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Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00085735
First Posted: June 16, 2004
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: February 22, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Untreated Childhood Medulloblastoma
Interventions: Drug: Cisplatin
Radiation: Craniospinal Irradiation
Drug: Cyclophosphamide
Radiation: Involved-Field Radiation Therapy
Other: Laboratory Biomarker Analysis
Drug: Lomustine
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Drug: Vincristine Sulfate

  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
Participants 3-21 years of age were recruited at Children's Oncology Group institutions worldwide and at sites affiliated with the Dutch Childhood Oncology Group. The first patient was enrolled on April 30, 2004 and the last patient was enrolled on January 6, 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomized to receive a smaller volume boost (radiation to tumor bed)(IFRT) or standard volume boost (radiation to the entire posterior fossa) (PFRT).Patients 3-7 years of age were also randomized to receive reduced-dose craniospinal radiation (LDCSI) or standard-dose craniospinal radiation (SDCSI).Patients 8 and older received SDCSI.

Reporting Groups
  Description
Arm I (3-7 Yrs of Age, LDCSI, IFRT) Patients 3-7 years of age, LDCSI, IFRT
Arm II (3-7 Yrs of Age, LDCSI, PFRT) Patients 3-7 years of age, LDCSI, PFRT
Arm III (3-7 Yrs of Age, SDCSI, IFRT) Patients 3-7 years of age, SDCSI, IFRT
Arm IV (3-7 Yrs of Age, SDCSI, PFRT) Patients 3-7 years of age, SDCSI, PFRT
Arm V (8-21 Yrs of Age, SDCSI, IFRT) Patients 8-21 years of age, SDCSI, IFRT
Arm VI (8-21 Yrs of Age, SDCSI, PFRT) Patients 8-21 yrs of age, SDCSI, PFRT

Participant Flow:   Overall Study
    Arm I (3-7 Yrs of Age, LDCSI, IFRT)   Arm II (3-7 Yrs of Age, LDCSI, PFRT)   Arm III (3-7 Yrs of Age, SDCSI, IFRT)   Arm IV (3-7 Yrs of Age, SDCSI, PFRT)   Arm V (8-21 Yrs of Age, SDCSI, IFRT)   Arm VI (8-21 Yrs of Age, SDCSI, PFRT)
STARTED   64   64   63   65   147   146 
COMPLETED   52   54   46   46   105   115 
NOT COMPLETED   12   10   17   19   42   31 
Adverse Event                1                0                0                0                0                0 
Lack of Efficacy                2                4                6                3                4                3 
Lost to Follow-up                0                1                0                0                1                0 
Physician Decision                2                3                2                3                11                8 
Protocol Violation                1                0                0                0                0                0 
Withdrawal by Subject                1                0                4                5                7                8 
Patient ineligible                1                0                3                7                17                8 
Excess residual disease                2                2                1                1                1                4 
Reason not documented                1                0                1                0                1                0 
Pt transferred to inst w/out study open                1                0                0                0                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.
Only eligible patients are included in each of the 6 groups for baseline characteristics.

Reporting Groups
  Description
Arm I (3-7 Years of Age, LDCSI, IFRT) Eligible patients 3-7 yrs of age, LDCSI, IFRT
Arm II (3-7 Years of Age, LDCSI, PFRT) Eligible patients 3-7 yrs of age, LDCSI, PFRT
Arm III (3-7 Years of Age, SDCSI, IFRT) Eligible patients 3-7 yrs of age, SDCSI, IFRT
Arm IV (3-7 Years of Age, SDCSI, PFRT) Eligible patients 3-7 yrs of age, SDCSI, PFRT
Arm V (8-21 Years of Age, SDCSI, IFRT) Eligible patients 8-21 yrs of age, SDCSI, IFRT
Arm VI (8-21 Years of Age, SDCSI, PFRT) Eligible patients 8-21 yrs of age, SDCSI, PFRT
Total Total of all reporting groups

Baseline Measures
   Arm I (3-7 Years of Age, LDCSI, IFRT)   Arm II (3-7 Years of Age, LDCSI, PFRT)   Arm III (3-7 Years of Age, SDCSI, IFRT)   Arm IV (3-7 Years of Age, SDCSI, PFRT)   Arm V (8-21 Years of Age, SDCSI, IFRT)   Arm VI (8-21 Years of Age, SDCSI, PFRT)   Total 
Overall Participants Analyzed 
[Units: Participants]
 63   64   60   58   130   138   513 
Age 
[Units: Participants]
Count of Participants
             
<=18 years      63 100.0%      64 100.0%      60 100.0%      58 100.0%      120  92.3%      128  92.8%      493  96.1% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      10   7.7%      10   7.2%      20   3.9% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Median (Full Range)
 5.9 
 (3.2 to 7.8) 
 5.9 
 (3.3 to 7.9) 
 5.9 
 (3.0 to 8.0) 
 5.4 
 (3.1 to 7.7) 
 12.4 
 (8.0 to 19.8) 
 11.8 
 (8 to 21.8) 
 8.3 
 (3.0 to 21.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      16  25.4%      20  31.3%      20  33.3%      24  41.4%      53  40.8%      51  37.0%      184  35.9% 
Male      47  74.6%      44  68.8%      40  66.7%      34  58.6%      77  59.2%      87  63.0%      329  64.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
             
Hispanic or Latino      10  15.9%      18  28.1%      8  13.3%      9  15.5%      19  14.6%      23  16.7%      87  17.0% 
Not Hispanic or Latino      51  81.0%      44  68.8%      50  83.3%      46  79.3%      110  84.6%      109  79.0%      410  79.9% 
Unknown or Not Reported      2   3.2%      2   3.1%      2   3.3%      3   5.2%      1   0.8%      6   4.3%      16   3.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
             
American Indian or Alaska Native      0   0.0%      0   0.0%      1   1.7%      0   0.0%      1   0.8%      0   0.0%      2   0.4% 
Asian      0   0.0%      0   0.0%      2   3.3%      2   3.4%      4   3.1%      2   1.4%      10   1.9% 
Native Hawaiian or Other Pacific Islander      1   1.6%      1   1.6%      1   1.7%      2   3.4%      0   0.0%      0   0.0%      5   1.0% 
Black or African American      5   7.9%      6   9.4%      5   8.3%      3   5.2%      13  10.0%      9   6.5%      41   8.0% 
White      50  79.4%      48  75.0%      46  76.7%      48  82.8%      108  83.1%      120  87.0%      420  81.9% 
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      7  11.1%      9  14.1%      5   8.3%      3   5.2%      4   3.1%      7   5.1%      35   6.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Event-free Survival (EFS)   [ Time Frame: 3 years ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: 3 years ]

3.  Secondary:   Local Posterior Fossa (LPF) Failure Rate   [ Time Frame: 3 years ]

4.  Secondary:   Non-local Posterior Fossa (NLPF) Failure Rate   [ Time Frame: 3 years ]

5.  Secondary:   Non-posterior Fossa (NPF) Failure Rate   [ Time Frame: 3 years ]

6.  Secondary:   Post-treatment Grade 3+ Hearing Loss as Measured by CTCAE v4   [ Time Frame: Up to 1 year after the end of treatment ]

7.  Secondary:   Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE Version 4   [ Time Frame: 1 year after end of treatment ]

8.  Secondary:   Post-treatment Endocrine Function (Growth Hormone (GH) and Thyroid Stimulating Hormone (TSH) as Measured by Laboratory Assessment)   [ Time Frame: Up to 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) and Also the Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF)   [ Time Frame: Up to 6 years post-diagnosis ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Test at the Completion of Therapy.   [ Time Frame: After completion of therapy, an average of 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Secondary:   Time to Death From Any Cause / Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays   [ Time Frame: Assessed at 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Secondary:   Time to Recurrence, Progression or Death Due to Cancer / Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays   [ Time Frame: Assessed at 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Secondary:   Compliance Rates for All Eligible and Evaluable Patients Enrolled   [ Time Frame: Up to 6 years post-diagnosis ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Childrens's Oncology Group
phone: 626-447-0064
e-mail: resultsreporingcoordinator@childrensoncologygroup.org



Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00085735     History of Changes
Other Study ID Numbers: ACNS0331
NCI-2009-00335 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ACNS0331
CDR0000365506
ACNS0331 ( Other Identifier: Childrens Oncology Group )
ACNS0331 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: June 14, 2004
First Posted: June 16, 2004
Results First Submitted: February 22, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017