Planning Margin Requirements for Pediatric Radiation Oncology

Tracking Information
First Submitted Date	June 23, 2008
First Posted Date	June 25, 2008
Last Update Posted Date	December 1, 2011
Study Start Date	March 2008
Actual Primary Completion Date	July 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: November 29, 2011)	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 ]
Original Primary Outcome Measures; (submitted: June 23, 2008)	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 ]
Change History	Complete list of historical versions of study NCT00704613 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: November 29, 2011)	Estimate the number of patients required to develop a patient specific PTV and RTV margin recommendations. [ Time Frame: 4 year ]
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Planning Margin Requirements for Pediatric Radiation Oncology
Official Title	Planning Margin Requirements for Pediatric Radiation Oncology
Brief Summary	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.
Detailed Description	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.
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	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.
Condition	Pediatric Radiation
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: November 29, 2011)	375
Original Estimated Enrollment; (submitted: June 23, 2008)	200
Actual Study Completion Date	July 2011
Actual Primary Completion Date	July 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria	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
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00704613
Other Study ID Numbers	RTMRG1
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	St. Jude Children's Research Hospital
Study Sponsor	St. Jude Children's Research Hospital
Collaborators	Not Provided
Investigators	Principal Investigator: Thomas Merchant, DO, PhD St. Jude Children's Research Hospital
PRS Account	St. Jude Children's Research Hospital
Verification Date	November 2011