Benign MeningiomaPhase 3NCT02947984
Proton/Photon Rt - Benign Meningiomas(P92-13)
A Phase 3 study testing Standard Treatment and Higher Dose in people with Benign Meningioma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine the best radiation dose for participants with meningioma that has grown back after previous surgery, or which the surgeon has been unable to remove completely. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Meningioma
- What is being tested?
- Standard Treatment and Higher Dose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Sep 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 or over
- Histological documentation of benign meningioma
- Documentation by imaging studies (CT and/ or MRI) or residual or recurrent intracranial tumor
- Karnofsky performance status of ≥ 70
- Study specific informed consent
Who cannot join
- Malignant meningiomas
- Prior cranial irradiation, except treatment of localized skin cancer of the face or scalp
- Patients having a concurrent primary cancer (except skin)
- Patients having another cancer controlled < 3 years
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hosital
Boston, Massachusetts, 02114
About this study
Official title: Prospective Study Of Patients With Recurrent Or Incomplete Excised Benign Intercranial Meningiomas For The Evaluation Of Treatment Result With Combined Proton And Photon Irradiation To Doses 55.8 Or 63.0 CGE
The purpose of this study is to determine the best radiation dose for participants with meningioma that has grown back after previous surgery, or which the surgeon has been unable to remove completely. This research study is designed to determine whether a higher dose of radiation will decrease the likelihood that the tumor will grow back, compared to the probability of re-growth that occurs after standard radiation doses.
Read the detailed description
- After initial interview and physical examination, an immobilization device (head mask, neck support, back support, etc.) will be made for the participant. A treatment planning CT will be performed and a radiation treatment plan will be based on this CT scan.
- The radiation dose will usually be given once a day, five days per week. The radiation treatment will take between 7 and 8 1/2 weeks, including treatment planning.
- Treatment doses will vary, and the dose each participant will receive will be made on the basis of random assignment. Participants will either receive the usual dose of 55.8 CGE in 31 treatments or 1.8 CGE, or 63 CGE in 35 treatments of 1.8 CGE.
- Conditions
- Benign Meningioma
- Being tested
- Standard Treatment, Higher Dose
- Keywords
- sphenoid region, parasellar area, photon radiation therapy, proton radiation therapy
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TreatmentRadiation
55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
Higher DoseRadiation
55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Experimental | Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Receives: Radiation: Standard Treatment |
| Higher Dose Treatment | Experimental | 63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. Receives: Radiation: Higher Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
The number of participants surviving at the given time point. Progression free survival (PFS) is measured from the starting date of radiation therapy and analyzed by intention to treat. PFS is measured until the earlier, date of death or development of radiologic progression, and is otherwise censored at the last follow-up for progression-free patients still alive.
Measured: 5, 10, 15 years
Secondary outcomes (3)
Acute Toxicities
The number of participants that experienced the specified acute toxicities (any grade) as assessed by Radiation Therapy Oncology Acute Morbidity Scoring Criteria. Acute toxicities were assessed from the start of treatment through day 90 of treatment.
Measured: 90 Days
Late Toxicities
The number of participants that experienced the specified late toxicities (any grade) as assessed by Radiation Therapy Oncology Group Late Effects Scale.
Measured: 5 Years
Local Failure Rate
The number of participants with local failure. Local failure is defined as radiologic progression seen on follow-up scans showing tumor margin(s) extending in any direction at least five mm beyond that seen on baseline scans.
Measured: 15 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startMar 1999
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- 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
- NCT02947984
- Sponsor's protocol ID
- 97-550
- Status last verified
- May 2017
- First submitted
- 28 Dec 2007
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Of Patients With Recurrent Or Incomplete Excised Benign Intercranial Meningiomas For The Evaluation Of Treatment Result With Combined Proton And Photon Irradiation To Doses 55.8 Or 63.0 CGE
- ClinicalTrials.gov ID
- NCT02947984
- Acronym / sponsor ID
- 97-550
- Conditions
- Benign Meningioma
- Keywords
- sphenoid region, parasellar area, photon radiation therapy, proton radiation therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 1999
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the best radiation dose for participants with meningioma that has grown back after previous surgery, or which the surgeon has been unable to remove completely. This research study is designed to determine whether a higher dose of radiation will decrease the likelihood that the tumor will grow back, compared to the probability of re-growth that occurs after standard radiation doses.
Detailed description
- After initial interview and physical examination, an immobilization device (head mask, neck support, back support, etc.) will be made for the participant. A treatment planning CT will be performed and a radiation treatment plan will be based on this CT scan.
- The radiation dose will usually be given once a day, five days per week. The radiation treatment will take between 7 and 8 1/2 weeks, including treatment planning.
- Treatment doses will vary, and the dose each participant will receive will be made on the basis of random assignment. Participants will either receive the usual dose of 55.8 CGE in 31 treatments or 1.8 CGE, or 63 CGE in 35 treatments of 1.8 CGE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Experimental | Radiation: Standard TreatmentStandard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. |
| Higher Dose Treatment | Experimental | Radiation: Higher Dose63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or over
- Histological documentation of benign meningioma
- Documentation by imaging studies (CT and/ or MRI) or residual or recurrent intracranial tumor
- Karnofsky performance status of ≥ 70
- Study specific informed consent
Key exclusion criteria (5 listed)
- Malignant meningiomas
- Prior cranial irradiation, except treatment of localized skin cancer of the face or scalp
- Patients having a concurrent primary cancer (except skin)
- Patients having another cancer controlled < 3 years
- Pregnant patients
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 |
|---|---|---|
| Standard Treatment55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT. | Radiation | Standard Treatment |
| Higher Dose55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT. | Radiation | Higher Dose Treatment |
Primary outcome
Progression Free Survival
Time frame: 5, 10, 15 years
The number of participants surviving at the given time point. Progression free survival (PFS) is measured from the starting date of radiation therapy and analyzed by intention to treat. PFS is measured until the earlier, date of death or development of radiologic progression, and is otherwise censored at the last follow-up for progression-free patients still alive.
3 secondary outcomes
Acute Toxicities
Time frame: 90 Days
Late Toxicities
Time frame: 5 Years
Local Failure Rate
Time frame: 15 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard Treatment and Higher Dose in people with Benign Meningioma, 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 5 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: finished, as of the sponsor's last update on 14 Jun 2017. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (time frame: 5, 10, 15 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 14 Jun 2017; AzTrials last refreshed its copy on 3 Nov 2026.