Clinical trial · Observational
Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics
NCT01502150CI-TRIAL-00038555unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Data Collection | Other | — | UNRESOLVED |
| Dose Distribution Data Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pediatric Proton Therapy Patients
- description
- 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.
- interventionNames
- Other: Data Collection
- Other: Dose Distribution Data Collection
Primary outcomes (1)
- measure
- Data Collection From Pediatric Patients Undergoing Proton Radiation Therapy
- timeFrame
- 15 years
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.