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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Higher Dose Treatment | Experimental | 63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Treatment | Radiation | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5, 10, 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 Days |
| Late Toxicities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen A Shih, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hosital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment | Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Standard Treatment: 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. |
| FG001 | Higher Dose Treatment | 63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment | Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Standard Treatment: 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. |
| BG001 | Higher Dose Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Progression free survival in the entire cohort and by radiation indication sub-groups | Posted | Number | 95% Confidence Interval | percentage of participants surviving | 5, 10, 15 years |
|
90 Days, 15 years
Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Treatment | Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Standard Treatment: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neuromotor deficit | Nervous system disorders | RTOG CTC | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision loss | Eye disorders | RTOG CTC | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nina Sanford, MD | Massachusetts General Hospital | NSANFORD@PARTNERS.ORG |
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| ID | Term |
|---|---|
| D008579 | Meningioma |
| ID | Term |
|---|---|
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
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| Higher Dose | Radiation | 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. |
|
The number of participants that experienced the specified late toxicities (any grade) as assessed by Radiation Therapy Oncology Group Late Effects Scale. |
| 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. | 15 Years |
63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tumor Location | Count of tumors by location | Number | Tumors |
|
| Smoking Status | Count of Participants | Participants |
|
| Co-morbidities | Number | participants |
|
| Radiation Indication | Count of Participants | Participants |
|
| Gross Tumor Volume | Median | Full Range | Cubic Centimeters |
|
| Clinical Target Volume | Median | Full Range | Cubic Centimeters |
|
| OG001 | Higher Dose Treatment | 63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. 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. |
|
|
|
| Secondary | 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. | Posted | Number | participants | 90 Days |
|
|
|
| Secondary | Late Toxicities | The number of participants that experienced the specified late toxicities (any grade) as assessed by Radiation Therapy Oncology Group Late Effects Scale. | Posted | Number | participants | 5 Years |
|
|
|
| Secondary | 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. | Failure rates are shown by dose group in the overall study population and by treatment indication subgroups. | Posted | Number | participants | 15 Years |
|
|
|
| 14 |
| 22 |
| 6 |
| 22 |
| 22 |
| 22 |
| EG001 | Higher Dose Treatment | 63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. 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. | 5 | 22 | 0 | 22 | 22 | 22 |
| Vision loss | Eye disorders | RTOG CTC | Systematic Assessment |
|
| Endocrine deficit | Endocrine disorders | RTOG CTC | Systematic Assessment |
|
| Cerebral edema | General disorders | RTOG CTC | Systematic Assessment |
|
| Visual field deficit | Eye disorders | RTOG CTC | Systematic Assessment |
|
| Diplopia | Eye disorders | RTOG CTC | Systematic Assessment |
|
| Ptosis | Eye disorders | RTOG CTC | Systematic Assessment |
|
| Exophthalmos | Eye disorders | RTOG CTC | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | RTOG CTC | Systematic Assessment |
|
| Eye, other | Eye disorders | RTOG CTC | Systematic Assessment |
|
| Hearing loss | Ear and labyrinth disorders | RTOG CTC | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | RTOG CTC | Systematic Assessment |
|
| Olfactory alteration | Respiratory, thoracic and mediastinal disorders | RTOG CTC | Systematic Assessment |
|
| Gustation alteration | Gastrointestinal disorders | RTOG CTC | Systematic Assessment |
|
| Dysphasia | Gastrointestinal disorders | RTOG CTC | Systematic Assessment |
|
| Neuromotor deficit | Nervous system disorders | RTOG CTC | Systematic Assessment |
|
| Weakness | General disorders | RTOG CTC | Systematic Assessment |
|
| Facial numbness | Nervous system disorders | RTOG CTC | Systematic Assessment |
|
| Facial weakness | Musculoskeletal and connective tissue disorders | RTOG CTC | Systematic Assessment |
|
| Ataxia | Nervous system disorders | RTOG CTC | Systematic Assessment |
|
| Fall | General disorders | RTOG CTC | Systematic Assessment |
|
| Seizure | Nervous system disorders | RTOG CTC | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | RTOG CTC | Systematic Assessment |
|
| Headache | Nervous system disorders | RTOG CTC | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | RTOG CTC | Systematic Assessment |
|
| Dizziness | Nervous system disorders | RTOG CTC | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | RTOG CTC | Systematic Assessment |
|
| Syncope | Nervous system disorders | RTOG CTC | Systematic Assessment |
|
| Depression | Psychiatric disorders | RTOG CTC | Systematic Assessment |
|
| Neurocog deficit | Nervous system disorders | RTOG CTC | Systematic Assessment |
|
| Endocrine deficit | Endocrine disorders | RTOG CTC | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | RTOG CTC | Systematic Assessment |
|
| Cerebral edema | Nervous system disorders | RTOG CTC | Systematic Assessment |
|
| Brain atrophy | Nervous system disorders | RTOG CTC | Systematic Assessment |
|
| Skin changes | Skin and subcutaneous tissue disorders | RTOG CTC | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | RTOG CTC | Systematic Assessment |
|
| Fatigue | General disorders | RTOG CTC | Systematic Assessment |
|
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| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| Diplopia |
|
| Ptosis |
|
| Exophthalmos |
|
| Conjunctivitis |
|
| Eye, other |
|
| Hearing loss |
|
| Tinnitus |
|
| Olfactory alteration |
|
| Gustation alteration |
|
| Neuromotor deficit |
|
| Weakness |
|
| Facial numbness |
|
| Facial weakness |
|
| Ataxia |
|
| Seizure |
|
| Headache |
|
| Nausea |
|
| Dizziness |
|
| Vertigo |
|
| Syncope |
|
| Depression |
|
| Neurocog deficit |
|
| Endocrine deficit |
|
| Skin changes |
|
| Alopecia |
|
| Fatigue |
|
| Diplopia |
|
| Exophthalmos |
|
| Eye, other |
|
| Hearing loss |
|
| Tinnitus |
|
| Olfactory alteration |
|
| Gustation alteration |
|
| Dysphasia |
|
| Neuromotor deficit |
|
| Weakness |
|
| Facial numbness |
|
| Facial weakness |
|
| Ataxia |
|
| Fall |
|
| Dysarthria |
|
| Headache |
|
| Dizziness |
|
| Vertigo |
|
| Depression |
|
| Neurocognative deficit |
|
| Endocrine deficit |
|
| Osteoporosis |
|
| Cerebral edema |
|
| Brain atrophy |
|
| Skin changes |
|
| Alopecia |
|
| Fatigue |
|
| Post-operative subgroup |
|
|
| Tumor recurrence subgroup |
|
|