Clinical trial · Interventional
Proton Radiation For Meningiomas and Hemangiopericytomas
Feasibility and Phase II Study Using Proton Radiation For WHO Grade I-III Meningiomas and Hemangiopericytomas
- 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)
This is a Feasibility/Phase II study for patients with a diagnosis of WHO Grade I - III Meningioma \& Hemangiopericytoma brain cancer to be given standard dose Proton radiotherapy. The study will be performed in two phases: first, feasibility with an enrollment of 12 patients and then Phase Page 8 of 20 II, with an enrollment of an additional 38 patients. All patients will also be given quality of life (QOL) instruments pretreatment, weekly during treatment, then q 3 months for year 1 post treatment, q6 months year 2 \& 3 and yearly for year 4 \& 5. Comparisons will be made between the enrolled subjects receiving proton therapy and the known literature on photon radiation. See section 2 for full objectives. The second phase will begin no earlier than 60 days after the last patient in the initial phase has completed treatment and once safety and feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemangiopericytoma | Hemangiopericytoma | ONTOLOGY_EXACT | 0.90 |
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton radiation
- interventionNames
- Radiation: Proton Radiation
Primary outcomes (1)
- measure
- Feasibility and Safety
- timeFrame
- 90 days
- description
- For proton to deemed feasible, no greater than 10% of patients should experience a) Patient cannot be given treatment because anatomy is such that a dosimetically satisfactory treatment plan cannot be devised, b) Patient is unable to tolerate 20% of treatments using proton therapy, and c) patient is unable to complete all treatments within 7 days of estimated date of treatment completion
Secondary outcomes (5)
- measure
- Late Toxicity
- timeFrame
- 90 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed diagnosis of WHO I-III meningiomas and hemangiopericytomas:
1. WHO grade I :
* Tumor that are newly diagnosed and tumors that are incompletely excised
* Tumors that have recurred post resection
2. WHO grade II:
* Any tumor, either completely or incompletely excised
* Any recurrent tumor
3. WHO grade III and hemangiopericytoma:
* Any tumor, either completely or incompletely excised
* Any recurrent tumor
* Patients must have a Karnofsky Performance Status of 60. Age greater than 18 years Patients must be able to provide informed consent.
* Adequate bone marrow function: WBC greater than 4000/mm3, platelets greater than 100,000 mm3.
* 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 Criteria:
* Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma).
* Pregnant women, women planning to become pregnant and women that are nursing. Actively being treated on any other therapeutic research study.
* Prior radiation to the brain.References
Publications (0)
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