A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas

This study has been completed.
Sponsor:
Collaborator:
Pediatric Brain Tumor Consortium
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01118377
First received: April 15, 2010
Last updated: February 4, 2014
Last verified: February 2014
Results First Received: September 30, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Brainstem Glioma
Interventions: Drug: Capecitabine
Radiation: 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
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Reporting Groups
  Description
Capecitabine + Radiation Therapy Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.

Participant Flow:   Overall Study
    Capecitabine + Radiation Therapy  
STARTED     45  
COMPLETED     3  
NOT COMPLETED     42  
Did Not Receive Study Medication                 1  
Death                 38  
Failure to Return                 3  



  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.
Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the intent-to-treat population (34 participants from study NO21125 and 10 participants from study NO18517).

Reporting Groups
  Description
Capecitabine + Radiation Therapy Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.

Baseline Measures
    Capecitabine + Radiation Therapy  
Number of Participants  
[units: participants]
  44  
Age  
[units: years]
Mean ± Standard Deviation
  7.5  ± 3.69  
Gender  
[units: participants]
 
Female     22  
Male     22  



  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: Baseline to the end of the study (up to 20 weeks) ]

2.  Secondary:   Overall Survival   [ Time Frame: Baseline to the end of the study (up to 20 weeks) ]

3.  Secondary:   Percentage of Participants With a Tumor Response   [ Time Frame: Baseline to the end of the study (up to 20 weeks) ]


  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: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01118377     History of Changes
Other Study ID Numbers: NO21125, PBTC-030
Study First Received: April 15, 2010
Results First Received: September 30, 2013
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration