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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.
Primary Objectives:
The primary objectives of this study are feasibility and safety. The study will be deemed infeasible if greater than 10% of pts experience one of the following:
Patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised.
(95% of target volume covered by 95% of the dose)
Patient is unable to tolerate 20% of treatments (for any reason unable to set patient up within acceptable limits of tolerance, patient unable to tolerate treatment position or immobilization for duration of treatment) using proton radiotherapy (up to 80% of treatments could be delivered using photons).
Patient is unable to complete all of his/her treatments within 7 days of estimated date of treatment completion or requires a treatment break greater than 5 days. Toxicity will be deemed unacceptable if greater than 20% of patients experience acute toxicity, as defined in Section 7.12.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton radiation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Radiation | Radiation | Protons have been demonstrated for medulloblastoma and prostate cancer, and comparative treatment planning using protons versus photons have shown a clear advantage to protons in terms of dose distribution. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Safety | 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 | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Late Toxicity | Late toxicity is defined as any grade 3 or higher toxicity, excluding seizures, observed later than 90 days from start of radiation therapy. | 90 days |
| Fatigue - Brief Fatigue Inventory (BFI) |
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Inclusion Criteria:
Histologically confirmed diagnosis of WHO I-III meningiomas and hemangiopericytomas:
WHO grade I :
WHO grade II:
WHO grade III and hemangiopericytoma:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the Unviersity of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 4, 2024 | |
| Reset | Dec 26, 2024 | |
| Release | Jan 3, 2025 | |
| Reset | Jan 27, 2025 | |
| Release | Apr 25, 2025 | |
| Reset | May 9, 2025 | |
| Release | Jun 9, 2025 | |
| Reset | Jun 25, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 4, 2024 | Dec 26, 2024 | |||
| Jan 3, 2025 |
| ID | Term |
|---|---|
| D008579 | Meningioma |
| D006393 | Hemangiopericytoma |
| ID | Term |
|---|---|
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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Fatigue will be scored by the Brief Fatigue Inventory (BFI), a validated instrument, which will be evaluated at the following time points: Pre-radiation, weekly during treatment, at 3, 6, 9, 12 months post-radiation and then every 6 months. It is expected that BFI score will increase (as fatigue worsens) in the first 6-9 months post-radiation and then the BFI score will decrease (as fatigue improves) at 12-24 months post-radiation. Proton radiotherapy is expected to improve fatigue as compared to photon radiotherapy.
| 5 Years |
| Health Related Quality of Life | Health Related Quality of Life will be followed using the following: EQ-5D European Quality of Life Index, Fact-G Functional Assessment of Cancer Therapy-General (FACT-G), and Fact-BR Functional Assessment of Cancer Therapy-Brain. Fact-BR will be evaluated at the same time points as the BFI. EQ-5D and Fact-G will be evaluated at pre-radiation, at 3, 6, 9, 12 months postradiation and then every 6 months. | 5 Years |
| Cumulative total dose (Gy) to normal brain tissue | Cumulative total dose (Gy) to normal brain tissue will be estimated based on dosimetry plans for both proton and photon. Proton radiotherapy is expected to decrease exposure to normal brain tissues. | 8 Weeks |
| Progression free survival (PFS) and overall survival (OS) | PFS and OS are defined as the time from start of radiotherapy to first documented progression (event for PFS), death due to any cause or last patient contact alive. | 5 Years |
| Jan 27, 2025 |
| Apr 25, 2025 | May 9, 2025 |
| Jun 9, 2025 | Jun 25, 2025 |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |