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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
  Purpose
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
Pediatric Radiation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Planning Margin Requirements for Pediatric Radiation Oncology

Further study details as provided by St. Jude Children's Research Hospital:

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 ]

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

Enrollment: 375
Study Start Date: March 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00704613     History of Changes
Other Study ID Numbers: RTMRG1
First Submitted: June 23, 2008
First Posted: June 25, 2008
Last Update Posted: December 1, 2011
Last Verified: November 2011