Low Grade GliomaNCT01358058
Proton Radiation Therapy for Gliomas
A study testing Proton radiation in people with Low Grade Glioma and WHO Grade 3 Glioma With IDH1 Mutation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this research study the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal tissue from exposure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Grade Glioma, WHO Grade 3 Glioma With IDH1 Mutation, WHO Grade 3 Glioma With 1p/19q Codeletion
- 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
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Nov 2027
- 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
- Histologically confirmed low-grade gliomas OR Grade III anaplastic glioma with either or both IDH1 mutation or 1p/19q codeletion
- Subject must be indicated for radiation therapy
- Life expectancy greater than 5 years
- Willing to participate in rigorous neurocognitive evaluations at baseline and serially following treatment
- Able to speak and comprehend English
- Recovered from adverse events due to agents administered more than 4 weeks before entering study
- Able to undergo MRI scans
Who cannot join
- Prior cranial radiation therapy
- Chemotherapy within 4 weeks prior to entering study
- Pregnant or breastfeeding
- Known brain metastases
- Baseline neurocognitive or emotional disorders
- Uncontrolled intercurrent illness
- History of a different malignancy unless disease-free for at least 5 years
- HIV positive on antiretroviral therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Phase II Study of Proton Radiation Therapy for Low Grade and Favorable Grade 3 Gliomas
In this research study the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects that patients would normally experience with conventional radiation therapy.
In this research study the investigators are looking to determine if proton radiation with a reduced field size will be as effective in controlling tumor growth as photon therapy, while reducing the treatment-related side effects observed in patients with brain tumors.
Read the detailed description
Proton radiation will be delivered daily for approximately 6 weeks. Subjects will be assessed weekly for side effects. Each visit will take about 15 minutes.
Subjects will have follow-up visits at 3, 6, 12, 24, 36, 48, 60, 72, and 84 months after their last proton radiation treatment. They will receive a physical exam, MRI, have blood tests (about 4 teaspoons) and answer questionnaires regarding medical history, quality of life, and emotional well-being. Subjects will also receive a neurocognitive exam annually.
- Conditions
- Low Grade Glioma, WHO Grade 3 Glioma With IDH1 Mutation, WHO Grade 3 Glioma With 1p/19q Codeletion
- Being tested
- Proton radiation
- Keywords
- Brain tumors, Radiation, Proton, Gliomas
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton radiationRadiation
Total dose of 54-59.4 Gy(RBE) at 1.8 Gy(RBE) per daily fraction delivered 5 days per week on weekdays for 6-6.5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Proton radiation therapy | Experimental | Single arm study delivering fractionated proton therapy over 6 week (54-59.4 Gy(RBE)) Receives: Radiation: Proton radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
To assess progression free survival of this treatment program.
Measured: 7 years
Secondary outcomes (2)
Safety and Tolerability
To assess the number of participants with late effects from radiation therapy
Measured: 7 years
Overall survival
To assess overall survival of this treatment program.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade GliomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 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
- NCT01358058
- Sponsor's protocol ID
- 10-439
- Status last verified
- Dec 2025
- First submitted
- 17 May 2011
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Proton Radiation Therapy for Low Grade and Favorable Grade 3 Gliomas
- ClinicalTrials.gov ID
- NCT01358058
- Acronym / sponsor ID
- 10-439
- Conditions
- Low Grade Glioma, WHO Grade 3 Glioma With IDH1 Mutation, WHO Grade 3 Glioma With 1p/19q Codeletion
- Keywords
- Brain tumors, Radiation, Proton, Gliomas
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2011
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 May 2011 (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.
In this research study the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects that patients would normally experience with conventional radiation therapy.
In this research study the investigators are looking to determine if proton radiation with a reduced field size will be as effective in controlling tumor growth as photon therapy, while reducing the treatment-related side effects observed in patients with brain tumors.
Detailed description
Proton radiation will be delivered daily for approximately 6 weeks. Subjects will be assessed weekly for side effects. Each visit will take about 15 minutes.
Subjects will have follow-up visits at 3, 6, 12, 24, 36, 48, 60, 72, and 84 months after their last proton radiation treatment. They will receive a physical exam, MRI, have blood tests (about 4 teaspoons) and answer questionnaires regarding medical history, quality of life, and emotional well-being. Subjects will also receive a neurocognitive exam annually.
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 therapy | Experimental | Radiation: Proton radiationSingle arm study delivering fractionated proton therapy over 6 week (54-59.4 Gy(RBE)) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed low-grade gliomas OR Grade III anaplastic glioma with either or both IDH1 mutation or 1p/19q codeletion
- Subject must be indicated for radiation therapy
- Life expectancy greater than 5 years
- Willing to participate in rigorous neurocognitive evaluations at baseline and serially following treatment
- Able to speak and comprehend English
Key exclusion criteria (8 listed)
- Prior cranial radiation therapy
- Chemotherapy within 4 weeks prior to entering study
- Pregnant or breastfeeding
- Known brain metastases
- Baseline neurocognitive or emotional disorders
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 radiationTotal dose of 54-59.4 Gy(RBE) at 1.8 Gy(RBE) per daily fraction delivered 5 days per week on weekdays for 6-6.5 weeks. | Radiation | Proton radiation therapy |
Primary outcome
Efficacy
Time frame: 7 years
To assess progression free survival of this treatment program.
2 secondary outcomes
Safety and Tolerability
Time frame: 7 years
Overall survival
Time frame: 7 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 10 Dec 2025.
Related trials for Low Grade Glioma
RecruitingPhase 2
Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
BRAF V600 Mutation, Low-grade Glioma
Active, not recruitingPhase 2
Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype
Glioma, Glioblastoma
Active, not recruitingPhase 3
DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Low-grade Glioma, Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma
RecruitingPhase 1/2
Phase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK
Pediatric Low-grade Glioma
Not yet recruiting
A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas
Glioma, Glioma Intracranial
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton radiation in people with Low Grade Glioma and WHO Grade 3 Glioma With IDH1 Mutation, run by Massachusetts General Hospital 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 7 inclusion and 8 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 10 Dec 2025. 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.
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?
Efficacy (time frame: 7 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 10 Dec 2025.