Clinical trial · Interventional
Proton Radiation Therapy for Gliomas
Phase II Study of Proton Radiation Therapy for Low Grade and Favorable Grade 3 Gliomas
- 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 the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects that patients would normally experience with conventional radiation therapy. In this research study the investigators are looking to determine if proton radiation with a reduced field size will be as effective in controlling tumor growth as photon therapy, while reducing the treatment-related side effects observed in patients with brain tumors.
Conditions
Conditions (3)
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 Glioma | Low Grade Glioma | ONTOLOGY_EXACT | 0.98 |
| WHO Grade 3 Glioma With 1p/19q Codeletion | — | UNRESOLVED | — |
| WHO Grade 3 Glioma With IDH1 Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton radiation therapy
- description
- Single arm study delivering fractionated proton therapy over 6 week (54-59.4 Gy(RBE))
- interventionNames
- Radiation: Proton radiation
Primary outcomes (1)
- measure
- Efficacy
- timeFrame
- 7 years
- description
- To assess progression free survival of this treatment program.
Secondary outcomes (2)
- measure
- Safety and Tolerability
- timeFrame
- 7 years
- description
- To assess the number of participants with late effects from radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed low-grade gliomas OR Grade III anaplastic glioma with either or both IDH1 mutation or 1p/19q codeletion * Subject must be indicated for radiation therapy * Life expectancy greater than 5 years * Willing to participate in rigorous neurocognitive evaluations at baseline and serially following treatment * Able to speak and comprehend English * Recovered from adverse events due to agents administered more than 4 weeks before entering study * Able to undergo MRI scans Exclusion Criteria: * Prior cranial radiation therapy * Chemotherapy within 4 weeks prior to entering study * Pregnant or breastfeeding * Known brain metastases * Baseline neurocognitive or emotional disorders * Uncontrolled intercurrent illness * History of a different malignancy unless disease-free for at least 5 years * HIV positive on antiretroviral therapy
References
Publications (0)
Data not yet available