MeningiomaNCT02693990
A Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas
A study testing Intensity Modulated Proton Therapy (IMPT) in people with Meningioma and Brain Tumor, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This research study is studying radiation therapy as a possible treatment for meningioma or tumor on the lining of the brain. The study drug or intervention involved in this research study is Intensity Modulated Proton Therapy (IMPT) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma, Brain Tumor
- What is being tested?
- Intensity Modulated Proton Therapy (IMPT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2016to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participants must have either:
- histologically confirmed atypical meningioma, WHO grade II, Simpson grade 4-5 that has been either subtotally resected or biopsied.
- OR
- histologically confirmed malignant/anaplastic meningioma, WHO grade III with gross total resection.
- In the case of recurrent radiographically gross disease, pathologic diagnosis may be from time of original biopsy and/or surgery. Pathology should be reviewed and confirmed at the Participating Institution.
- Patients may or may not have neurofibromatosis type 1 or 2.
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- Age 18 years or older.
- ECOG performance status ≤ 2 (Karnofsky Performance Status ≥ 60, see Appendix A)
- The effects of proton radiation therapy on the developing human fetus are known to be teratogenic. For this reason, women of child-bearing potential and all men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of proton therapy.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants may not be receiving any other investigational agents.
- Participants may not have received prior cranial irradiation.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or lactating women are excluded from this study because radiation is known to have teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiation therapy, breastfeeding should be discontinued if the mother is treated with radiation therapy.
- Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas
This research study is studying radiation therapy as a possible treatment for meningioma or tumor on the lining of the brain. The study drug or intervention involved in this research study is Intensity Modulated Proton Therapy (IMPT)
Read the detailed description
This is a Phase I clinical trial. Researchers are trying to find out if using increased-dose intensity modulated proton therapy (IMPT) for treatment of Meningiomas will be more effective than the current treatment.
The intensity modulated part of IMPT allows for even better concentration of the radiation dose to the desired target and less dose to the surrounding normal tissues than even traditional passive scattering proton therapy can do. Proton beams can be regulated to stop within or shortly beyond treatment targets. Therefore there is little exposure of the normal tissue to radiation.
The FDA (the U.S. Food and Drug Administration) has not approved IMPT as a treatment for any disease.
- Conditions
- Meningioma, Brain Tumor
- Being tested
- Intensity Modulated Proton Therapy (IMPT)
- Keywords
- Tumor lining the brain, Meningioma, Brain Tumor
- Medical subject headings
- Meningioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity Modulated Proton Therapy (IMPT)Radiation
Radiation Therapy - Intensity Modulated Proton Therapy (IMPT)
| Study group | Role | What they receive |
|---|---|---|
| Grade II (Atypical) Meningiomas, STR | Experimental | Patient will be treated at the starting dose of Intensity Modulated Proton Therapy (IMPT) which is pre-determined. Receives: Radiation: Intensity Modulated Proton Therapy (IMPT) |
| Grade III (Malignant) Meningiomas, GTR | Experimental | Patient will be treated at a pre determined dose of Intensity Modulated Proton Therapy (IMPT) for the specific cohort. Receives: Radiation: Intensity Modulated Proton Therapy (IMPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Safety and Utility of Increased Dose IMPT: Dose-limiting toxicity (DLT) using NCI CTC 4.0
Establish a safe increased-dose of post-operative IMPT with SIB in treating each of two meningioma cohorts: grade II (atypical) with subtotal resection and grade III (malignant) with gross total resection. Dose-limiting toxicity (DLT) using NCI CTC 4.0 will be assessed from the start of protocol treatment. The dose-seeking plan for each meningioma cohort will follow a modified 3+3 design with the starting and reduced doses for CTV and GTV.
Measured: 2 years
Secondary outcomes (3)
The Absence of Progressive or Recurrent Disease
The duration of local tumor control will be measured from the start date of protocol treatment until the date of progressive or recurrent disease or censored at the date of last follow-up for patients still alive with stable disease. The rate of local failure will be estimated separately for each stratum based on the cumulative incidence, with death as a competing risk in the absence of progressive or recurrent disease.
Measured: 5 years
Overall Survival
- Overall survival (OS) will be measured from the start date of protocol treatment until the date of death due to any cause or censored at the date of last follow-up for patients still alive. The rate of OS will be estimated separately for each stratum using the Kaplan-Meier method.
Measured: 2 years
Calculate Linear Energy Transfer Using Computer Simulations Based on the Treatment Plan
- Linear energy transfer (LET) will be plotted against radiographic changes to assess the pattern of their correlation. Graphical methods and descriptive statistics will be used to determine if the relationship may be characterized by a formal model, possibly after data transformation. All strata will be pooled for the analyses of LET and the other physics endpoints, as they are functions of only the radiation physics, not histology or surgery.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
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 Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Helen A. Shih, MD, Massachusetts General Hospital
- Investigators
- Helen A Shih, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693990
- Sponsor's protocol ID
- 15-542
- Other IDs
- 2U19CA021239-36
- Status last verified
- Aug 2026
- First submitted
- 13 Jan 2016
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas
- ClinicalTrials.gov ID
- NCT02693990
- Acronym / sponsor ID
- 15-542
- Conditions
- Meningioma, Brain Tumor
- Keywords
- Tumor lining the brain, Meningioma, Brain Tumor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2016
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 29 Feb 2016 (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 research study is studying radiation therapy as a possible treatment for meningioma or tumor on the lining of the brain. The study drug or intervention involved in this research study is Intensity Modulated Proton Therapy (IMPT)
Detailed description
This is a Phase I clinical trial. Researchers are trying to find out if using increased-dose intensity modulated proton therapy (IMPT) for treatment of Meningiomas will be more effective than the current treatment.
The intensity modulated part of IMPT allows for even better concentration of the radiation dose to the desired target and less dose to the surrounding normal tissues than even traditional passive scattering proton therapy can do. Proton beams can be regulated to stop within or shortly beyond treatment targets. Therefore there is little exposure of the normal tissue to radiation.
The FDA (the U.S. Food and Drug Administration) has not approved IMPT as a treatment for any disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grade II (Atypical) Meningiomas, STR | Experimental | Radiation: Intensity Modulated Proton Therapy (IMPT)Patient will be treated at the starting dose of Intensity Modulated Proton Therapy (IMPT) which is pre-determined. |
| Grade III (Malignant) Meningiomas, GTR | Experimental | Radiation: Intensity Modulated Proton Therapy (IMPT)Patient will be treated at a pre determined dose of Intensity Modulated Proton Therapy (IMPT) for the specific cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must have either:
- OR
- histologically confirmed malignant/anaplastic meningioma, WHO grade III with gross total resection.
- In the case of recurrent radiographically gross disease, pathologic diagnosis may be from time of original biopsy and/or surgery. Pathology should be reviewed and confirmed at the Participating Institution.
- Patients may or may not have neurofibromatosis type 1 or 2.
Key exclusion criteria (5 listed)
- Participants may not be receiving any other investigational agents.
- Participants may not have received prior cranial irradiation.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or lactating women are excluded from this study because radiation is known to have teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiation therapy, breastfeeding should be discontinued if the mother is treated with radiation therapy.
- Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
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 |
|---|---|---|
| Intensity Modulated Proton Therapy (IMPT)Radiation Therapy - Intensity Modulated Proton Therapy (IMPT) | Radiation | Grade II (Atypical) Meningiomas, STR, Grade III (Malignant) Meningiomas, GTR |
Primary outcome
Assess Safety and Utility of Increased Dose IMPT: Dose-limiting toxicity (DLT) using NCI CTC 4.0
Time frame: 2 years
Establish a safe increased-dose of post-operative IMPT with SIB in treating each of two meningioma cohorts: grade II (atypical) with subtotal resection and grade III (malignant) with gross total resection. Dose-limiting toxicity (DLT) using NCI CTC 4.0 will be assessed from the start of protocol treatment. The dose-seeking plan for each meningioma cohort will follow a modified 3+3 design with the starting and reduced doses for CTV and GTV.
3 secondary outcomes
The Absence of Progressive or Recurrent Disease
Time frame: 5 years
Overall Survival
Time frame: 2 years
Calculate Linear Energy Transfer Using Computer Simulations Based on the Treatment Plan
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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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.
Helen A Shih, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensity Modulated Proton Therapy (IMPT) in people with Meningioma and Brain Tumor, run by Massachusetts General Hospital at 2 sites 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 10 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Assess Safety and Utility of Increased Dose IMPT: Dose-limiting toxicity (DLT) using NCI CTC 4.0 (time frame: 2 years). 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 24 Aug 2026.