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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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In this research study, we are looking to study the side effects from the use of proton radiation in treating people with low-grade gliomas that are recommended radiation treatment. We expect response of the tumors to be the same with proton radiation as compared to standard 3D conformal radiation therapy, but also expect less side effects from radiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton Radiation Therapy | Experimental | Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Radiation Therapy | Radiation | Once daily, Monday through Friday, for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Late Effects > 3 Months Post RT | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Progression Free Survival | Clinical and/or radiographic assessments Percentages were estimated by Kaplan Meier | At 1, 3, and 5 years |
| Percentage of Participants With Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen A. Shih, MD, MS, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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A large number of patients with brain tumors in the greater area are referred to one or more of the MGH multidisciplinary brain tumor specialists for evaluation and further care.
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| ID | Title | Description |
|---|---|---|
| FG000 | Proton Radiation Therapy | Proton Radiation Therapy daily (Monday through Friday) for six weeks. This is a single arm study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All 20 baseline participants were included in analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Proton Radiation Therapy | Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study. |
| 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 | Number of Participants With Late Effects > 3 Months Post RT | Posted | Count of Participants | Participants | No | 5 years |
|
|
Up to 5 years post RT
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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 | Proton Radiation Therapy | Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue, acute | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helen A. Shih, MD | Massachusetts General Hospital | 617-724-9627 | HSHIH@Partners.org |
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| ID | Term |
|---|---|
| D011522 | Protons |
| ID | Term |
|---|---|
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 |
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Percentages were estimated by Kaplan Meier
| At 1, 3, and 5 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Percentage of Participants With Progression Free Survival | Clinical and/or radiographic assessments Percentages were estimated by Kaplan Meier | Posted | Number | % of participants | No | At 1, 3, and 5 years |
|
|
|
| Secondary | Percentage of Participants With Overall Survival | Percentages were estimated by Kaplan Meier | Posted | Number | % of participants | At 1, 3, and 5 years |
|
|
|
| 0 |
| 20 |
| 20 |
| 20 |
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache, acute | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Seizure, acute | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste/Smell Alteration, acute | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia, acute | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cognitive Deficit | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea/Vomiting, acute | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Paresthesia, acute | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness, acute | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia, acute | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Motor Dysfunction | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Photophobia | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hearing | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Temperature Sensitivity | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weakness, cranial nerve | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weakness, peripheral | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Stuttering, twitching | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cognitive dysarthria | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Visual disturbance, other than loss | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vision Loss | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Proprioceptive deficit | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| fatigue, late | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| headache, late | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Seizure, late | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste/smell alteration, late | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia, late | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea/Vomiting, late | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Paresthesia, late | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness, late | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia, late | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |