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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
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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.

Condition or disease
Pediatric Radiation

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
Actual Enrollment : 375 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Planning Margin Requirements for Pediatric Radiation Oncology
Study Start Date : March 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Estimate the number of patients required to develop a patient specific PTV and RTV margin recommendations. [ Time Frame: 4 year ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704613


Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Thomas Merchant, DO, PhD St. Jude Children's Research Hospital

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00704613     History of Changes
Other Study ID Numbers: RTMRG1
First Posted: June 25, 2008    Key Record Dates
Last Update Posted: December 1, 2011
Last Verified: November 2011