We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304070
First Posted: March 17, 2006
Last Update Posted: June 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
Results First Submitted: October 21, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Stage I Adrenocortical Carcinoma
Stage II Adrenocortical Carcinoma
Stage III Adrenocortical Carcinoma
Stage IV Adrenocortical Carcinoma
Interventions: Drug: doxorubicin hydrochloride
Procedure: conventional surgery
Drug: cisplatin
Drug: mitotane
Drug: etoposide
Biological: filgrastim

  Participant Flow
  Hide Participant Flow

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
Stratum 1 Stage I Disease (surgery, observation)
Stratum 2 Stage II Disease (surgery, observation)
Stratum 3 Stage III OR IV Disease (chemotherapy)

Participant Flow:   Overall Study
    Stratum 1   Stratum 2   Stratum 3
STARTED   24   15   39 
COMPLETED   21   8   27 
NOT COMPLETED   3   7   12 
Death                0                0                3 
Lost to Follow-up                0                0                1 
Physician Decision                0                0                3 
Withdrawal by Subject                0                0                1 
Progressive Disease                3                7                4 



  Baseline Characteristics
  Hide Baseline Characteristics

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
Stratum 1 Stage I Disease (surgery, observation)
Stratum 2 Stage II Disease (surgery, observation)
Stratum 3 Stage III OR IV Disease (chemotherapy)
Total Total of all reporting groups

Baseline Measures
   Stratum 1   Stratum 2   Stratum 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   15   39   78 
Age 
[Units: Years]
Mean (Full Range)
 2 
 (0 to 12) 
 3 
 (0 to 12) 
 7 
 (0 to 20) 
 5 
 (0 to 20) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      14  58.3%      10  66.7%      27  69.2%      51  65.4% 
Male      10  41.7%      5  33.3%      12  30.8%      27  34.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      12  50.0%      7  46.7%      16  41.0%      35  44.9% 
Not Hispanic or Latino      9  37.5%      8  53.3%      20  51.3%      37  47.4% 
Unknown or Not Reported      3  12.5%      0   0.0%      3   7.7%      6   7.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      1   4.2%      0   0.0%      1   2.6%      2   2.6% 
Asian      1   4.2%      2  13.3%      1   2.6%      4   5.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   4.2%      1   6.7%      2   5.1%      4   5.1% 
White      15  62.5%      12  80.0%      28  71.8%      55  70.5% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      6  25.0%      0   0.0%      7  17.9%      13  16.7% 
Region of Enrollment 
[Units: Participants]
       
Canada   0   2   3   5 
United States   12   7   24   43 
Brazil   12   6   12   30 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Five Year Event-free Survival (EFS)   [ Time Frame: Up to five years after enrollment ]

2.  Secondary:   Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0   [ Time Frame: Up to 182 Days After Enrollment ]

3.  Secondary:   Complications Associated With Radical Adrenalectomy and RLND   [ Time Frame: Up to 1 month after surgery ]

4.  Secondary:   Frequency of Lymph Node Involvement by Imaging.   [ Time Frame: At study enrollment ]

5.  Secondary:   Incidence and Type of Germline TP53 Mutations in Non-Brazilian Children and Children From Southern Brazil by Deoxyribonucleic Acid (DNA) Sequencing and Affymetrix Gene Chip Analysis.   [ Time Frame: At study enrollment ]

6.  Secondary:   Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin.   [ Time Frame: Patients who had surgery at time of enrollment. ]

7.  Secondary:   Frequency of Tumor Spillage at the Time of Tumor Resection   [ Time Frame: Up to one year or while on protocol therapy, whichever is less ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org



Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00304070     History of Changes
Other Study ID Numbers: ARAR0332
NCI-2009-00413 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000467191
COG-ARAR0332
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: March 15, 2006
First Posted: March 17, 2006
Results First Submitted: October 21, 2016
Results First Posted: June 12, 2017
Last Update Posted: June 12, 2017