?

Patients 18 years of age or older in stages III or IV adrenocortical carcinoma. To be included, you should have:

Histologically confirmed diagnosis of adrenocortical carcinoma, locally advanced or metastatic disease not amenable to radical surgery resection (Stage III-IV), radiologically monitorable disease, ECOG performance status 0-2, life expectancy greater than 3 months, adequate bone marrow reserve (neutrophils greater than or equal to 1,500/mm3 and platelets greater than or equal to 100,000/mm3), effective contraception (in both pre-menopausal female and male patients), given written informed consent, and you are able to comply with the protocol procedures (including availability for follow-up visits). You will not be able to be included in this study if you have a history of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other cancers treated with no evidence of disease for at least five years; previous cytotoxic chemotherapy for adrenocortical carcinoma, renal insufficiency (serum creatinine greater than or equal to 2 mg/dl or creatinine clearance less than or equal to 50 ml/min) or hepatic insufficiency (serum bilirubin greater than or equal to 2 x the institutional upper limit of normal range and/or serum transaminases greater than or equal to 3 x the institutional upper limit of normal range).

How can you get enrolled in this study?

Please contact the researchers listed below to:

Principal Investigator:

Study Coordinator:

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