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Single-Fraction Compared With Multiple-Fraction Therapy in Treating Patients With Previously Irradiated Painful Bone Metastases

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Trans-Tasman Radiation Oncology Group (TROG)
Cancer Research UK
Dutch Bone Metastasis Study Group
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )
ClinicalTrials.gov Identifier:
NCT00080912
First received: April 7, 2004
Last updated: February 11, 2015
Last verified: February 2015
Results First Received: February 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Metastatic Cancer
Pain
Intervention: 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
Single-fraction

Patients receive single-fraction radiotherapy (8 Gy) on day 1.

radiation therapy: Given in a single fraction or multiple fractions

Multiple-fraction

Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.

radiation therapy: Given in a single fraction or multiple fractions


Participant Flow:   Overall Study
    Single-fraction   Multiple-fraction
STARTED   425   425 
COMPLETED   425   425 
NOT COMPLETED   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
Single-fraction

Patients receive single-fraction radiotherapy (8 Gy) on day 1.

radiation therapy: Given in a single fraction or multiple fractions

Multiple-fraction

Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.

radiation therapy: Given in a single fraction or multiple fractions

Total Total of all reporting groups

Baseline Measures
   Single-fraction   Multiple-fraction   Total 
Overall Participants Analyzed 
[Units: Participants]
 424   423   847 
Age 
[Units: Years]
Median (Full Range)
 64.6 
 (18.4 to 94.5) 
 65.3 
 (32.0 to 93.0) 
 65.1 
 (18.4 to 94.5) 
Gender 
[Units: Participants]
     
Female   181   167   348 
Male   243   256   499 


  Outcome Measures

1.  Primary:   Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment   [ Time Frame: 2 months ]


  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 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: Dr. Bingshu Chen
Organization: NCIC Clinical Trials Group
phone: 613-533-6000 ext 77703
e-mail: bechen@ctg.queensu.ca


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Canadian Cancer Trials Group ( NCIC Clinical Trials Group )
ClinicalTrials.gov Identifier: NCT00080912     History of Changes
Obsolete Identifiers: NCT00797173
Other Study ID Numbers: SC20
CAN-NCIC-SC20
RTOG-0433
TROG-03.08
CDR0000357423 ( Other Identifier: PDQ )
Study First Received: April 7, 2004
Results First Received: February 11, 2015
Last Updated: February 11, 2015
Health Authority: Canada: NCIC Clinical Trials Group