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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00924144




Registration number
NCT00924144
Ethics application status
Date submitted
19/10/2004
Date registered
20/10/2004
Date last updated
21/09/2016

Titles & IDs
Public title
Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)
Scientific title
First International Randomized Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment
Secondary ID [1] 0 0
CO-ACT-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Adrenal Cortical 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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 verifiable afterwards.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 place 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
304
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Collaborative Group for Adrenocortical Carcinoma Treatment
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether treatment with etoposide, doxorubicin, cisplatin and mitotane (EDP/M) prolongs survival as compared to streptozotocin and mitotane (Sz/M) in patients with advanced adrenocortical carcinoma (ACC) whose disease is not amenable to complete surgical resection.
Trial website
https://clinicaltrials.gov/study/NCT00924144
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Britt Skogseid, MD
Address 0 0
Uppsala University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00924144