Planning Margin Requirements for Pediatric Radiation Oncology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00704613
First received: June 23, 2008
Last updated: November 29, 2011
Last verified: November 2011

June 23, 2008
November 29, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00704613
RTMRG1
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP