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Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00352534
First received: July 13, 2006
Last updated: April 5, 2017
Last verified: May 2016
Results First Received: October 26, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Stage I Wilms Tumor
Stage II Wilms Tumor
Stage III Wilms Tumor
Interventions: Procedure: therapeutic conventional surgery
Drug: vincristine sulfate
Biological: dactinomycin
Drug: doxorubicin hydrochloride
Radiation: 3-dimensional conformal radiation therapy

  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
Stage I/II Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment
Stage III Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.
Very Low Risk Disease Treatment arm. Nephrectomy and re-evaluation,very low-risk disease.
Low Risk, Stage I or II, no LOH Treatment arm. Low risk, stage I or II, no loss of heterozygosity (LOH).
Standard Risk, Stage I or II With LOH Treatment arm. Standard Risk, Stage I or II with LOH.
Standard Risk, Stage III Treatment arm. Standard Risk, Stage III.
High Risk Treatment arm. High risk.

Participant Flow for 2 periods

Period 1:   Initial Staging
    Stage I/II   Stage III   Very Low Risk Disease   Low Risk, Stage I or II, no LOH   Standard Risk, Stage I or II With LOH   Standard Risk, Stage III   High Risk
STARTED   211   597   0   0   0   0   0 
COMPLETED   203   588   0   0   0   0   0 
NOT COMPLETED   8   9   0   0   0   0   0 
Ineligible                8                9                0                0                0                0                0 

Period 2:   Final Risk Group Assignment
    Stage I/II   Stage III   Very Low Risk Disease   Low Risk, Stage I or II, no LOH   Standard Risk, Stage I or II With LOH   Standard Risk, Stage III   High Risk
STARTED   0   0   119   52   32   548   40 
COMPLETED   0   0   116   49   31   503   1 
NOT COMPLETED   0   0   3   3   1   45   39 
Lack of Efficacy                0                0                0                2                1                19                0 
Physician Decision                0                0                0                0                0                8                0 
Withdrawal by Subject                0                0                0                0                0                3                0 
Ineligible                0                0                3                1                0                13                0 
Enrollment onto another COG study                0                0                0                0                0                0                28 
Stage III Wilms tumor with LOH                0                0                0                0                0                0                11 
Death                0                0                0                0                0                2                0 



  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.
Stage I or II: Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment. Stage III: Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.

Reporting Groups
  Description
Stage I or II Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment.
Stage III Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.
Total Total of all reporting groups

Baseline Measures
   Stage I or II   Stage III   Total 
Overall Participants Analyzed 
[Units: Participants]
 211   597   808 
Age 
[Units: Months]
Mean (Standard Deviation)
 23.91  (24.37)   50.62  (30.89)   43.64  (31.83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      110  52.1%      318  53.3%      428  53.0% 
Male      101  47.9%      279  46.7%      380  47.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      38  18.0%      89  14.9%      127  15.7% 
Not Hispanic or Latino      165  78.2%      482  80.7%      647  80.1% 
Unknown or Not Reported      8   3.8%      26   4.4%      34   4.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   0.5%      6   1.0%      7   0.9% 
Asian      2   0.9%      15   2.5%      17   2.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      39  18.5%      89  14.9%      128  15.8% 
White      141  66.8%      417  69.8%      558  69.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      28  13.3%      70  11.7%      98  12.1% 


  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Overall Survival (OS) Probability   [ Time Frame: 4 years ]

3.  Secondary:   Incidence of Contralateral Kidney Lesions   [ Time Frame: During follow-up ]

4.  Secondary:   Incidence of Renal Failure   [ Time Frame: During follow-up ]


  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
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  More Information
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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: NCT00352534     History of Changes
Other Study ID Numbers: AREN0532
NCI-2009-01067 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000487540 ( Other Identifier: ClinicalTrials.gov )
AREN0532 ( Other Identifier: Children's Oncology Group )
AREN0532 ( Other Identifier: CTEP )
U10CA098543 ( US NIH Grant/Contract Award Number )
Study First Received: July 13, 2006
Results First Received: October 26, 2016
Last Updated: April 5, 2017