Clinical trial · Interventional
Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
NCT00681473CI-TRIAL-00026311completedN/AResults postedClinicalTrials.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)
In this research study, we are looking to study the side effects from the use of proton radiation in treating people with low-grade gliomas that are recommended radiation treatment. We expect response of the tumors to be the same with proton radiation as compared to standard 3D conformal radiation therapy, but also expect less side effects from radiation.
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 |
|---|---|---|---|
| Low Grade Gliomas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton Radiation Therapy
- description
- Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
- interventionNames
- Radiation: Proton Radiation Therapy
Primary outcomes (1)
- measure
- Number of Participants With Late Effects > 3 Months Post RT
- timeFrame
- 5 years
Secondary outcomes (2)
- measure
- Percentage of Participants With Progression Free Survival
- timeFrame
- At 1, 3, and 5 years
- description
- Clinical and/or radiographic assessments Percentages were estimated by Kaplan Meier
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed low-grade gliomas, WHO classification II/IV or equivalent low grade histology, including protoplasmic, fibrillary, gemistocytic astrocytomas, and mixed variants such as oligoastrocytomas * Must have at least one of: (1) progressive or recurrent disease as defined by imaging, (2) persistence or progression of debilitating neurological symptoms, or (3) at risk of early progression as defined by either (a) age of 40 or older or (b) MIB-1 of 3% or greater * KPS of 70 or greater * 18 years of age or older * Surgical and medical/chemotherapeutic interventions are per physician's discretion and are acceptable * Must be able to speak and comprehend English Exclusion Criteria: * Other baseline neurocognitive or emotional disorders or deficits, including but not limited to head injury, CVA, TIA, or other cerebral insults with residual neuropsychiatric deficits, psychiatric disorders, learning disabilities, HIV positivity or other medical conditions at high risk of causing neurocognitive decline or emotional instability * Prior history of cranial irradiation * Pregnancy at the time of radiation treatment * Unable to undergo MRI scans (e.g., embedded ferromagnetic metal or pacemakers) * Comorbid illness or reason to suggest a life expectancy of less than 5 years
References
Publications (0)
Data not yet available
No reference posted for this study.