Trial Outcomes & Findings for Proton/Photon Rt - Benign Meningiomas(P92-13) (NCT NCT02947984)

NCT ID: NCT02947984

Last Updated: 2017-06-14

Results Overview

The number of participants surviving at the given time point. Progression free survival (PFS) is measured from the starting date of radiation therapy and analyzed by intention to treat. PFS is measured until the earlier, date of death or development of radiologic progression, and is otherwise censored at the last follow-up for progression-free patients still alive.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 44 participants
• Primary outcome timeframe: 5, 10, 15 years
• Results posted on: 2017-06-14

Participant Flow

Participant milestones

Measure	Standard Treatment Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.	Higher Dose Treatment 63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
Overall Study STARTED	22	22
Overall Study COMPLETED	22	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proton/Photon Rt - Benign Meningiomas(P92-13)

Baseline characteristics by cohort

Measure	Standard Treatment n=22 Participants Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.	Higher Dose Treatment n=22 Participants 63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.	Total n=44 Participants Total of all reporting groups
Age, Continuous	61 years n=5 Participants	50.5 years n=7 Participants	55.5 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	22 participants n=7 Participants	44 participants n=5 Participants
Tumor Location Sphenoid wing	7 Tumors n=5 Participants	8 Tumors n=7 Participants	15 Tumors n=5 Participants
Tumor Location Cavernous sinus	3 Tumors n=5 Participants	8 Tumors n=7 Participants	11 Tumors n=5 Participants
Tumor Location Sella/Parasella	6 Tumors n=5 Participants	2 Tumors n=7 Participants	8 Tumors n=5 Participants
Tumor Location Cerebellar pontine angle	3 Tumors n=5 Participants	1 Tumors n=7 Participants	4 Tumors n=5 Participants
Tumor Location Clival/prepontine space	3 Tumors n=5 Participants	1 Tumors n=7 Participants	4 Tumors n=5 Participants
Tumor Location Olfactory groove	1 Tumors n=5 Participants	0 Tumors n=7 Participants	1 Tumors n=5 Participants
Tumor Location Optic canal	0 Tumors n=5 Participants	1 Tumors n=7 Participants	1 Tumors n=5 Participants
Tumor Location Tentorium	0 Tumors n=5 Participants	1 Tumors n=7 Participants	1 Tumors n=5 Participants
Smoking Status Smoker	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Smoking Status Non-smoker	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Smoking Status Unknown	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Co-morbidities Hypertension	3 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants
Co-morbidities Diabetes mellitus	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants
Co-morbidities Hyperlipidemia	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Co-morbidities Coronary artery disease	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Co-morbidities One or more of the above	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Radiation Indication Sub-Total Resection, postoperative	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Radiation Indication Recurrent Disease	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Gross Tumor Volume	39.7 Cubic Centimeters n=5 Participants	13.2 Cubic Centimeters n=7 Participants	26.5 Cubic Centimeters n=5 Participants
Clinical Target Volume	49 Cubic Centimeters n=5 Participants	28 Cubic Centimeters n=7 Participants	38.5 Cubic Centimeters n=5 Participants

PRIMARY outcome

Timeframe: 5, 10, 15 years

Population: Progression free survival in the entire cohort and by radiation indication sub-groups

The number of participants surviving at the given time point. Progression free survival (PFS) is measured from the starting date of radiation therapy and analyzed by intention to treat. PFS is measured until the earlier, date of death or development of radiologic progression, and is otherwise censored at the last follow-up for progression-free patients still alive.

Outcome measures

Measure	Standard Treatment n=22 Participants Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.	Higher Dose Treatment n=22 Participants 63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
Progression Free Survival Recurrent Disease: 5 Years	82 percentage of participants surviving Interval 45.0 to 95.0	100 percentage of participants surviving confidence interval not defined because no deaths occurred
Progression Free Survival Entire Cohort: 5 Years	91 percentage of participants surviving Interval 68.0 to 98.0	91 percentage of participants surviving Interval 68.0 to 98.0
Progression Free Survival Entire Cohort: 10 Years	86 percentage of participants surviving Interval 62.0 to 95.0	81 percentage of participants surviving Interval 58.0 to 93.0
Progression Free Survival Entire Cohort: 15 Years	52 percentage of participants surviving Interval 28.0 to 72.0	70 percentage of participants surviving Interval 45.0 to 86.0
Progression Free Survival Subtotal Resection: 5 Years	100 percentage of participants surviving confidence interval not defined because no deaths occurred	83 percentage of participants surviving Interval 48.0 to 96.0
Progression Free Survival Subtotal Resection: 10 Years	91 percentage of participants surviving Interval 51.0 to 99.0	67 percentage of participants surviving Interval 34.0 to 86.0
Progression Free Survival Subtotal Resection: 15 Years	64 percentage of participants surviving Interval 30.0 to 85.0	57 percentage of participants surviving Interval 25.0 to 80.0
Progression Free Survival Recurrent Disease: 10 Years	82 percentage of participants surviving Interval 45.0 to 95.0	100 percentage of participants surviving confidence interval not defined because no deaths occurred
Progression Free Survival Recurrent Disease: 15 Years	65 percentage of participants surviving Interval 24.0 to 88.0	100 percentage of participants surviving confidence interval not defined because no deaths occurred

SECONDARY outcome

Timeframe: 90 Days

The number of participants that experienced the specified acute toxicities (any grade) as assessed by Radiation Therapy Oncology Acute Morbidity Scoring Criteria. Acute toxicities were assessed from the start of treatment through day 90 of treatment.

Outcome measures

Measure	Standard Treatment n=22 Participants Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.	Higher Dose Treatment n=22 Participants 63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
Acute Toxicities Syncope	1 participants	0 participants
Acute Toxicities Vision loss	2 participants	1 participants
Acute Toxicities Visual field deficit	1 participants	0 participants
Acute Toxicities Diplopia	2 participants	0 participants
Acute Toxicities Ptosis	0 participants	1 participants
Acute Toxicities Exophthalmos	1 participants	0 participants
Acute Toxicities Conjunctivitis	1 participants	2 participants
Acute Toxicities Eye, other	2 participants	5 participants
Acute Toxicities Hearing loss	1 participants	2 participants
Acute Toxicities Tinnitus	0 participants	1 participants
Acute Toxicities Olfactory alteration	1 participants	1 participants
Acute Toxicities Gustation alteration	3 participants	1 participants
Acute Toxicities Neuromotor deficit	1 participants	0 participants
Acute Toxicities Weakness	1 participants	0 participants
Acute Toxicities Facial numbness	2 participants	1 participants
Acute Toxicities Facial weakness	2 participants	2 participants
Acute Toxicities Ataxia	1 participants	0 participants
Acute Toxicities Seizure	1 participants	1 participants
Acute Toxicities Headache	3 participants	8 participants
Acute Toxicities Nausea	9 participants	8 participants
Acute Toxicities Dizziness	1 participants	1 participants
Acute Toxicities Vertigo	1 participants	4 participants
Acute Toxicities Depression	0 participants	3 participants
Acute Toxicities Neurocog deficit	1 participants	3 participants
Acute Toxicities Endocrine deficit	0 participants	1 participants
Acute Toxicities Skin changes	16 participants	18 participants
Acute Toxicities Alopecia	7 participants	11 participants
Acute Toxicities Fatigue	12 participants	10 participants

SECONDARY outcome

Timeframe: 5 Years

The number of participants that experienced the specified late toxicities (any grade) as assessed by Radiation Therapy Oncology Group Late Effects Scale.

Outcome measures

Measure	Standard Treatment n=22 Participants Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.	Higher Dose Treatment n=22 Participants 63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
Late Toxicities Neurocognative deficit	7 participants	6 participants
Late Toxicities Fall	0 participants	3 participants
Late Toxicities Dysarthria	1 participants	0 participants
Late Toxicities Headache	5 participants	3 participants
Late Toxicities Dizziness	1 participants	0 participants
Late Toxicities Vertigo	1 participants	1 participants
Late Toxicities Depression	0 participants	1 participants
Late Toxicities Endocrine deficit	7 participants	10 participants
Late Toxicities Osteoporosis	0 participants	1 participants
Late Toxicities Cerebral edema	1 participants	0 participants
Late Toxicities Brain atrophy	0 participants	1 participants
Late Toxicities Skin changes	1 participants	1 participants
Late Toxicities Alopecia	0 participants	2 participants
Late Toxicities Fatigue	4 participants	3 participants
Late Toxicities Vision loss	5 participants	2 participants
Late Toxicities Visual field deficit	5 participants	1 participants
Late Toxicities Diplopia	1 participants	3 participants
Late Toxicities Exophthalmos	0 participants	2 participants
Late Toxicities Eye, other	3 participants	2 participants
Late Toxicities Hearing loss	6 participants	4 participants
Late Toxicities Tinnitus	2 participants	3 participants
Late Toxicities Olfactory alteration	0 participants	2 participants
Late Toxicities Gustation alteration	0 participants	1 participants
Late Toxicities Dysphasia	0 participants	1 participants
Late Toxicities Neuromotor deficit	1 participants	0 participants
Late Toxicities Weakness	1 participants	2 participants
Late Toxicities Facial numbness	1 participants	4 participants
Late Toxicities Facial weakness	4 participants	2 participants
Late Toxicities Ataxia	2 participants	3 participants

SECONDARY outcome

Timeframe: 15 Years

Population: Failure rates are shown by dose group in the overall study population and by treatment indication subgroups.

The number of participants with local failure. Local failure is defined as radiologic progression seen on follow-up scans showing tumor margin(s) extending in any direction at least five mm beyond that seen on baseline scans.

Outcome measures

Measure	Standard Treatment n=22 Participants Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.	Higher Dose Treatment n=22 Participants 63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
Local Failure Rate Entire Cohort	3 participants	2 participants
Local Failure Rate Post-operative subgroup	0 participants	1 participants
Local Failure Rate Tumor recurrence subgroup	3 participants	1 participants

Adverse Events

Standard Treatment

Serious events: 6 serious events

Other events: 22 other events

Deaths: 14 deaths

Higher Dose Treatment

Serious events: 0 serious events

Other events: 22 other events

Deaths: 5 deaths

Serious adverse events

Measure	Standard Treatment n=22 participants at risk Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.	Higher Dose Treatment n=22 participants at risk 63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
Nervous system disorders Neuromotor deficit	9.1% 2/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Eye disorders Vision loss	9.1% 2/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Endocrine disorders Endocrine deficit	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
General disorders Cerebral edema	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.

Other adverse events

Measure	Standard Treatment n=22 participants at risk Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.	Higher Dose Treatment n=22 participants at risk 63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
Eye disorders Vision loss	22.7% 5/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	13.6% 3/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Eye disorders Visual field deficit	27.3% 6/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Eye disorders Diplopia	13.6% 3/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	13.6% 3/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Eye disorders Ptosis	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Eye disorders Exophthalmos	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	9.1% 2/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Eye disorders Conjunctivitis	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	9.1% 2/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Eye disorders Eye, other	22.7% 5/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	31.8% 7/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Ear and labyrinth disorders Hearing loss	31.8% 7/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	27.3% 6/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Ear and labyrinth disorders Tinnitus	9.1% 2/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	18.2% 4/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Respiratory, thoracic and mediastinal disorders Olfactory alteration	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	13.6% 3/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Gastrointestinal disorders Gustation alteration	13.6% 3/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	9.1% 2/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Gastrointestinal disorders Dysphasia	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Nervous system disorders Neuromotor deficit	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
General disorders Weakness	9.1% 2/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	9.1% 2/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Nervous system disorders Facial numbness	13.6% 3/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	22.7% 5/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Musculoskeletal and connective tissue disorders Facial weakness	27.3% 6/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	18.2% 4/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Nervous system disorders Ataxia	13.6% 3/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	13.6% 3/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
General disorders Fall	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	13.6% 3/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Nervous system disorders Seizure	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Nervous system disorders Dysarthria	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Nervous system disorders Headache	36.4% 8/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	50.0% 11/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Gastrointestinal disorders Nausea	40.9% 9/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	36.4% 8/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Nervous system disorders Dizziness	9.1% 2/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Ear and labyrinth disorders Vertigo	9.1% 2/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	22.7% 5/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Nervous system disorders Syncope	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Psychiatric disorders Depression	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	18.2% 4/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Nervous system disorders Neurocog deficit	36.4% 8/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	40.9% 9/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Endocrine disorders Endocrine deficit	27.3% 6/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	50.0% 11/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Nervous system disorders Cerebral edema	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Nervous system disorders Brain atrophy	0.00% 0/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	4.5% 1/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Skin and subcutaneous tissue disorders Skin changes	77.3% 17/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	86.4% 19/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
Skin and subcutaneous tissue disorders Alopecia	31.8% 7/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	59.1% 13/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.
General disorders Fatigue	72.7% 16/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.	59.1% 13/22 • 90 Days, 15 years Patients were assessed for adverse events with Radiation Therapy Oncology Group Common Toxicity Criteria. Patients were assessed weekly during the course of treatment. Post treatment, participants were evaluated for interval history and neurological function routinely at one month, every three months during the first year, four month intervals during the second year, twice yearly through year 5, and then yearly for the remainder of follow-up.

Additional Information

Nina Sanford, MD

Massachusetts General Hospital

Email: NSANFORD@PARTNERS.ORG

Results disclosure agreements

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