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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00094497




Registration number
NCT00094497
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
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: EDP-M - etopodide, doxorubicin, cisplatin and mitotane

Active comparator: Sz-M - streptozotocin and mitotane
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
every 8 weeks until death up to 5 years
Secondary outcome [1] 0 0
Progression-free Survival
Timepoint [1] 0 0
every 8 weeks until progression or death up to 5 years
Secondary outcome [2] 0 0
Change in Quality of Life as Measured by QLQ-C30
Timepoint [2] 0 0
baseline and 8 weeks
Secondary outcome [3] 0 0
Best Overall Response Rate
Timepoint [3] 0 0
every 8 weeks up to 5 years
Secondary outcome [4] 0 0
Number of Disease-free Patients
Timepoint [4] 0 0
every 8 weeks until progression (up to 5 years)

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)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
Austria
State/province [3] 0 0
Graz
Country [4] 0 0
France
State/province [4] 0 0
Lille
Country [5] 0 0
France
State/province [5] 0 0
Lyon
Country [6] 0 0
France
State/province [6] 0 0
Marseille
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
France
State/province [8] 0 0
Pessac
Country [9] 0 0
France
State/province [9] 0 0
Villejuif
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Dresden
Country [12] 0 0
Germany
State/province [12] 0 0
Duesseldorf
Country [13] 0 0
Germany
State/province [13] 0 0
Essen
Country [14] 0 0
Germany
State/province [14] 0 0
Hannover
Country [15] 0 0
Germany
State/province [15] 0 0
Magdeburg
Country [16] 0 0
Germany
State/province [16] 0 0
Mainz
Country [17] 0 0
Germany
State/province [17] 0 0
Munich
Country [18] 0 0
Germany
State/province [18] 0 0
Wuerzburg
Country [19] 0 0
Italy
State/province [19] 0 0
Orbassano
Country [20] 0 0
Italy
State/province [20] 0 0
Padova
Country [21] 0 0
Netherlands
State/province [21] 0 0
Amsterdam
Country [22] 0 0
Netherlands
State/province [22] 0 0
Eindhoven
Country [23] 0 0
Netherlands
State/province [23] 0 0
Groningen
Country [24] 0 0
Netherlands
State/province [24] 0 0
Leiden
Country [25] 0 0
Sweden
State/province [25] 0 0
Gothenburg
Country [26] 0 0
Sweden
State/province [26] 0 0
Linköping
Country [27] 0 0
Sweden
State/province [27] 0 0
Lund
Country [28] 0 0
Sweden
State/province [28] 0 0
Stockholm
Country [29] 0 0
Sweden
State/province [29] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Other
Name
Collaborative Group for Adrenocortical Carcinoma Treatment
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
German Federal Ministry of Education and Research
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Cancer Institute (NCI)
Address [2] 0 0
Country [2] 0 0

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/NCT00094497
Trial related presentations / publications
Fassnacht M, Terzolo M, Allolio B, Baudin E, Haak H, Berruti A, Welin S, Schade-Brittinger C, Lacroix A, Jarzab B, Sorbye H, Torpy DJ, Stepan V, Schteingart DE, Arlt W, Kroiss M, Leboulleux S, Sperone P, Sundin A, Hermsen I, Hahner S, Willenberg HS, Tabarin A, Quinkler M, de la Fouchardiere C, Schlumberger M, Mantero F, Weismann D, Beuschlein F, Gelderblom H, Wilmink H, Sender M, Edgerly M, Kenn W, Fojo T, Muller HH, Skogseid B; FIRM-ACT Study Group. Combination chemotherapy in advanced adrenocortical carcinoma. N Engl J Med. 2012 Jun 7;366(23):2189-97. doi: 10.1056/NEJMoa1200966. Epub 2012 May 2.
Public notes

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/NCT00094497