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Planning Margin Requirements for Pediatric Radiation Oncology

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00704613
First Posted: June 25, 2008
Last Update Posted: December 1, 2011
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.
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
June 23, 2008
June 25, 2008
December 1, 2011
March 2008
July 2011   (Final data collection date for primary outcome measure)
Acquire data to develop setup margin (SM) portion of the planning target volume (PTV) margin for pediatric tumor sites according to age, localization technique, treatment position, and the use of general anesthesia. [ Time Frame: 4 year ]
To gather data in order to develop a model to quantify the setup margin (SM) portion of the planning target volume (PTV) margin for pediatric tumor sites according to age, localization technique, treatment position, and the use of general anesthesia. [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00704613 on ClinicalTrials.gov Archive Site
Estimate the number of patients required to develop a patient specific PTV and RTV margin recommendations. [ Time Frame: 4 year ]
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Planning Margin Requirements for Pediatric Radiation Oncology
Planning Margin Requirements for Pediatric Radiation Oncology
The planning target volume (PTV) and planning organ at risk volume (PRV) margins used for pediatric radiation therapy are empiric, and quantitative assessment of these margins is needed to improve therapy planning and delivery.
Data will be gathered to develop a model to quantify the setup margin (SM) portion of the planning target volume (PTV) margin for pediatric tumor sites according to age, localization technique, treatment position, and the use of general anesthesia. Patient specific PTV and PRV margin recommendations will be developed based on the number of participants.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
All patients receiving external beam radiation therapy at St. Jude Children's Research Hospital will be screened for participation on this research protocol based on the Inclusion Criteria.
Pediatric Radiation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
375
July 2011
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients will receive conformal or intensity-modulated radiation therapy (3D or IMRT).
  • Research participant or legal guardian/representative gives written informed consent.

Exclusion Criteria:

  • Unwillingness of research participant or legal guardian/representative to give written informed consent
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00704613
RTMRG1
No
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St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
Not Provided
Principal Investigator: Thomas Merchant, DO, PhD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
November 2011