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Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)

This study has been completed.
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Martin Fassnacht, Collaborative Group for Adrenocortical Carcinoma Treatment
ClinicalTrials.gov Identifier:
NCT00094497
First received: October 19, 2004
Last updated: September 19, 2016
Last verified: September 2016
Results First Received: September 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Adrenal Cortical
Interventions: Drug: Etoposide
Drug: Doxorubicin
Drug: Cisplatin
Drug: Streptozotocin
Drug: Mitotane

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
EDP-M

etopodide, doxorubicin, cisplatin and mitotane

Etoposide

Doxorubicin

Cisplatin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)

Sz-M

streptozotocin and mitotane

Streptozotocin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)


Participant Flow:   Overall Study
    EDP-M     Sz-M  
STARTED     151     153  
Treated     148     149  
Received Second Line Therapy     84     101  
COMPLETED     151     153  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
EDP-M

etopodide, doxorubicin, cisplatin and mitotane

Etoposide

Doxorubicin

Cisplatin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)

Sz-M

streptozotocin and mitotane

Streptozotocin

Mitotane

participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)

Total Total of all reporting groups

Baseline Measures
    EDP-M     Sz-M     Total  
Number of Participants  
[units: participants]
  151     153     304  
Age, Customized  
[units: participants]
     
>= 18 years     151     153     304  
Gender  
[units: participants]
     
Female     91     92     183  
Male     60     61     121  
tumor stage  
[units: participants]
     
III     0     1     1  
IV     151     152     303  
ECOG [1]
[units: participants]
     
0     73     72     145  
1     64     60     124  
2     13     21     34  
4     1     0     1  
[1] Eastern Cooperative Oncology Group performance status score (ranges from 0, asymptomatic - 5, dead)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: every 8 weeks until death up to 5 years ]

2.  Secondary:   Progression-free Survival   [ Time Frame: every 8 weeks until progression or death up to 5 years ]

3.  Secondary:   Change in Quality of Life as Measured by QLQ-C30   [ Time Frame: baseline and 8 weeks ]

4.  Secondary:   Best Overall Response Rate   [ Time Frame: every 8 weeks up to 5 years ]

5.  Secondary:   Number of Disease-free Patients   [ Time Frame: every 8 weeks until progression (up to 5 years) ]

6.  Other Pre-specified:   TTP of Both Regimens as Second Line Treatment in Case of Failure of the Other Initial Regime   [ Time Frame: every 8 weeks until progression or until Dec 2010 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Other Pre-specified:   Pharmakinetics of Mitotane (Substudy)   [ Time Frame: 11 time points in the first 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Other Pre-specified:   Impact of Reaching Mitotane Blood Levels Between 14-20 mg/l in Both Arms on Survival and Overall Response Rate   [ Time Frame: every 8 weeks until progression or until Dec 2010 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Martin Fassnacht
Organization: University Hospital of Wuerzburg, Germany
phone: +49-931-201-39021
e-mail: fassnacht_m@ukw.de


Publications of Results:

Responsible Party: Martin Fassnacht, Collaborative Group for Adrenocortical Carcinoma Treatment
ClinicalTrials.gov Identifier: NCT00094497     History of Changes
Obsolete Identifiers: NCT00924144
Other Study ID Numbers: CO-ACT-001
Study First Received: October 19, 2004
Results First Received: September 19, 2016
Last Updated: September 19, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Netherlands: Independent Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration