Pediatric RadiationNCT00704613
Planning Margin Requirements for Pediatric Radiation Oncology
An observational study of Pediatric Radiation, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Radiation
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients will receive conformal or intensity-modulated radiation therapy (3D or IMRT).
- Research participant or legal guardian/representative gives written informed consent.
Who cannot join
- Unwillingness of research participant or legal guardian/representative to give written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Pediatric Radiation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 year
Secondary outcomes (1)
Estimate the number of patients required to develop a patient specific PTV and RTV margin recommendations.
Measured: 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric RadiationStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Merchant, DO, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704613
- Sponsor's protocol ID
- RTMRG1
- Status last verified
- Nov 2011
- First submitted
- 23 Jun 2008
- Last updated
- 1 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planning Margin Requirements for Pediatric Radiation Oncology
- ClinicalTrials.gov ID
- NCT00704613
- Acronym / sponsor ID
- RTMRG1
- Conditions
- Pediatric Radiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients will receive conformal or intensity-modulated radiation therapy (3D or IMRT).
- Research participant or legal guardian/representative gives written informed consent.
Key exclusion criteria (1 listed)
- Unwillingness of research participant or legal guardian/representative to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Estimate the number of patients required to develop a patient specific PTV and RTV margin recommendations.
Time frame: 4 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Merchant, DO, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Radiation, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2011.