Planning Margin Requirements for Pediatric Radiation Oncology
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ClinicalTrials.gov Identifier: NCT00704613 |
Recruitment Status
:
Completed
First Posted
: June 25, 2008
Last Update Posted
: December 1, 2011
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Sponsor:
St. Jude Children's Research Hospital
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
Tracking Information | ||||
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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 |
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 |
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 |
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 |
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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. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
375 | |||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | St. Jude Children's Research Hospital | |||
Verification Date | November 2011 |