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Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00354835
First Posted: July 20, 2006
Last Update Posted: July 25, 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: July 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Malignant Mesenchymoma
Adult Rhabdomyosarcoma
Childhood Alveolar Rhabdomyosarcoma
Childhood Botryoid-Type Embryonal Rhabdomyosarcoma
Childhood Embryonal Rhabdomyosarcoma
Childhood Malignant Mesenchymoma
Non-Metastatic Childhood Soft Tissue Sarcoma
Stage I Adult Soft Tissue Sarcoma
Stage II Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Untreated Childhood Rhabdomyosarcoma
Interventions: Drug: Irinotecan Hydrochloride
Biological: Dactinomycin
Drug: Cyclophosphamide
Drug: Vincristine Sulfate
Radiation: Radiation Therapy
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration

  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
481 excludes 33 ineligible cases (declared by the Study Chair) .

Reporting Groups
  Description
Vincristine, Dactinomycin, Cyclophosphamide (VAC)

Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.

Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies

VAC Alternating With Vincristine, Irinotecan (VI) Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.

Participant Flow:   Overall Study
    Vincristine, Dactinomycin, Cyclophosphamide (VAC)   VAC Alternating With Vincristine, Irinotecan (VI)
STARTED   239   242 
COMPLETED   187   181 
NOT COMPLETED   52   61 
Death                1                1 
Physician Decision                8                13 
Withdrawal by Subject                2                1 
Ineligible                17                16 
Disease progression or relapse                15                22 
Adverse Event                6                0 
Refusal of further therapy                3                8 



  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
Vincristine, Dactinomycin, Cyclophosphamide (VAC) Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
VAC Alternating With Vincristine, Irinotecan (VI) Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Total Total of all reporting groups

Baseline Measures
   Vincristine, Dactinomycin, Cyclophosphamide (VAC)   VAC Alternating With Vincristine, Irinotecan (VI)   Total 
Overall Participants Analyzed 
[Units: Participants]
 239   242   481 
Age 
[Units: Months]
Mean (Standard Deviation)
 89.85  (73.39)   97.86  (82.66)   93.88  (78.21) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      109  45.6%      113  46.7%      222  46.2% 
Male      130  54.4%      129  53.3%      259  53.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      39  16.3%      28  11.6%      67  13.9% 
Not Hispanic or Latino      191  79.9%      204  84.3%      395  82.1% 
Unknown or Not Reported      9   3.8%      10   4.1%      19   4.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      2   0.8%      2   0.8%      4   0.8% 
Asian      7   2.9%      7   2.9%      14   2.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      37  15.5%      29  12.0%      66  13.7% 
White      165  69.0%      181  74.8%      346  71.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      28  11.7%      23   9.5%      51  10.6% 


  Outcome Measures
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1.  Primary:   Event Free Survival (EFS)   [ Time Frame: 4 years ]

2.  Primary:   Response Rate (RR)   [ Time Frame: Reporting Period 1 (Weeks 1 - 15) ]

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

4.  Secondary:   Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison   [ Time Frame: 4 years ]

5.  Secondary:   Local Failure   [ Time Frame: 2 years ]

6.  Secondary:   Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison   [ Time Frame: 4 years ]

7.  Secondary:   Incidence of Toxicity   [ Time Frame: Up to 15 weeks ]

8.  Secondary:   Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC   [ Time Frame: Up to 43 weeks ]

9.  Secondary:   Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 4   [ Time Frame: 4 years ]

10.  Secondary:   Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 15   [ Time Frame: 4 years ]

11.  Secondary:   Incidence of Toxicity Related to VI Treatment in Patients With UGT1A1 Genotype   [ Time Frame: Weeks 4-9 (the first exposure to VI) ]

12.  Secondary:   Toxicity With CYP2B6 Genotypes   [ Time Frame: During the study ]

13.  Secondary:   Toxicity With GSTA1 and CYP2C9 Genotypes   [ Time Frame: During the study ]

14.  Secondary:   Event Free Survival (EFS) by PAX Status   [ Time Frame: 4 years ]

15.  Secondary:   Incidence of Bladder Dysfunction   [ Time Frame: 3-6 years after enrollment ]


  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: NCT00354835     History of Changes
Other Study ID Numbers: ARST0531
NCI-2009-00427 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ARST0531 ( Other Identifier: Children's Oncology Group )
CDR0000487560 ( Other Identifier: ClinicalTrials.gov )
ARST0531 ( Other Identifier: Children's Oncology Group )
ARST0531 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
U10CA180886 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2006
First Posted: July 20, 2006
Results First Submitted: July 8, 2016
Results First Posted: July 25, 2017
Last Update Posted: July 25, 2017