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Trial record 1 of 1 for:    ARST0331
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Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma

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ClinicalTrials.gov Identifier: NCT00075582
Recruitment Status : Active, not recruiting
First Posted : January 12, 2004
Results First Posted : April 11, 2014
Last Update Posted : November 4, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Rhabdomyosarcoma
Embryonal Childhood Rhabdomyosarcoma
Embryonal-botryoid Childhood Rhabdomyosarcoma
Previously Untreated Childhood Rhabdomyosarcoma
Interventions: Procedure: conventional surgery
Drug: dactinomycin
Drug: cyclophosphamide
Drug: vincristine sulfate
Radiation: radiation therapy

  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
Regimen I (Chemotherapy, Radiotherapy)

Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)

dactinomycin: Given IV

cyclophosphamide: Given IV

vincristine sulfate: Given IV

radiation therapy: Undergo radiotherapy

Regimen II (Chemotherapy, Radiotherapy, Surgery)

Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).

conventional surgery: Some patients may undergo second-look surgery

dactinomycin: Given IV

cyclophosphamide: Given IV

vincristine sulfate: Given IV

radiation therapy: Undergo radiotherapy


Participant Flow:   Overall Study
    Regimen I (Chemotherapy, Radiotherapy)   Regimen II (Chemotherapy, Radiotherapy, Surgery)
STARTED   305   85 
COMPLETED   255   50 
NOT COMPLETED   50   35 
Adverse Event                3                1 
Lack of Efficacy                4                8 
Physician Decision                5                8 
Withdrawal by Subject                2                2 
Ineligible for study                36                16 



  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
Regimen I (Chemotherapy, Radiotherapy)

Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)

dactinomycin: Given IV

cyclophosphamide: Given IV

vincristine sulfate: Given IV

radiation therapy: Undergo radiotherapy

Regimen II (Chemotherapy, Radiotherapy, Surgery)

Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).

conventional surgery: Some patients may undergo second-look surgery

dactinomycin: Given IV

cyclophosphamide: Given IV

vincristine sulfate: Given IV

radiation therapy: Undergo radiotherapy

Total Total of all reporting groups

Baseline Measures
   Regimen I (Chemotherapy, Radiotherapy)   Regimen II (Chemotherapy, Radiotherapy, Surgery)   Total 
Overall Participants Analyzed 
[Units: Participants]
 305   85   390 
Age 
[Units: Years]
Mean (Standard Deviation)
 7.69  (5.81)   5.02  (6.78)   7.11  (6.13) 
Gender 
[Units: Participants]
Count of Participants
     
Female      88  28.9%      55  64.7%      143  36.7% 
Male      217  71.1%      30  35.3%      247  63.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      2   0.7%      2   2.4%      4   1.0% 
Asian      9   3.0%      2   2.4%      11   2.8% 
Native Hawaiian or Other Pacific Islander      1   0.3%      0   0.0%      1   0.3% 
Black or African American      39  12.8%      9  10.6%      48  12.3% 
White      228  74.8%      65  76.5%      293  75.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      26   8.5%      7   8.2%      33   8.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      38  12.5%      9  10.6%      47  12.1% 
Not Hispanic or Latino      255  83.6%      71  83.5%      326  83.6% 
Unknown or Not Reported      12   3.9%      5   5.9%      17   4.4% 
Region of Enrollment 
[Units: Participants]
     
United States   269   77   346 
Canada   21   5   26 
Australia   7   3   10 
Netherlands   2   0   2 
New Zealand   1   0   1 
Puerto Rico   2   0   2 
Switzerland   3   0   3 


  Outcome Measures

1.  Primary:   Estimated Percentage of Patients Failure Free at 5 Years (95% Confidence Interval)   [ Time Frame: 5 years from study enrollment ]

Measure Type Primary
Measure Title Estimated Percentage of Patients Failure Free at 5 Years (95% Confidence Interval)
Measure Description Failure-free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.
Time Frame 5 years from study enrollment  

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.
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.

Reporting Groups
  Description
Regimen I (Chemotherapy, Radiotherapy)

Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)

dactinomycin: Given IV

cyclophosphamide: Given IV

vincristine sulfate: Given IV

radiation therapy: Undergo radiotherapy

Regimen II (Chemotherapy, Radiotherapy, Surgery)

Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).

conventional surgery: Some patients may undergo second-look surgery

dactinomycin: Given IV

cyclophosphamide: Given IV

vincristine sulfate: Given IV

radiation therapy: Undergo radiotherapy


Measured Values
   Regimen I (Chemotherapy, Radiotherapy)   Regimen II (Chemotherapy, Radiotherapy, Surgery) 
Participants Analyzed   269   69 
Estimated Percentage of Patients Failure Free at 5 Years (95% Confidence Interval) 
[Units: Estimated percentage of participants]
Number (95% Confidence Interval)
 87 
 (82 to 91) 
 67 
 (52 to 79) 

No statistical analysis provided for Estimated Percentage of Patients Failure Free at 5 Years (95% Confidence Interval)



2.  Primary:   Estimated Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Group I or Stage 2 Group II Disease Treated With Regimen 1 Failure-free at 5 Years   [ Time Frame: 5 years from study enrollment ]

Measure Type Primary
Measure Title Estimated Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Group I or Stage 2 Group II Disease Treated With Regimen 1 Failure-free at 5 Years
Measure Description Failure-free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.
Time Frame 5 years from study enrollment  

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.
All eligible patients among this subset of regimen 1 patients were included in this outcome measure restricted to regimen 1 patients (there were 36 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.

Reporting Groups
  Description
Regimen I (Chemotherapy, Radiotherapy)

Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)

dactinomycin: Given IV

cyclophosphamide: Given IV

vincristine sulfate: Given IV

radiation therapy: Undergo radiotherapy


Measured Values
   Regimen I (Chemotherapy, Radiotherapy) 
Participants Analyzed   30 
Estimated Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Group I or Stage 2 Group II Disease Treated With Regimen 1 Failure-free at 5 Years 
[Units: Estimated percentage of participants]
Number (95% Confidence Interval)
 90 
 (72 to 97) 

No statistical analysis provided for Estimated Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Group I or Stage 2 Group II Disease Treated With Regimen 1 Failure-free at 5 Years



3.  Primary:   Estimated Percentage of Patients With Low-risk Rhabdomyosarcoma Treated With Regimen 2 Therapy Failure Free at 5 Years (95% Confidence Interval).   [ Time Frame: 5 years from study enrollment ]

Measure Type Primary
Measure Title Estimated Percentage of Patients With Low-risk Rhabdomyosarcoma Treated With Regimen 2 Therapy Failure Free at 5 Years (95% Confidence Interval).
Measure Description Failure free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.
Time Frame 5 years from study enrollment  

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.
All eligible patients among this subset of regimen 2 patients were included in this outcome measure to regimen 2 patients (there were 16 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.

Reporting Groups
  Description
Regimen II (Chemotherapy, Radiotherapy, Surgery)

Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).

conventional surgery: Some patients may undergo second-look surgery

dactinomycin: Given IV

cyclophosphamide: Given IV

vincristine sulfate: Given IV

radiation therapy: Undergo radiotherapy


Measured Values
   Regimen II (Chemotherapy, Radiotherapy, Surgery) 
Participants Analyzed   69 
Estimated Percentage of Patients With Low-risk Rhabdomyosarcoma Treated With Regimen 2 Therapy Failure Free at 5 Years (95% Confidence Interval). 
[Units: Estimated percentage of participants]
Number (95% Confidence Interval)
 67 
 (52 to 79) 

No statistical analysis provided for Estimated Percentage of Patients With Low-risk Rhabdomyosarcoma Treated With Regimen 2 Therapy Failure Free at 5 Years (95% Confidence Interval).



4.  Secondary:   Rate of Local Failure for Patients Who Receive Reduced Doses of Radiation Therapy   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Rate of Second-look Surgery and the Proportion of Patients Who Are Tumor-free or With Microscopic Tumor Only Following Second-look Surgeries   [ Time Frame: At 13 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Rate of Local Failure for Patients With Clinical Group III Disease When the Radiotherapy Dose is Reduced After Second-look Surgical Resection.   [ Time Frame: Up to 20 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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

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


Publications:
Woolson RF (1981) Rank-tests and a one-sample log-rank test for comparing observed survival-data to a standard population. Biometrics 37: 687-696.


Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00075582     History of Changes
Other Study ID Numbers: ARST0331
NCI-2009-00425 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ARST0331 ( Other Identifier: Children's Oncology Group )
CDR0000347078 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: January 9, 2004
First Posted: January 12, 2004
Results First Submitted: December 16, 2013
Results First Posted: April 11, 2014
Last Update Posted: November 4, 2016