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
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00704613     History of Changes
Other Study ID Numbers: RTMRG1
Study First Received: June 23, 2008
Last Updated: November 29, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 28, 2014