Trial Outcomes & Findings for Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma (NCT NCT01063114)

Last Updated: 2025-08-13

Results Overview

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 RT (radiation treatment)

Recruitment status

COMPLETED

Study phase

Target enrollment

90 participants

Primary outcome timeframe

3- and 5- years post radiation treatment

Results posted on

2025-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Proton Beam Radiation Proton Beam Radiation proton beam radiation: Given once a day, 5 days a week (Monday-Friday)
Overall Study STARTED	90
Overall Study COMPLETED	89
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Proton Beam Radiation Proton Beam Radiation proton beam radiation: Given once a day, 5 days a week (Monday-Friday)
Overall Study Lost to Follow-up	1

Baseline Characteristics

Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Proton Beam Radiation n=90 Participants Proton Beam Radiation proton beam radiation: Given once a day, 5 days a week (Monday-Friday)
Age, Continuous	8.3 years n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 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	1 Participants n=5 Participants
Race (NIH/OMB) White	79 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	90 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3- and 5- years post radiation treatment

Population: Subset of study population that were at risk of developing a grade 3 or 4 hearing loss in either ear in follow-up after the completion of radiation therapy.

Outcome measures

Outcome measures
Measure	Proton Beam Radiation n=77 Participants Proton Beam Radiation proton beam radiation: Given once a day, 5 days a week (Monday-Friday)
Cumulative Incidence of Ototoxicity 3-Years post RT (radiation treatment)	26 percentage of participants Interval 16.0 to 37.0
Cumulative Incidence of Ototoxicity 5-Years post RT	27 percentage of participants Interval 17.0 to 38.0

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

Outcome measures
Measure	Proton Beam Radiation n=90 Participants Proton Beam Radiation proton beam radiation: Given once a day, 5 days a week (Monday-Friday)
Endocrine Dysfunction 3-Years post RT	46 percentage of participants Interval 34.0 to 57.0
Endocrine Dysfunction 5-Years post RT	67 percentage of participants Interval 54.0 to 77.0

PRIMARY outcome

Timeframe: Baseline and Follow-up (median of 6 years)

Difference in Full-Scale Intelligence Quotient (FSIQ) between baseline and latest follow-up neurocognitive test. Tests used include WISC (Wechsler Intelligence Scale for Children) IV, WISC V, WAIS (Wechsler Adult Intelligence Scale) III, WAIS IV. The test measures the 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

Outcome measures
Measure	Proton Beam Radiation n=26 Participants Proton Beam Radiation proton beam radiation: Given once a day, 5 days a week (Monday-Friday)
Neurocognitive Effects Baseline FSIQ	102.7 score on a scale Standard Deviation 12.5
Neurocognitive Effects Follow-up FSIQ	91.7 score on a scale Standard Deviation 20.5

SECONDARY outcome

Timeframe: 3- and 5-years post radiation treatment

3- and 5-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment.

Outcome measures

Outcome measures
Measure	Proton Beam Radiation n=90 Participants Proton Beam Radiation proton beam radiation: Given once a day, 5 days a week (Monday-Friday)
Progression Free Survival 3-Year post RT	83.2 percentage of participants Interval 75.8 to 91.3
Progression Free Survival 5-Year post RT	79.6 percentage of participants Interval 71.7 to 88.5

SECONDARY outcome

Timeframe: 2 years

Population: It was not possible to change/alter any portion of the treatment process for those requiring CSI and therefore no patient had altered treatment times. Specifically, we were unable to speed the delivery of the radiation and make treatment scheduling slots shorter than they already were. With no changes in treatment speed across patients, potential outcomes in terms of safety and treatment efficiency could not be compared by treatment speed. This data will not be collected in the future.

To modify the speed of treating patients requiring cranial spinal irradiation (CSI) and improve the safety of treating patients under anesthesia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months after radiation therapy

All patients shall be assessed for acute toxicity on a weekly basis during craniospinal irradiation (CSI). Percentage of participants who experienced an acute toxicity by grade. Acute toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Toxicities are graded on a scale of 1 to 5. A higher grade indicates a worse outcome with 1 being mild, 4 being life-threatening, and 5 being death.

Outcome measures

Outcome measures
Measure	Proton Beam Radiation n=90 Participants Proton Beam Radiation proton beam radiation: Given once a day, 5 days a week (Monday-Friday)
Percentage of Participants Who Experienced an Acute Toxicity by Grade Grade 1	90 Participants
Percentage of Participants Who Experienced an Acute Toxicity by Grade Grade 2	84 Participants
Percentage of Participants Who Experienced an Acute Toxicity by Grade Grade 3	36 Participants
Percentage of Participants Who Experienced an Acute Toxicity by Grade Grade 4	12 Participants
Percentage of Participants Who Experienced an Acute Toxicity by Grade Grade 5	0 Participants

Adverse Events

Proton Beam Radiation

Serious events: 9 serious events

Other events: 89 other events

Deaths: 19 deaths

Serious adverse events

Serious adverse events
Measure	Proton Beam Radiation n=90 participants at risk Proton Beam Radiation proton beam radiation: Given once a day, 5 days a week (Monday-Friday)
Skin and subcutaneous tissue disorders Alopecia	3.3% 3/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Blood and lymphatic system disorders Anemia	3.3% 3/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Ear and labyrinth disorders Middle ear inflammation	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Eye disorders Dry eye	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Gastrointestinal disorders Esophagitis	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Gastrointestinal disorders Vomiting	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Infections and infestations Eye infection	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Injury, poisoning and procedural complications Dermatitis radiation	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Investigations Neutrophil count decreased	4.4% 4/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Investigations Weight loss	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Investigations White blood cell decreased	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Metabolism and nutrition disorders Anorexia	4.4% 4/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Metabolism and nutrition disorders Dehydration	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Headache	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Psychiatric disorders Anxiety	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Respiratory, thoracic and mediastinal disorders Sore throat	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Gastrointestinal disorders Dry mouth	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).

Other adverse events

Other adverse events
Measure	Proton Beam Radiation n=90 participants at risk Proton Beam Radiation proton beam radiation: Given once a day, 5 days a week (Monday-Friday)
Gastrointestinal disorders Abdominal pain	4.4% 4/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Psychiatric disorders Agitation	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Skin and subcutaneous tissue disorders Alopecia	90.0% 81/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Blood and lymphatic system disorders Anemia	26.7% 24/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Metabolism and nutrition disorders Anorexia	62.2% 56/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Psychiatric disorders Anxiety	8.9% 8/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Musculoskeletal and connective tissue disorders Back pain	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Skin and subcutaneous tissue disorders Bullous dermatitis	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Investigations CD4 lymphocytes decreased	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Gastrointestinal disorders Constipation	4.4% 4/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Respiratory, thoracic and mediastinal disorders Cough	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Metabolism and nutrition disorders Dehydration	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Psychiatric disorders Depression	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Injury, poisoning and procedural complications Dermatitis radiation	87.8% 79/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Gastrointestinal disorders Diarrhea	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Dizziness	7.8% 7/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Eye disorders Dry eye	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Gastrointestinal disorders Dry mouth	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Skin and subcutaneous tissue disorders Dry skin	11.1% 10/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Dysesthesia	3.3% 3/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Dysgeusia	11.1% 10/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Gastrointestinal disorders Dyspepsia	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Gastrointestinal disorders Dysphagia	4.4% 4/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Ear and labyrinth disorders Ear pain	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Skin and subcutaneous tissue disorders Erythema multiforme	7.8% 7/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Gastrointestinal disorders Esophageal pain	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Gastrointestinal disorders Esophagitis	6.7% 6/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Ear and labyrinth disorders External ear inflammation	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
General disorders Fatigue	80.0% 72/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
General disorders Gait disturbance	3.3% 3/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Musculoskeletal and connective tissue disorders Growth suppression	32.2% 29/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Headache	44.4% 40/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Ear and labyrinth disorders Hearing impaired	53.3% 48/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Metabolism and nutrition disorders Hyperglycemia	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Metabolism and nutrition disorders Hypokalemia	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Psychiatric disorders Insomnia	4.4% 4/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Investigations Lymphocyte count decreased	30.0% 27/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Infections and infestations Mucosal infection	3.3% 3/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Gastrointestinal disorders Mucositis oral	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Gastrointestinal disorders Nausea	66.7% 60/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Investigations Neutrophil count decreased	27.8% 25/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
General disorders Pain	5.6% 5/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Skin and subcutaneous tissue disorders Pain of skin	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Skin and subcutaneous tissue disorders Periorbital edema	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Peripheral motor neuropathy	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Peripheral sensory neuropathy	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Eye disorders Photophobia	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Investigations Platelet count decreased	21.1% 19/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Skin and subcutaneous tissue disorders Pruritus	6.7% 6/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Skin and subcutaneous tissue disorders Rash maculo-papular	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Skin and subcutaneous tissue disorders Scalp pain	4.4% 4/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Skin and subcutaneous tissue disorders Skin hyperpigmentation	24.4% 22/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Respiratory, thoracic and mediastinal disorders Sore throat	30.0% 27/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Gastrointestinal disorders Stomach pain	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Gastrointestinal disorders Vomiting	56.7% 51/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Investigations Weight loss	35.6% 32/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Investigations White blood cell decreased	35.6% 32/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Ear and labyrinth disorders Tinnitus	3.3% 3/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Endocrine disorders Precocious puberty	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Endocrine disorders Adrenal insufficiency	11.1% 10/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Endocrine disorders Delayed puberty	3.3% 3/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Endocrine disorders Hyperthyroidism	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Endocrine disorders Hypothyroidism	17.8% 16/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Eye disorders Blurred vision	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Eye disorders Cataract	7.8% 7/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
General disorders Fever	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Injury, poisoning and procedural complications Spinal fracture	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Investigations Blood gonadotrophin abnormal	4.4% 4/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Investigations Blood prolactin abnormal	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Investigations Growth hormone abnormal	27.8% 25/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Investigations Weight gain	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Metabolism and nutrition disorders Hypomagnesemia	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Metabolism and nutrition disorders Obesity	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Musculoskeletal and connective tissue disorders Kyphosis	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Musculoskeletal and connective tissue disorders Osteoporosis	3.3% 3/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Musculoskeletal and connective tissue disorders Scoliosis	7.8% 7/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Acoustic nerve disorder NOS	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Amnesia	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Ataxia	7.8% 7/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Central nervous system necrosis	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Cognitive disturbance	37.8% 34/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Concentration impairment	2.2% 2/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Dysarthria	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders IVth nerve disorder	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Leukoencephalopathy	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Memory impairment	4.4% 4/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Nystagmus	4.4% 4/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Paresthesia	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Seizure	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Nervous system disorders Tremor	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Renal and urinary disorders Cystitis noninfective	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Renal and urinary disorders Urinary frequency	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Reproductive system and breast disorders Irregular menstruation	6.7% 6/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Respiratory, thoracic and mediastinal disorders Voice alteration	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).
Vascular disorders Hypotension	1.1% 1/90 • Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment) All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. All patients were assessed for acute toxicity on a weekly basis during CSI. Grading of acute toxicity was done per the CTEP (Cancer Therapy Evaluation Program) Active Version of CTCAE (Common Terminology Criteria for Adverse Events).

Additional Information

Torunn Yock, MD

Massachusetts General, Hospital

Phone: 6177262000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place