MeningiomaPhase 1/2NCT01117844
Proton Radiation For Meningiomas and Hemangiopericytomas
A Phase 1/2 study testing Proton Radiation in people with Meningioma and Hemangiopericytoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma, Hemangiopericytoma
- What is being tested?
- Proton Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2010to 31 Mar 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of WHO I-III meningiomas and hemangiopericytomas:
- WHO grade I :
- Tumor that are newly diagnosed and tumors that are incompletely excised
- Tumors that have recurred post resection
- WHO grade II:
- Any tumor, either completely or incompletely excised
Show all 13Show fewer
- Any recurrent tumor
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the Unviersity of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Feasibility and Phase II Study Using Proton Radiation For WHO Grade I-III Meningiomas and Hemangiopericytomas
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.
Read the detailed description
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:
- To assess acute side effects from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of meningiomas.
- To assess quality of life outcomes, with a focus on the rate of severe fatigue at 6 and 12 months from end of treatment.
- To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of meningiomas.
- To compare the dose distribution to tumor and surrounding normal structures using DVHs (Dose Volume Histograms) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes.
- To determine 1-yr local control and progression-free and overall survival using proton radiotherapy.
- Conditions
- Meningioma, Hemangiopericytoma
- Being tested
- Proton Radiation
- Medical subject headings
- Meningioma, Hemangiopericytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton RadiationRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Proton radiation | Experimental | Not described Receives: Radiation: Proton Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (5)
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.
Measured: 90 days
Fatigue - Brief Fatigue Inventory (BFI)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study start4 Feb 2010
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117844
- Sponsor's protocol ID
- UPCC 24309
- Status last verified
- Nov 2024
- First submitted
- 28 Apr 2010
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Phase II Study Using Proton Radiation For WHO Grade I-III Meningiomas and Hemangiopericytomas
- ClinicalTrials.gov ID
- NCT01117844
- Acronym / sponsor ID
- UPCC 24309
- Conditions
- Meningioma, Hemangiopericytoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 4 Feb 2010 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To assess acute side effects from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of meningiomas.
- To assess quality of life outcomes, with a focus on the rate of severe fatigue at 6 and 12 months from end of treatment.
- To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of meningiomas.
- To compare the dose distribution to tumor and surrounding normal structures using DVHs (Dose Volume Histograms) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes.
- To determine 1-yr local control and progression-free and overall survival using proton radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton radiation | Experimental | Radiation: Proton Radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed diagnosis of WHO I-III meningiomas and hemangiopericytomas:
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton RadiationProtons 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. | Radiation | Proton radiation |
Primary outcome
Feasibility and Safety
Time frame: 90 days
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
5 secondary outcomes
Late Toxicity
Time frame: 90 days
Fatigue - Brief Fatigue Inventory (BFI)
Time frame: 5 Years
Health Related Quality of Life
Time frame: 5 Years
Cumulative total dose (Gy) to normal brain tissue
Time frame: 8 Weeks
Progression free survival (PFS) and overall survival (OS)
Time frame: 5 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Proton Radiation in people with Meningioma and Hemangiopericytoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Safety (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.