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Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00335556
First Posted: June 12, 2006
Last Update Posted: July 21, 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: November 28, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Childhood Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma
Clear Cell Sarcoma of the Kidney
Papillary Renal Cell Carcinoma
Rhabdoid Tumor of the Kidney
Stage I Renal Cell Cancer
Stage I Renal Wilms Tumor
Stage II Renal Cell Cancer
Stage II Renal Wilms Tumor
Stage III Renal Cell Cancer
Stage III Renal Wilms Tumor
Stage IV Renal Cell Cancer
Stage IV Renal Wilms Tumor
Interventions: Drug: Doxorubicin Hydrochloride
Drug: Irinotecan Hydrochloride
Procedure: Conventional Surgery
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Carboplatin
Biological: Dactinomycin
Drug: Vincristine Sulfate
Radiation: Radiation Therapy
Other: Laboratory Biomarker Analysis

  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
Surgery Surgery Only
UH-1 Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window/UH-1 Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
UH-2 Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
Regimen I Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.
Regimen DD-4A Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.

Participant Flow:   Overall Study
    Surgery   UH-1   Window/UH-1   UH-2   Regimen I   Regimen DD-4A
STARTED   68   98   7   10   78   30 
COMPLETED   66   64   2   5   77   29 
NOT COMPLETED   2   34   5   5   1   1 
Death                0                5                0                0                1                0 
Lack of Efficacy                0                19                3                3                0                1 
Physician Decision                0                6                2                1                0                0 
Ineligible                2                0                0                0                0                0 
Refusal of further protocol therapy                0                4                0                1                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
Surgery Surgery Only
UH-1 Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
Window/UH-1 Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
UH-2 Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
Regimen I Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.
Regimen DD-4A Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
Total Total of all reporting groups

Baseline Measures
   Surgery   UH-1   Window/UH-1   UH-2   Regimen I   Regimen DD-4A   Total 
Overall Participants Analyzed 
[Units: Participants]
 68   98   7   10   78   30   291 
Age 
[Units: Months]
Mean (Standard Deviation)
 148.53  (51.74)   52.39  (40.09)   68.95  (97.64)   54.04  (19.71)   34.10  (31.10)   54.29  (32.72)   70.60  (60.50) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      28  41.2%      55  56.1%      5  71.4%      7  70.0%      31  39.7%      11  36.7%      137  47.1% 
Male      40  58.8%      43  43.9%      2  28.6%      3  30.0%      47  60.3%      19  63.3%      154  52.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
             
Hispanic or Latino      5   7.4%      8   8.2%      0   0.0%      2  20.0%      15  19.2%      4  13.3%      34  11.7% 
Not Hispanic or Latino      63  92.6%      88  89.8%      6  85.7%      8  80.0%      63  80.8%      25  83.3%      253  86.9% 
Unknown or Not Reported      0   0.0%      2   2.0%      1  14.3%      0   0.0%      0   0.0%      1   3.3%      4   1.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
             
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1   1.5%      1   1.0%      0   0.0%      0   0.0%      3   3.8%      0   0.0%      5   1.7% 
Native Hawaiian or Other Pacific Islander      1   1.5%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   0.3% 
Black or African American      22  32.4%      17  17.3%      1  14.3%      2  20.0%      13  16.7%      5  16.7%      60  20.6% 
White      40  58.8%      72  73.5%      5  71.4%      8  80.0%      55  70.5%      22  73.3%      202  69.4% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      4   5.9%      8   8.2%      1  14.3%      0   0.0%      7   9.0%      3  10.0%      23   7.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)   [ Time Frame: 4 years ]

2.  Primary:   Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors   [ Time Frame: 4 years ]

3.  Primary:   Response Rate   [ Time Frame: Up to 2 months ]

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

5.  Primary:   Toxicity Rate   [ Time Frame: Up to 4 years ]

6.  Secondary:   Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization   [ Time Frame: At baseline ]

7.  Secondary:   Frequency of TP53 Mutations   [ Time Frame: At baseline ]


  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: NCT00335556     History of Changes
Other Study ID Numbers: AREN0321
NCI-2009-00414 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AREN0321 ( Other Identifier: Children's Oncology Group )
CDR0000472893 ( Other Identifier: ClinicalTrials.gov )
AREN0321 ( Other Identifier: Children's Oncology Group )
AREN0321 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: June 8, 2006
First Posted: June 12, 2006
Results First Submitted: November 28, 2016
Results First Posted: June 14, 2017
Last Update Posted: July 21, 2017