First International Randomized trial in locally advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004137-18-AT

Enrollment

300

Registered

2006-07-21

Start date

2007-10-19

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chemotherapy with etoposide, doxorubicin and cisplatin plus mitotane (EDP/M) as first line treatment versus streptozotocin plus mitotane (Sz/M) as first line treatment in advanced and Metastatic Adrenocortical Carcinoma MedDRA version: 8.1 Level: LLT Classification code 10001388 Term: Adrenocortical carcinoma

Interventions

Product Name: etoposid Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ETOPOSIDE CAS Number: 33419420 Current Sponsor code: 8983 Other descriptive name: Vepesid Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 > 3 months Age =18 years Adequate bone marrow reserve (neutrophils =1500/mm3 and platelets =100.000/mm3) Effective contraception in pre-menopausal female and male patients Patient’s written informed consent Ability to comply with the protocol procedures (including availability for follow-up visits) Previous palliative surgery, radiotherapy or radiofrequency ablation is acceptable as long as radiologically monitorable disease is verifiably afterwards. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: History of prior malignancy, except for cured non-melanoma skin cancer, curatively 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 =2 mg/dl or creatinine clearance = 50 ml/min) Hepatic insufficiency (serum bilirubin =2 x the institutional upper limit of normal range and/or serum transaminases = 3 x the institutional upper limit of normal range; exception: in patients on mitotane transaminase levels up to 5 x the institutional upper limit of normal range are acceptable) Pregnancy or breast feeding Known hypersensitivity to any drug included in the treatment protocol Presence of active infection Any other severe clinical condition that in the judgment of the local investigator would lace the patient at undue risk or interfere with the study completion Decompensated heart failure (ejection fraction <50%), myocardial infarction or revascularization procedure during the last 6 months, unstable angina pectoris, and uncontrolled cardiac arrhythmia Current treatment with other experimental drugs and/or previous participation in clinical trials with other experimental agents for adrenocortical carcinoma Prisoners

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy of etoposide, doxorubicin and cisplatin plus mitotane (EDP/M) as first line treatment versus streptozotocin plus mitotane (Sz/M) as first line treatment Study design Randomized, prospective, controlled,;Secondary Objective: quality of life time to progression;Primary end point(s): Primary endpoint: to compare overall survival	—

Countries

Austria, Norway

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026