Trial Outcomes & Findings for Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation (NCT NCT01288235)

NCT ID: NCT01288235

Last Updated: 2025-06-03

Results Overview

Cumulative incidence (estimated percentage participants) that developed endocrine dysfunction at 3- and 5-years following completion of proton radiation therapy.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 100 participants
• Primary outcome timeframe: 3- and 5- years post radiation treatment
• Results posted on: 2025-06-03

Participant Flow

Participant milestones

Measure	Proton Radiotherapy Proton Radiotherapy Proton radiotherapy: 5 days a week
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation

Baseline characteristics by cohort

Measure	Proton Radiotherapy n=100 Participants Proton Radiotherapy Proton radiotherapy: 5 days a week
Age, Continuous	8.0 years n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	80 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 3- and 5- years post radiation treatment

Population: Patient population at risk of developing an endocrine dysfunction during follow-up

Cumulative incidence (estimated percentage participants) that developed endocrine dysfunction at 3- and 5-years following completion of proton radiation therapy.

Outcome measures

Measure	Proton Radiotherapy n=99 Participants Proton Radiotherapy Proton radiotherapy: 5 days a week
Endocrine Dysfunction 3-Years post RT	14.5 percentage of participants Interval 8.3 to 22.3
Endocrine Dysfunction 5-Years post RT	20.2 percentage of participants Interval 12.7 to 28.9

PRIMARY outcome

Timeframe: 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.

Population: Patients who received neurocognitive testing at both baseline and post radiation treatment

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.

Outcome measures

Measure	Proton Radiotherapy n=49 Participants Proton Radiotherapy Proton radiotherapy: 5 days a week
Neurocognitive Sequelae Baseline FSIQ	99.2 score on a scale Standard Deviation 14.8
Neurocognitive Sequelae Latest Follow-up FSIQ	100.3 score on a scale Standard Deviation 16.2

SECONDARY outcome

Timeframe: 3- and 5- years post radiation treatment

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.

Outcome measures

Measure	Proton Radiotherapy n=100 Participants Proton Radiotherapy Proton radiotherapy: 5 days a week
Disease Control Local Control 3-Year post RT	89.9 percent probability Interval 83.1 to 94.9
Disease Control Local Control 5-Year post RT	85.9 percent probability Interval 78.2 to 91.9
Disease Control Distant Control 3-Year post RT	97.0 percent probability Interval 92.1 to 99.2
Disease Control Distant Control 5-Year post RT	95.0 percent probability Interval 89.4 to 98.1

SECONDARY outcome

Timeframe: 3- and 5- years post radiation treatment

Population: Patients at risk of developing a grade 3 or higher toxicity following proton radiation

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

Outcome measures

Measure	Proton Radiotherapy n=99 Participants Proton Radiotherapy Proton radiotherapy: 5 days a week
Cumulative Incidence of Grade 3+ Toxicities 3-Years post RT	12.2 percentage of participants Interval 6.6 to 19.5
Cumulative Incidence of Grade 3+ Toxicities 5-Years post RT	16.3 percentage of participants Interval 9.8 to 24.3

SECONDARY outcome

Timeframe: 3- and 5- years post radiation treatment

Population: 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

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.

Outcome measures

Measure	Proton Radiotherapy n=28 Participants Proton Radiotherapy Proton radiotherapy: 5 days a week
Cumulative Incidence of Ototoxicity 3-Years post RT	12.5 percentage of participants Interval 2.9 to 29.5
Cumulative Incidence of Ototoxicity 5-Years post RT	12.5 percentage of participants Interval 2.9 to 29.5

Adverse Events

Proton Radiotherapy

Serious events: 2 serious events

Other events: 98 other events

Deaths: 15 deaths

Serious adverse events

Measure	Proton Radiotherapy n=100 participants at risk Proton Radiotherapy Proton radiotherapy: 5 days a week
Metabolism and nutrition disorders Hypernatremia	1.0% 1/100 • 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)
Investigations Lymphocyte Count Decreased	1.0% 1/100 • 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)

Other adverse events

Measure	Proton Radiotherapy n=100 participants at risk Proton Radiotherapy Proton radiotherapy: 5 days a week
Blood and lymphatic system disorders Febrile neutropenia	1.0% 1/100 • 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)
Ear and labyrinth disorders Ear and labyrinth disorders - Other	3.0% 3/100 • 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)
Ear and labyrinth disorders Ear pain	2.0% 2/100 • 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)
Ear and labyrinth disorders External ear pain	1.0% 1/100 • 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)
Ear and labyrinth disorders Hearing impaired	8.0% 8/100 • 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)
Ear and labyrinth disorders Middle ear inflammation	1.0% 1/100 • 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)
Ear and labyrinth disorders Tinnitus	1.0% 1/100 • 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)
Endocrine disorders Adrenal insufficiency	8.0% 8/100 • 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)
Endocrine disorders Delayed puberty	1.0% 1/100 • 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)
Endocrine disorders Endocrine disorders - Other	22.0% 22/100 • 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)
Endocrine disorders Hyperthyroidism	1.0% 1/100 • 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)
Endocrine disorders Hypoparathyroidism	1.0% 1/100 • 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)
Endocrine disorders Hypothyroidism	8.0% 8/100 • 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)
Endocrine disorders Precocious puberty	4.0% 4/100 • 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)
Eye disorders Blurred vision	4.0% 4/100 • 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)
Eye disorders Cataract	1.0% 1/100 • 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)
Eye disorders Eye disorders - Other	14.0% 14/100 • 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)
Eye disorders Eyelid function disorder	1.0% 1/100 • 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)
Eye disorders Optic nerve disorder	5.0% 5/100 • 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)
Eye disorders Photophobia	1.0% 1/100 • 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)
Gastrointestinal disorders Constipation	1.0% 1/100 • 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)
Gastrointestinal disorders Diarrhea	1.0% 1/100 • 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)
Gastrointestinal disorders Dysphagia	1.0% 1/100 • 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)
Gastrointestinal disorders Flatulence	1.0% 1/100 • 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)
Gastrointestinal disorders Gastroesophageal reflux disease	1.0% 1/100 • 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)
Gastrointestinal disorders Gastrointestinal disorders - Other	1.0% 1/100 • 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)
Gastrointestinal disorders Nausea	34.0% 34/100 • 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)
Gastrointestinal disorders Stomach pain	1.0% 1/100 • 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)
Gastrointestinal disorders Vomiting	18.0% 18/100 • 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)
General disorders Fatigue	84.0% 84/100 • 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)
General disorders General disorders and administration site conditions - Other	3.0% 3/100 • 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)
General disorders Pain	1.0% 1/100 • 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)
Infections and infestations Infections and infestations - Other, specify	3.0% 3/100 • 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)
Infections and infestations Sinusitis	1.0% 1/100 • 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)
Infections and infestations Upper respiratory infection	1.0% 1/100 • 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)
Injury, poisoning and procedural complications Dermatitis radiation	46.0% 46/100 • 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)
Injury, poisoning and procedural complications Fall	2.0% 2/100 • 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)
Investigations Blood gonadotrophin abnormal	1.0% 1/100 • 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)
Investigations Blood prolactin abnormal	3.0% 3/100 • 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)
Investigations Growth hormone abnormal	26.0% 26/100 • 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)
Investigations Investigations - Other	1.0% 1/100 • 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)
Investigations Weight gain	9.0% 9/100 • 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)
Investigations Weight loss	4.0% 4/100 • 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)
Investigations White blood cell decreased	1.0% 1/100 • 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)
Metabolism and nutrition disorders Anorexia	24.0% 24/100 • 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)
Metabolism and nutrition disorders Obesity	7.0% 7/100 • 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)
Musculoskeletal and connective tissue disorders Back pain	1.0% 1/100 • 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)
Musculoskeletal and connective tissue disorders Growth suppression	9.0% 9/100 • 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)
Musculoskeletal and connective tissue disorders Kyphosis	1.0% 1/100 • 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)
Musculoskeletal and connective tissue disorders Musculoskeletal deformity	3.0% 3/100 • 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)
Musculoskeletal and connective tissue disorders Neck pain	1.0% 1/100 • 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)
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	3.0% 3/100 • 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	2.0% 2/100 • 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)
Nervous system disorders IVth nerve disorder	3.0% 3/100 • 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)
Nervous system disorders Somnolence	2.0% 2/100 • 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)
Nervous system disorders Abducens nerve disorder	2.0% 2/100 • 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)
Nervous system disorders Ataxia	8.0% 8/100 • 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)
Nervous system disorders Cognitive disturbance	28.0% 28/100 • 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)
Nervous system disorders Concentration impairment	10.0% 10/100 • 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)
Nervous system disorders Dizziness	3.0% 3/100 • 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)
Nervous system disorders Dysarthria	1.0% 1/100 • 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)
Nervous system disorders Dysesthesia	1.0% 1/100 • 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)
Nervous system disorders Dysphasia	1.0% 1/100 • 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)
Nervous system disorders Facial muscle weakness	1.0% 1/100 • 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)
Nervous system disorders Facial nerve disorder	2.0% 2/100 • 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)
Nervous system disorders Headache	31.0% 31/100 • 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)
Nervous system disorders Hydrocephalus	1.0% 1/100 • 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)
Nervous system disorders Hypersomnia	1.0% 1/100 • 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)
Nervous system disorders Intracranial hemorrhage	1.0% 1/100 • 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)
Nervous system disorders Lethargy	1.0% 1/100 • 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)
Nervous system disorders Memory impairment	22.0% 22/100 • 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)
Nervous system disorders Muscle weakness left-sided	3.0% 3/100 • 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)
Nervous system disorders Muscle weakness right-sided	2.0% 2/100 • 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)
Nervous system disorders Nervous system disorders - Other	6.0% 6/100 • 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)
Nervous system disorders Nystagmus	5.0% 5/100 • 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)
Nervous system disorders Oculomotor nerve disorder	1.0% 1/100 • 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)
Nervous system disorders Paresthesia	3.0% 3/100 • 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)
Nervous system disorders Peripheral sensory neuropathy	1.0% 1/100 • 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)
Nervous system disorders Seizure	2.0% 2/100 • 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)
Nervous system disorders Stroke	2.0% 2/100 • 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)
Nervous system disorders Tremor	2.0% 2/100 • 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)
Psychiatric disorders Anxiety	13.0% 13/100 • 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)
Psychiatric disorders Insomnia	3.0% 3/100 • 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)
Psychiatric disorders Irritability	7.0% 7/100 • 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)
Psychiatric disorders Psychiatric disorders - Other	3.0% 3/100 • 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)
Renal and urinary disorders Urinary frequency	1.0% 1/100 • 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)
Reproductive system and breast disorders Irregular menstruation	5.0% 5/100 • 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)
Respiratory, thoracic and mediastinal disorders Epistaxis	2.0% 2/100 • 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)
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.0% 1/100 • 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)
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	1.0% 1/100 • 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)
Skin and subcutaneous tissue disorders Alopecia	75.0% 75/100 • 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)
Skin and subcutaneous tissue disorders Dry skin	1.0% 1/100 • 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)
Skin and subcutaneous tissue disorders Photosensitivity	1.0% 1/100 • 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)
Skin and subcutaneous tissue disorders Pruritus	2.0% 2/100 • 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)
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	1.0% 1/100 • 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)
Skin and subcutaneous tissue disorders Skin hyperpigmentation	9.0% 9/100 • 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)
Vascular disorders Hematoma	1.0% 1/100 • 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)
Vascular disorders Vascular disorders - Other	4.0% 4/100 • 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)

Additional Information

Torunn I. Yock, MD

Massachusetts General, Hospital

Phone: 6177262000

Email: tyock@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place