A Phase 3 interventional study of Standard Treatment and Higher Dose in Benign Meningioma, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-14.
Sponsored by Massachusetts General Hospital · Phase 3, Interventional, and Treatment
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.
226 studies on the registry are indexed under Meningioma; 87 are open to participants now.
This study's enrollment of 44 is close to the median of 40 across 161 interventional studies indexed under Meningioma.
Browse Meningioma studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Radiation: Standard Treatment
63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.
Radiation: Higher Dose
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.
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.
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.
Time frame: 5, 10, 15 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 15 Years
| Milestone | Standard Treatment | Higher Dose Treatment |
|---|---|---|
| Started | 22 | 22 |
| Completed | 22 | 22 |
| Not completed | 0 | 0 |
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.
| percentage of participants surviving | Standard Treatment | Higher Dose Treatment |
|---|---|---|
| Entire Cohort: 5 Years | 91 (68 to 98) | 91 (68 to 98) |
| Entire Cohort: 10 Years | 86 (62 to 95) | 81 (58 to 93) |
| Entire Cohort: 15 Years | 52 (28 to 72) | 70 (45 to 86) |
| Subtotal Resection: 5 Years | 100 (NA to NA) | 83 (48 to 96) |
| Subtotal Resection: 10 Years | 91 (51 to 99) | 67 (34 to 86) |
| Subtotal Resection: 15 Years | 64 (30 to 85) | 57 (25 to 80) |
| Recurrent Disease: 5 Years | 82 (45 to 95) | 100 (NA to NA) |
| Recurrent Disease: 10 Years | 82 (45 to 95) | 100 (NA to NA) |
| Recurrent Disease: 15 Years | 65 (24 to 88) | 100 (NA to NA) |
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.
| participants | Standard Treatment | Higher Dose Treatment |
|---|---|---|
| Vision loss | 2 | 1 |
| Visual field deficit | 1 | 0 |
| Diplopia | 2 | 0 |
| Ptosis | 0 | 1 |
| Exophthalmos | 1 | 0 |
| Conjunctivitis | 1 | 2 |
| Eye, other | 2 | 5 |
| Hearing loss | 1 | 2 |
| Tinnitus | 0 | 1 |
| Olfactory alteration | 1 | 1 |
| Gustation alteration | 3 | 1 |
| Neuromotor deficit | 1 | 0 |
| Weakness | 1 | 0 |
| Facial numbness | 2 | 1 |
| Facial weakness | 2 | 2 |
| Ataxia | 1 | 0 |
| Seizure | 1 | 1 |
| Headache | 3 | 8 |
| Nausea | 9 | 8 |
| Dizziness | 1 | 1 |
| Vertigo | 1 | 4 |
| Syncope | 1 | 0 |
| Depression | 0 | 3 |
| Neurocog deficit | 1 | 3 |
| Endocrine deficit | 0 | 1 |
| Skin changes | 16 | 18 |
| Alopecia | 7 | 11 |
| Fatigue | 12 | 10 |
The number of participants that experienced the specified late toxicities (any grade) as assessed by Radiation Therapy Oncology Group Late Effects Scale.
| participants | Standard Treatment | Higher Dose Treatment |
|---|---|---|
| Vision loss | 5 | 2 |
| Visual field deficit | 5 | 1 |
| Diplopia | 1 | 3 |
| Exophthalmos | 0 | 2 |
| Eye, other | 3 | 2 |
| Hearing loss | 6 | 4 |
| Tinnitus | 2 | 3 |
| Olfactory alteration | 0 | 2 |
| Gustation alteration | 0 | 1 |
| Dysphasia | 0 | 1 |
| Neuromotor deficit | 1 | 0 |
| Weakness | 1 | 2 |
| Facial numbness | 1 | 4 |
| Facial weakness | 4 | 2 |
| Ataxia | 2 | 3 |
| Fall | 0 | 3 |
| Dysarthria | 1 | 0 |
| Headache | 5 | 3 |
| Dizziness | 1 | 0 |
| Vertigo | 1 | 1 |
| Depression | 0 | 1 |
| Neurocognative deficit | 7 | 6 |
| Endocrine deficit | 7 | 10 |
| Osteoporosis | 0 | 1 |
| Cerebral edema | 1 | 0 |
| Brain atrophy | 0 | 1 |
| Skin changes | 1 | 1 |
| Alopecia | 0 | 2 |
| Fatigue | 4 | 3 |
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.
| participants | Standard Treatment | Higher Dose Treatment |
|---|---|---|
| Entire Cohort | 3 | 2 |
| Post-operative subgroup | 0 | 1 |
| Tumor recurrence subgroup | 3 | 1 |
Collected over 90 Days, 15 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Treatment | 14/22 (63.6%) | 6/22 (27.3%) | 22/22 (100%) |
| Higher Dose Treatment | 5/22 (22.7%) | 0/22 (0%) | 22/22 (100%) |
| Event | Standard Treatment | Higher Dose Treatment |
|---|---|---|
| Neuromotor deficitNervous system disorders | 2/22 | 0/22 |
| Vision lossEye disorders | 2/22 | 0/22 |
| Endocrine deficitEndocrine disorders | 1/22 | 0/22 |
| Cerebral edemaGeneral disorders | 1/22 | 0/22 |
| Event | Standard Treatment | Higher Dose Treatment |
|---|---|---|
| Skin changesSkin and subcutaneous tissue disorders | 17/22 | 19/22 |
| FatigueGeneral disorders | 16/22 | 13/22 |
| AlopeciaSkin and subcutaneous tissue disorders | 7/22 | 13/22 |
| HeadacheNervous system disorders | 8/22 | 11/22 |
| Endocrine deficitEndocrine disorders | 6/22 | 11/22 |
| NauseaGastrointestinal disorders | 9/22 | 8/22 |
| Neurocog deficitNervous system disorders | 8/22 | 9/22 |
| Eye, otherEye disorders | 5/22 | 7/22 |
| Hearing lossEar and labyrinth disorders | 7/22 | 6/22 |
| Visual field deficitEye disorders | 6/22 | 1/22 |
| Age, Continuous(years) | Standard Treatment | Higher Dose Treatment | Total |
|---|---|---|---|
| Median | 61 (31 to 77) | 50.5 (38 to 76) | 55.5 (31 to 76) |
| Sex: Female, Male(Participants) | Standard Treatment | Higher Dose Treatment | Total |
|---|---|---|---|
| Female | 14 | 15 | 29 |
| Male | 8 | 7 | 15 |
| Region of Enrollment(participants) | Standard Treatment | Higher Dose Treatment | Total |
|---|---|---|---|
| United States | 22 | 22 | 44 |
| Tumor Location(Tumors) | Standard Treatment | Higher Dose Treatment | Total |
|---|---|---|---|
| Sphenoid wing | 7 | 8 | 15 |
| Cavernous sinus | 3 | 8 | 11 |
| Sella/Parasella | 6 | 2 | 8 |
| Cerebellar pontine angle | 3 | 1 | 4 |
| Clival/prepontine space | 3 | 1 | 4 |
| Olfactory groove | 1 | 0 | 1 |
| Optic canal | 0 | 1 | 1 |
| Tentorium | 0 | 1 | 1 |
| Smoking Status(Participants) | Standard Treatment | Higher Dose Treatment | Total |
|---|---|---|---|
| Smoker | 9 | 13 | 22 |
| Non-smoker | 11 | 6 | 17 |
| Unknown | 2 | 3 | 5 |
| Co-morbidities(participants) | Standard Treatment | Higher Dose Treatment | Total |
|---|---|---|---|
| Hypertension | 3 | 6 | 9 |
| Diabetes mellitus | 0 | 4 | 4 |
| Hyperlipidemia | 1 | 0 | 1 |
| Coronary artery disease | 1 | 0 | 1 |
| One or more of the above | 4 | 6 | 10 |
| Radiation Indication(Participants) | Standard Treatment | Higher Dose Treatment | Total |
|---|---|---|---|
| Sub-Total Resection, postoperative | 11 | 12 | 23 |
| Recurrent Disease | 11 | 10 | 21 |
| Gross Tumor Volume(Cubic Centimeters) | Standard Treatment | Higher Dose Treatment | Total |
|---|---|---|---|
| Median | 39.7 (5.6 to 243) | 13.2 (3 to 313) | 26.5 (3 to 313) |
1 further baseline measures are reported on the registry.
Plan to share: No
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Massachusetts General Hospital