Pediatric CancerNCT01502150
Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics
An observational study of Pediatric Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to collect information on the side effects of proton therapy and the details of proton treatment plans so that researchers can develop a method to predict the risk of side effects and to improve the planning and delivery of proton treatment for patients in the future. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Data Collection and Dose Distribution Data Collection
- How many people
- 798 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2005to 1 Jun 2021
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric cancer patients receiving proton radiation therapy at MD Anderson Cancer Center in Houston, Texas
Who may be able to join
- All patients under the age of 18 who are treated with PBT will be eligible to participate in this trial.
- Signed informed consent must be obtained from the patient or patient's representative prior to study enrollment.
Who cannot join
- Pregnant females are not eligible.
- Patient or patient's parent or legal guardian representative is unable or unwilling to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to collect information on the side effects of proton therapy and the details of proton treatment plans so that researchers can develop a method to predict the risk of side effects and to improve the planning and delivery of proton treatment for patients in the future.
Read the detailed description
If you agree to take part in this study, researchers will gather information about your treatment and treatment outcomes and store it electronically in a database. By carefully evaluating the data about your treatment, researchers may improve proton treatment for patients in the future. There will be no change to your recommended standard of care and follow-up studies. The treatment information and follow-up information will be stored in a database. The information will then be available at a later date for researchers to study. The database will be stored on a secure information network, and only those people who are involved with this research and who have prior approval from the study doctor will have access to it.
Researchers will request information from the follow-up visits that you have as part of your standard of care yearly or more often and test results for at least 10-15 years. The tests may be performed at other clinics, but MD Anderson researchers will request that the results be sent to them at MD Anderson.
This is an investigational study. Proton radiotherapy is FDA approved. Researchers hope to enroll all children who will be treated with proton radiotherapy at MD Anderson on this study so that as much information as possible will be gathered. Up to 1000 patients will be enrolled at MD Anderson.
- Conditions
- Pediatric Cancer
- Being tested
- Data Collection, Dose Distribution Data Collection
- Keywords
- Pediatric Cancer, Proton Radiation Therapy, Proton beam radiotherapy, PBT, Data Collection, Database, Acute and late normal tissue toxicities, Dosimetric data, Toxicity data
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
Information collected from follow-up visits post proton radiation therapy yearly or more often, and test results for at least 10-15 years.
Dose Distribution Data CollectionOther
Data collection of complete plan information, including dose distribution, beam configuration and images, computed tomography (CT) images acquired on multiple days and 4D CT's for respiratory correlated imaging.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Proton Therapy Patients | Data collection of MDACC patients under the age of 18 treated with proton radiotherapy. Proton dosimetry data collection, corresponding radiation dose distribution and imaging data in order to correlate normal tissue response with dose distribution. Receives: Other: Data Collection; Other: Dose Distribution Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection From Pediatric Patients Undergoing Proton Radiation Therapy
For each acute normal-tissue endpoint considered, analyses will be performed using the maximum toxicity score per patient within the 90-day follow-up. For each late normal-tissue endpoint considered, analyses will be performed using censored time-to-event data corresponding to specified levels of injury (e.g. time to a specific grade >= 2 late toxicity).
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study start16 Jun 2005
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 798 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnold dela Cruz Paulino, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502150
- Sponsor's protocol ID
- PCR05-0208
- Status last verified
- May 2019
- First submitted
- 21 Dec 2011
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics
- ClinicalTrials.gov ID
- NCT01502150
- Acronym / sponsor ID
- PCR05-0208
- Conditions
- Pediatric Cancer
- Keywords
- Pediatric Cancer, Proton Radiation Therapy, Proton beam radiotherapy, PBT, Data Collection, Database, Acute and late normal tissue toxicities, Dosimetric data
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 798 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 Jun 2005 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 30 Dec 2011 (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 goal of this research study is to collect information on the side effects of proton therapy and the details of proton treatment plans so that researchers can develop a method to predict the risk of side effects and to improve the planning and delivery of proton treatment for patients in the future.
Detailed description
If you agree to take part in this study, researchers will gather information about your treatment and treatment outcomes and store it electronically in a database. By carefully evaluating the data about your treatment, researchers may improve proton treatment for patients in the future. There will be no change to your recommended standard of care and follow-up studies. The treatment information and follow-up information will be stored in a database. The information will then be available at a later date for researchers to study. The database will be stored on a secure information network, and only those people who are involved with this research and who have prior approval from the study doctor will have access to it.
Researchers will request information from the follow-up visits that you have as part of your standard of care yearly or more often and test results for at least 10-15 years. The tests may be performed at other clinics, but MD Anderson researchers will request that the results be sent to them at MD Anderson.
This is an investigational study. Proton radiotherapy is FDA approved. Researchers hope to enroll all children who will be treated with proton radiotherapy at MD Anderson on this study so that as much information as possible will be gathered. Up to 1000 patients will be enrolled at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Proton Therapy Patients | – | Other: Data Collection, Other: Dose Distribution Data CollectionData collection of MDACC patients under the age of 18 treated with proton radiotherapy. Proton dosimetry data collection, corresponding radiation dose distribution and imaging data in order to correlate normal tissue response with dose distribution. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric cancer patients receiving proton radiation therapy at MD Anderson Cancer Center in Houston, Texas
Key inclusion criteria (2 listed)
- All patients under the age of 18 who are treated with PBT will be eligible to participate in this trial.
- Signed informed consent must be obtained from the patient or patient's representative prior to study enrollment.
Key exclusion criteria (2 listed)
- Pregnant females are not eligible.
- Patient or patient's parent or legal guardian representative is unable or unwilling to give 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data CollectionInformation collected from follow-up visits post proton radiation therapy yearly or more often, and test results for at least 10-15 years. | Other | Pediatric Proton Therapy Patients |
| Dose Distribution Data CollectionData collection of complete plan information, including dose distribution, beam configuration and images, computed tomography (CT) images acquired on multiple days and 4D CT's for respiratory correlated imaging. | Other | Pediatric Proton Therapy Patients |
Primary outcome
Data Collection From Pediatric Patients Undergoing Proton Radiation Therapy
Time frame: 15 years
For each acute normal-tissue endpoint considered, analyses will be performed using the maximum toxicity score per patient within the 90-day follow-up. For each late normal-tissue endpoint considered, analyses will be performed using censored time-to-event data corresponding to specified levels of injury (e.g. time to a specific grade >= 2 late toxicity).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Arnold dela Cruz Paulino, MD principal investigator
M.D. Anderson Cancer Center
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 Cancer, run by M.D. Anderson Cancer Center 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 2 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: status not confirmed, as of the sponsor's last update on 10 May 2019. 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?
Results are not available in the source record.
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?
Data Collection From Pediatric Patients Undergoing Proton Radiation Therapy (time frame: 15 years). 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 10 May 2019.