Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

798 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-16

Study Completion Date

2021-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Registry for Analysis of Quality of Life, Normal Organ Toxicity and Survival of Pediatric Patients Treated With Proton Therapy

NCT02644993

Pediatric Cancer Patients

RECRUITING NA

Evaluation of Proton Therapy in Pediatric Cancer Patients

NCT03223766

Tumor

ACTIVE_NOT_RECRUITING

Individualized High Dose Methotrexate to Treat Cancer in Children Who Have a Significant Risk for Side Effects to Methotrexate

NCT02076997

Cancer

COMPLETED NA

Protocol For Collecting Data On Patients With Childhood Cancer

NCT00684580

Childhood Cancer

RECRUITING

Proton Radiation Therapy (RT) for the Treatment of Pediatric Rhabdomyosarcoma

NCT00592592

Rhabdomyosarcoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Data Collection

Intervention Type OTHER

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 Collection

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Data Collection

Information collected from follow-up visits post proton radiation therapy yearly or more often, and test results for at least 10-15 years.

Intervention Type OTHER

Dose Distribution Data Collection

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. All patients under the age of 18 who are treated with PBT will be eligible to participate in this trial.
2. Signed informed consent must be obtained from the patient or patient's representative prior to study enrollment.

Exclusion Criteria

1. Pregnant females are not eligible.
2. Patient or patient's parent or legal guardian representative is unable or unwilling to give informed consent.

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No