We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    AREN0533
Previous Study | Return to List | Next Study

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00379340
First Posted: September 21, 2006
Last Update Posted: June 14, 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: December 6, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Stage III Wilms Tumor With Loss of Heterozygosity (LOH) for 1p and 16q
Stage IV Wilms Tumor
Interventions: Drug: doxorubicin hydrochloride
Drug: liposomal vincristine sulfate
Procedure: conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Biological: dactinomycin
Drug: cyclophosphamide
Drug: etoposide

  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
The 15 discrepant patients were ineligible to the study. They were excluded in the Participant Flow table because none of them were treated by the protocol and their group designations were unknown.

Reporting Groups
  Description
Stage IV and Rapid Complete Response (RCR) of Lung Metastases Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
Stage IV and Slow Incomplete Response (SIR) of Lung Metastases Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
Stage III/IV With LOH 1p and 16q Treated With Regimen M Stage III/IV with LOH 1p and 16q treated with Regimen M.
Stage IV With Non-lung Disease Treated With Regimen M Stage IV with non-lung disease treated with Regimen M.
Stage IV With Lung Metastases Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.

Participant Flow:   Overall Study
    Stage IV and Rapid Complete Response (RCR) of Lung Metastases   Stage IV and Slow Incomplete Response (SIR) of Lung Metastases   Stage III/IV With LOH 1p and 16q Treated With Regimen M   Stage IV With Non-lung Disease Treated With Regimen M   Stage IV With Lung Metastases
STARTED   120   135   52   50   23 
COMPLETED   107   132   50   37   9 
NOT COMPLETED   13   3   2   13   14 
Death                0                0                0                2                0 
Lack of Efficacy                6                1                0                4                3 
Physician Decision                6                2                1                2                3 
Withdrawal by Subject                0                0                0                1                0 
Refusal of further protocol therapy                1                0                1                1                7 
On more than 1 tumor therapeutic study                0                0                0                2                0 
Delayed nephrectomy and anaplasia                0                0                0                1                1 



  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
Stage IV and Rapid Complete Response (RCR) of Lung Metastases Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
Stage IV and Slow Incomplete Response (SIR) of Lung Metastases Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
Stage III/IV With LOH 1p and 16q Treated With Regimen M Stage III/IV with LOH 1p and 16q treated with Regimen M.
Stage IV With Non-lung Disease Treated With Regimen M Stage IV with non-lung disease treated with Regimen M.
Stage IV With Lung Metastases Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
Total Total of all reporting groups

Baseline Measures
   Stage IV and Rapid Complete Response (RCR) of Lung Metastases   Stage IV and Slow Incomplete Response (SIR) of Lung Metastases   Stage III/IV With LOH 1p and 16q Treated With Regimen M   Stage IV With Non-lung Disease Treated With Regimen M   Stage IV With Lung Metastases   Total 
Overall Participants Analyzed 
[Units: Participants]
 120   135   52   50   23   380 
Age 
[Units: Months]
Mean (Standard Deviation)
 54.94  (36.27)   55.07  (27.16)   52.16  (28.64)   69.58  (39.24)   56.06  (23.71)   56.60  (32.29) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      65  54.2%      71  52.6%      30  57.7%      31  62.0%      8  34.8%      205  53.9% 
Male      55  45.8%      64  47.4%      22  42.3%      19  38.0%      15  65.2%      175  46.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Hispanic or Latino      12  10.0%      18  13.3%      6  11.5%      12  24.0%      3  13.0%      51  13.4% 
Not Hispanic or Latino      104  86.7%      108  80.0%      42  80.8%      36  72.0%      18  78.3%      308  81.1% 
Unknown or Not Reported      4   3.3%      9   6.7%      4   7.7%      2   4.0%      2   8.7%      21   5.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native      1   0.8%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   0.3% 
Asian      2   1.7%      2   1.5%      0   0.0%      2   4.0%      1   4.3%      7   1.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      21  17.5%      22  16.3%      10  19.2%      4   8.0%      1   4.3%      58  15.3% 
White      80  66.7%      94  69.6%      38  73.1%      39  78.0%      18  78.3%      269  70.8% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      16  13.3%      17  12.6%      4   7.7%      5  10.0%      3  13.0%      45  11.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Event Free Survival Probability   [ Time Frame: 4 years ]

2.  Primary:   Event Free Survival (EFS) Probability   [ Time Frame: At 4 years ]

3.  Primary:   Event Free Survival Probability   [ Time Frame: At 4 years ]

4.  Secondary:   Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease   [ Time Frame: At 4 years ]


  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: Childrens's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org



Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00379340     History of Changes
Other Study ID Numbers: AREN0533
NCI-2009-00419 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000496508 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
COG-AREN0533 ( Other Identifier: Children's Oncology Group )
First Submitted: September 19, 2006
First Posted: September 21, 2006
Results First Submitted: December 6, 2016
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017