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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| National Cancer Institute (NCI) | NIH |
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Some patients with brain tumors receive standard radiation to help prevent tumor growth. Although standard radiation kills tumor cells, it can also damage normal tissue in the process and lead to more side effects. This research study is looking at a different form of radiation called proton radiotherapy which helps spare normal tissues while delivering radiation to the tumor or tumor bed. Proton techniques irradiate 2-3 times less normal tissue then standard radiation. This therapy has been used in treatment of other cancers and information from those other research studies suggests that this therapy may help better target brain tumors then standard radiation.
- Participants will receive proton radiotherapy at the Francis H. Burr Proton Therapy Center which is located at the Massachusetts General Hospital. They will receive the proton radiotherapy 5 days per week. The number of weeks the participant will be receiving proton radiotherapy depends upon the tumor type and location and how well they are tolerating the treatment. Participant's will have a physical exam weekly during proton radiotherapy treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton Radiotherapy | Experimental | Proton Radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton radiotherapy | Radiation | 5 days a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endocrine Dysfunction | Cumulative incidence (estimated percentage participants) that developed endocrine dysfunction at 3- and 5-years following completion of proton radiation therapy. | 3- and 5- years post radiation treatment |
| Neurocognitive Sequelae | The overall change in neurocognitive outcomes between treatment and last-follow-up as assessed by Wechsler Intelligence Scale for Children version 4 (WISC-IV). The test measures the Full-Scale Intelligence Quotient (FSIQ) of children through four indices; the Verbal Comprehension Index (VCI), Perceptual Reasoning Index (PRI), working memory test, and a processing speed test. FSIQ and the four indices are all assessed on a bell curve scale with an average score of 100 and standard deviation of 15. Higher scores represent higher intelligence and lower scores represent reduced intelligence. | From the start of radiation treatment (baseline) to study completion. Participants were assessed annually up to 5 years following treatment completion. The median follow-up is 4.7 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control | Three and 5 year local and distant disease control survival probabilities. Participants were assessed each follow-up and categorized in the following ways: 1) disease controlled no evidence of progression, 2) disease not controlled, tumor has progressed 3) patient has suffered a second malignancy (new tumor unrelated to the one the participant was treated for). Disease failure (recurrence of primary tumor) can occur locally (at or near the site of the original tumor), distally (located further away from the original tumor site), or both. Participants who did not fail locally or in a distant site were censored at the date of their last follow-up, including death due to other causes. Disease control shows the percent probability of remaining recurrence free (disease is controlled) in follow-up post radiation treatment completion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torunn I. Yock, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30118397 | Derived | Vatner RE, Niemierko A, Misra M, Weyman EA, Goebel CP, Ebb DH, Jones RM, Huang MS, Mahajan A, Grosshans DR, Paulino AC, Stanley T, MacDonald SM, Tarbell NJ, Yock TI. Endocrine Deficiency As a Function of Radiation Dose to the Hypothalamus and Pituitary in Pediatric and Young Adult Patients With Brain Tumors. J Clin Oncol. 2018 Oct 1;36(28):2854-2862. doi: 10.1200/JCO.2018.78.1492. Epub 2018 Aug 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proton Radiotherapy | Proton Radiotherapy Proton radiotherapy: 5 days a week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Proton Radiotherapy | Proton Radiotherapy Proton radiotherapy: 5 days a week |
| 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 | Endocrine Dysfunction | Cumulative incidence (estimated percentage participants) that developed endocrine dysfunction at 3- and 5-years following completion of proton radiation therapy. | Patient population at risk of developing an endocrine dysfunction during follow-up | Posted | Number | 95% Confidence Interval | percentage of participants | 3- and 5- years post radiation treatment |
|
|
All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for up to 5 years after the completion of radiation treatment.
Toxicity assessments were done using NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0)
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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 Radiotherapy | Proton Radiotherapy Proton radiotherapy: 5 days a week | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Torunn I. Yock, MD | Massachusetts General, Hospital | 6177262000 | tyock@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D001254 | Astrocytoma |
| D004806 | Ependymoma |
| D018303 | Ganglioglioma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 3- and 5- years post radiation treatment |
| Cumulative Incidence of Grade 3+ Toxicities | Percentage of participants who experienced a toxicity following completion of radiation treatment as measured by the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) after the completion of radiation therapy. Cumulative incidence is shown at 3- and 5-years post treatment. The descriptions and grading scales found in the NCI Common Terminology Criteria | 3- and 5- years post radiation treatment |
| Cumulative Incidence of Ototoxicity | Cumulative incidence (estimated percentage participants) who experienced ototoxicity defined as either grade 3 or 4 hearing loss in either ear after the completion of radiation therapy in the overall participant population. Cumulative incidence and 95% confidence intervals are shown at 3- and 5-years post radiation treatment. | 3- and 5- years post radiation treatment |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Neurocognitive Sequelae | The overall change in neurocognitive outcomes between treatment and last-follow-up as assessed by Wechsler Intelligence Scale for Children version 4 (WISC-IV). The test measures the Full-Scale Intelligence Quotient (FSIQ) of children through four indices; the Verbal Comprehension Index (VCI), Perceptual Reasoning Index (PRI), working memory test, and a processing speed test. FSIQ and the four indices are all assessed on a bell curve scale with an average score of 100 and standard deviation of 15. Higher scores represent higher intelligence and lower scores represent reduced intelligence. | Patients who received neurocognitive testing at both baseline and post radiation treatment | Posted | Mean | Standard Deviation | score on a scale | From the start of radiation treatment (baseline) to study completion. Participants were assessed annually up to 5 years following treatment completion. The median follow-up is 4.7 years. |
|
|
|
|
| Secondary | Disease Control | Three and 5 year local and distant disease control survival probabilities. Participants were assessed each follow-up and categorized in the following ways: 1) disease controlled no evidence of progression, 2) disease not controlled, tumor has progressed 3) patient has suffered a second malignancy (new tumor unrelated to the one the participant was treated for). Disease failure (recurrence of primary tumor) can occur locally (at or near the site of the original tumor), distally (located further away from the original tumor site), or both. Participants who did not fail locally or in a distant site were censored at the date of their last follow-up, including death due to other causes. Disease control shows the percent probability of remaining recurrence free (disease is controlled) in follow-up post radiation treatment completion. | Posted | Number | 95% Confidence Interval | percent probability | 3- and 5- years post radiation treatment |
|
|
|
|
| Secondary | Cumulative Incidence of Grade 3+ Toxicities | Percentage of participants who experienced a toxicity following completion of radiation treatment as measured by the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) after the completion of radiation therapy. Cumulative incidence is shown at 3- and 5-years post treatment. The descriptions and grading scales found in the NCI Common Terminology Criteria | Patients at risk of developing a grade 3 or higher toxicity following proton radiation | Posted | Number | 95% Confidence Interval | percentage of participants | 3- and 5- years post radiation treatment |
|
|
|
|
| Secondary | Cumulative Incidence of Ototoxicity | Cumulative incidence (estimated percentage participants) who experienced ototoxicity defined as either grade 3 or 4 hearing loss in either ear after the completion of radiation therapy in the overall participant population. Cumulative incidence and 95% confidence intervals are shown at 3- and 5-years post radiation treatment. | Patients with audiograms completed at both baseline and follow-up and at risk of developing grade 3 or 4 high grade hearing loss in either ear after radiation treatment | Posted | Number | 95% Confidence Interval | percentage of participants | 3- and 5- years post radiation treatment |
|
|
|
|
| 100 |
| 2 |
| 100 |
| 98 |
| 100 |
| Lymphocyte Count Decreased | Investigations | Systematic Assessment |
|
| Ear and labyrinth disorders - Other | Ear and labyrinth disorders | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
|
| External ear pain | Ear and labyrinth disorders | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | Systematic Assessment |
|
| Middle ear inflammation | Ear and labyrinth disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | Systematic Assessment |
|
| Delayed puberty | Endocrine disorders | Systematic Assessment |
|
| Endocrine disorders - Other | Endocrine disorders | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
|
| Hypoparathyroidism | Endocrine disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Precocious puberty | Endocrine disorders | Systematic Assessment |
|
| Blurred vision | Eye disorders | Systematic Assessment |
|
| Cataract | Eye disorders | Systematic Assessment |
|
| Eye disorders - Other | Eye disorders | Systematic Assessment |
|
| Eyelid function disorder | Eye disorders | Systematic Assessment |
|
| Optic nerve disorder | Eye disorders | Systematic Assessment |
|
| Photophobia | Eye disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal disorders - Other | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| General disorders and administration site conditions - Other | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Blood gonadotrophin abnormal | Investigations | Systematic Assessment |
|
| Blood prolactin abnormal | Investigations | Systematic Assessment |
|
| Growth hormone abnormal | Investigations | Systematic Assessment |
|
| Investigations - Other | Investigations | Systematic Assessment |
|
| Weight gain | Investigations | Systematic Assessment |
|
| Weight loss | Investigations | Systematic Assessment |
|
| White blood cell decreased | Investigations | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Growth suppression | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Kyphosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal deformity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| IVth nerve disorder | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Abducens nerve disorder | Nervous system disorders | Systematic Assessment |
|
| Ataxia | Nervous system disorders | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | Systematic Assessment |
|
| Concentration impairment | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | Systematic Assessment |
|
| Dysesthesia | Nervous system disorders | Systematic Assessment |
|
| Dysphasia | Nervous system disorders | Systematic Assessment |
|
| Facial muscle weakness | Nervous system disorders | Systematic Assessment |
|
| Facial nerve disorder | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | Systematic Assessment |
|
| Intracranial hemorrhage | Nervous system disorders | Systematic Assessment |
|
| Lethargy | Nervous system disorders | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | Systematic Assessment |
|
| Muscle weakness left-sided | Nervous system disorders | Systematic Assessment |
|
| Muscle weakness right-sided | Nervous system disorders | Systematic Assessment |
|
| Nervous system disorders - Other | Nervous system disorders | Systematic Assessment |
|
| Nystagmus | Nervous system disorders | Systematic Assessment |
|
| Oculomotor nerve disorder | Nervous system disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Irritability | Psychiatric disorders | Systematic Assessment |
|
| Psychiatric disorders - Other | Psychiatric disorders | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
|
| Irregular menstruation | Reproductive system and breast disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Photosensitivity | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
| Vascular disorders - Other | Vascular disorders | Systematic Assessment |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
|
| Distant Control 5-Year post RT |
|
| 85.9 |
| 2-Sided |
| 95 |
| 78.2 |
| 91.9 |
| Other |
| 3-Year Distant Disease Control | 97.0 | 2-Sided | 95 | 92.1 | 99.2 | Other |
| 5-Year Distant Disease Control | 95.0 | 2-Sided | 95 | 89.4 | 98.1 | Other |
| 16.3 |
| 2-Sided |
| 95 |
| 9.8 |
| 24.3 |
| Other |
| 12.5 |
| 2-Sided |
| 95 |
| 2.9 |
| 29.5 |
| Other |