Clinical trial · Interventional
Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas
Proton Radiation for Low Grade Gliomas
NCT01024907CI-TRIAL-00048769completedPhase 1 / Phase 2ClinicalTrials.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)
RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying the best way to give proton beam radiation therapy and to see how well it works in treating patients with low grade gliomas.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Brain Stem Glioma | Adult Brain Stem Glioma | ONTOLOGY_EXACT | 0.98 |
| Adult Brain Tumor | Adult Brain Neoplasm | ALIAS | 0.90 |
| Adult Diffuse Astrocytoma | Adult Diffuse Astrocytoma | ONTOLOGY_EXACT | 0.98 |
| Adult Ependymoma | Adult Ependymoma | ONTOLOGY_EXACT | 0.98 |
| Adult Grade II Meningioma | Adult Grade 2 Meningioma | ALIAS | 0.90 |
| Adult Melanocytic Lesion | — | UNRESOLVED | — |
| Adult Meningeal Hemangiopericytoma | Meningeal Solitary Fibrous Tumor | ALIAS | 0.85 |
| Adult Mixed Glioma | Adult Mixed Glioma | ONTOLOGY_EXACT | 0.98 |
| Adult Oligodendroglioma | Adult Oligodendroglioma | ONTOLOGY_EXACT |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| proton beam radiation therapy | Radiation | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Radiation: proton beam radiation therapy
- Procedure: quality-of-life assessment
- Other: questionnaire administration
Primary outcomes (2)
- measure
- Feasibility (phase I)
- measure
- Acute toxicity as assessed by NCI CTC version 3.0 (phases I and II)
- timeFrame
- 60 days (phase I) or 90 days (phase II) from completion of radiation therapy
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion * Patients with histologically confirmed diagnosis of low grade glioma of the CNS * Patients with WHO grade II; may be symptomatic; including patients who are being followed and have radiographic expression * Patients must have a Karnofsky Performance Status of \>= 60 * Patients must be able to provide informed consent * Patients must have adequate bone marrow function: 1. WBC \>= 4000/mm\^3 2. platelets \>= 100,000 mm\^3 * Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc); Hysterectomy or menopause must be clinically documented Exclusion * Patients who have had prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) * Patients with the following histologies: gliomatosis cerebrei, WHO III or IV gliomas * Patients who have had any prior Radiation treatment * Patients who have had any chemotherapy administered within 30 days of the planned radiation treatment start date * Pregnant women, women planning to become pregnant and women that are nursing * Patients who are actively being treated on any other therapeutic research study
References
Publications (1)
- DERIVEDMaquilan G, Grover S, Alonso-Basanta M, Lustig RA. Acute toxicity profile of patients with low-grade gliomas and meningiomas receiving proton therapy. Am J Clin Oncol. 2014 Oct;37(5):438-43. doi: 10.1097/COC.0b013e31827de86b. PMID 23388559