Planning Margin Requirements for Pediatric Radiation Oncology

This study is currently recruiting participants.

Verified by St. Jude Children's Research Hospital, December 2008

First Received: June 23, 2008 Last Updated: December 2, 2008 History of Changes

Sponsored by:	St. Jude Children's Research Hospital
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00704613

Purpose

Currently the Planning Target Volume (PTV) and Planning Organs at Risk Volume (PRV) margins used for pediatric radiation treatments are empiric; therefore, a quantitative assessment of these margins is needed to improve treatment planning and delivery of the radiation therapy.

In this study, 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. A patient specific PTV and PRV margin schema will be developed based on the number of participants accrued.

Condition	Intervention
Pediatric Radiation	Radiation: Radiation

MedlinePlus related topics: Anesthesia Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Planning Margin Requirements for Pediatric Radiation Oncology: Pilot Study

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

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2008
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Head, Body, Extremity There will be 24 cohorts. The extremity group is broken into two cohorts. The cohorts are populated with the predicted patients accrual based on the patients treated with radiation from July 2006 through July 2007	Radiation: Radiation Radiation

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient will receive conformal 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704613

Contacts

Contact: Chris Beltran, PhD

1-866-278-5833

info@stjude.org

Locations

United States, Tennessee
St. Jude Children's Research Hospital	Recruiting
Memphis, Tennessee, United States, 38105
Contact: Chris Beltran, PhD 866-278-5833 info@stjude.org
Principal Investigator: Chris Beltran, PhD

Sponsors and Collaborators

St. Jude Children's Research Hospital

Investigators

Principal Investigator:

Chris Beltran, PhD

St. Jude Children's Research Hospital

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	St. Jude Children's Research Hospital ( Chris Beltran, PhD )
Study ID Numbers:	RTMRG1
Study First Received:	June 23, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00704613 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 06, 2009