FIRM-ACT version 1
Research type
Research Study
Full title
First International Randomized trial in locally advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)
Sponsor organisation
University Hospital Uppsala
Eudract number
Eudra CT 2005-004137-18
Clinicaltrials.gov Identifier
Research summary
Adrenocortical carcinoma (ACC) is a rare disease with an extremely poor prognosis. The incidence is approximately 1-2 per million population per year. In a recent study, the median survival in stage IV disease was 25 weeks. Due to this poor survival and low incidence of ACC, single centres or even single countries have been unable to collect sufficient number of patients to conduct a reliable evaluation of treatment options. Therefore this international study was established to look at treatment of stage IV ACC in patients from 11 different countries to enable sufficient patients to be obtained.The study will try to answer which of two different chemotherapy regimens, both already used in clinical practice, is the best to start with in patients with stage IV adrenocortical cancer that cannot be treated radically by surgery. All drugs included in the study protocol have previously been reported to be efficient in treating adrenocortical cancer at advanced stages but they have different profiles of side effects. Specifically the study compares the efficacy of etoposide, doxorubicin and cisplatin plus mitotane as first line treatment versus streptozotocin plus mitotane as first line treatment in advanced stages of ACC.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
09/H1208/18
Date of REC Opinion
27 Jul 2009
REC opinion
Further Information Favourable Opinion