Trial Outcomes & Findings for Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma (NCT NCT00895622)

Last Updated: 2023-09-08

Results Overview

Progression was determined by central review of magnetic resonance imaging (MRI) exams and is defined as an increase in measurable tumor of greater than 20% in any diameter, or as new nodular enhancement in patients with no measurable tumor on initial postoperative imaging. In the absence of neurologic progression (NP), suspected imaging progression of less than 5 mm (maximum diameter) must be confirmed on two successive follow-up MRI studies, a minimum of 3 months apart. NP is defined as a new or progressive neurologic deficit attributed to the meningioma, with or without measurable meningioma growth. Progression-free survival (PFS) rates are estimated using the binomial method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

244 participants

Primary outcome timeframe

From registration to 3 years

Results posted on

2023-09-08

Participant Flow

Two hundred forty-four patients registered for the first step registration which consisted of central pathology review confirmation of histology. One hundred seventy-eight continued on to the second step registration.

Participant milestones

Participant milestones
Measure	Low Risk No treatment given	Intermidiate Risk 54 Gy radiotherapy	High Risk 60 Gy radiotherapy
Overall Study STARTED	65	56	57
Overall Study COMPLETED	60	52	53
Overall Study NOT COMPLETED	5	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Low Risk No treatment given	Intermidiate Risk 54 Gy radiotherapy	High Risk 60 Gy radiotherapy
Overall Study Protocol Violation	5	4	4

Baseline Characteristics

Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Risk n=60 Participants No treatment given	Intermidiate Risk n=52 Participants 54 Gy radiotherapy	High Risk n=53 Participants 60 Gy radiotherapy	Total n=165 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	53 years n=7 Participants	62 years n=5 Participants	56 years n=4 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	32 Participants n=7 Participants	28 Participants n=5 Participants	108 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	20 Participants n=7 Participants	25 Participants n=5 Participants	57 Participants n=4 Participants

PRIMARY outcome

Timeframe: From registration to 3 years

Population: Eligible patients who started study treatment and evaluable for 3-year progression-free survival

Outcome measures

Outcome measures
Measure	Low Risk n=51 Participants No treatment given	Intermidiate Risk n=48 Participants 54 Gy radiotherapy	High Risk n=51 Participants 60 Gy radiotherapy
Progression-free Survival Rate at 3 Years	92.2 percentage of participants Interval 81.1 to 97.8	93.7 percentage of participants Interval 82.8 to 98.7	58.8 percentage of participants Interval 44.2 to 72.4

SECONDARY outcome

Timeframe: From start of radiation to 90 days.

Population: Eligible patients who started study treatment with acute AE assessed. Low risk patients are not reported since they did not receive any study treatment.

Grades 2-5 neurology, ocular/visual, dermatologic/skin \[excluding alopecia\] categories, individually and combined for acute adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 where the attribution is related to treatment as definite, probable, possible, or unknown. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Outcome measures

Outcome measures
Measure	Low Risk n=46 Participants No treatment given	Intermidiate Risk n=53 Participants 54 Gy radiotherapy	High Risk 60 Gy radiotherapy
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Dermatology/Skin · Grade 5	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Dermatology/Skin · None Grade 2-5	45 Participants	51 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Neurology · Grade 2	4 Participants	3 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Neurology · Grade 3	0 Participants	2 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Neurology · Grade 4	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Neurology · Grade 5	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Neurology · None Grade 2-5	42 Participants	48 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Ocular/visual · Grade 2	1 Participants	0 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Ocular/visual · Grade 3	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Ocular/visual · Grade 4	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Ocular/visual · Grade 5	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Ocular/visual · None Grade 2-5	45 Participants	53 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Dermatology/Skin · Grade 2	1 Participants	2 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Dermatology/Skin · Grade 3	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Dermatology/Skin · Grade 4	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Groups combined · Grade 2	5 Participants	4 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Groups combined · Grade 3	0 Participants	2 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Groups combined · Grade 4	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Groups combined · Grade 5	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Groups combined · None Grade 2-5	41 Participants	47 Participants	—

SECONDARY outcome

Timeframe: Ninety-one days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 6.3 years.

Population: Eligible patients who started study treatment with acute AE assessed. Low risk patients are not reported since they did not receive any study treatment.

Outcome measures

Outcome measures
Measure	Low Risk n=51 Participants No treatment given	Intermidiate Risk n=51 Participants 54 Gy radiotherapy	High Risk 60 Gy radiotherapy
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Groups combined · Grade 2	13 Participants	11 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Neurology · Grade 2	12 Participants	11 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Neurology · Grade 3	0 Participants	3 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Neurology · Grade 4	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Neurology · Grade 5	0 Participants	1 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Neurology · None Grade 2-5	39 Participants	36 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Ocular/visual · Grade 2	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Ocular/visual · Grade 3	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Ocular/visual · Grade 4	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Ocular/visual · Grade 5	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Ocular/visual · None Grade 2-5	51 Participants	51 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Dermatology/Skin · Grade 2	1 Participants	0 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Dermatology/Skin · Grade 3	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Dermatology/Skin · Grade 4	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Dermatology/Skin · Grade 5	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Dermatology/Skin · None Grade 2-5	50 Participants	51 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Groups combined · Grade 3	0 Participants	3 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Groups combined · Grade 4	0 Participants	0 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Groups combined · Grade 5	0 Participants	1 Participants	—
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia] Groups combined · None Grade 2-5	38 Participants	36 Participants	—

SECONDARY outcome

Timeframe: From registration to 3 years

Population: Eligible patients who started study treatment

Overall survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

Outcome measures

Outcome measures
Measure	Low Risk n=52 Participants No treatment given	Intermidiate Risk n=48 Participants 54 Gy radiotherapy	High Risk n=51 Participants 60 Gy radiotherapy
Overall Survival Rate at 3 Years	98.1 percentage of participants Interval 89.7 to 100.0	95.8 percentage of participants Interval 85.8 to 99.5	78.4 percentage of participants Interval 64.7 to 88.7

SECONDARY outcome

Timeframe: From registration to 3 years

Population: Eligible patients who started study treatment and evaluable for 3-year progression-free survival

Progression was determined by central review of MRI exams and is defined as an increase in measurable tumor of greater than 20% in any diameter, or as new nodular enhancement in patients with no measurable tumor on initial postoperative imaging. In the absence of neurologic progression (NP), suspected imaging progression of less than 5 mm (maximum diameter) must be confirmed on two successive follow-up MRI studies, a minimum of 3 months apart. NP is defined as a new or progressive neurologic deficit attributed to the meningioma, with or without measurable meningioma growth. Progression-free survival time is defined as time from registration to the date of progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Low Risk n=60 Participants No treatment given	Intermidiate Risk n=52 Participants 54 Gy radiotherapy	High Risk n=53 Participants 60 Gy radiotherapy
Progression-free Survival Rate at 3 Years (Kaplan-Meier Method)	91.4 percentage of participants Interval 84.2 to 98.6	93.9 percentage of participants Interval 87.2 to 100.0	59.2 percentage of participants Interval 45.7 to 72.6

SECONDARY outcome

Timeframe: Baseline, at time of first progression, and at 3 years

Population: Eligible participants who started study treatment, had a centrally reviewed MRI at the given time, and whose MRI was evaluable for the given feature

MRI's were centrally reviewed by the study neuroradiology co-chairs for presence of edema, homogeneous enhancement, calcification, hyperostosis, and brain invasion. Data is presented for all risk groups combined, with time points presented in each column. Neither risk groups nor time points are compared.

Outcome measures

Outcome measures
Measure	Low Risk n=148 Participants No treatment given	Intermidiate Risk n=23 Participants 54 Gy radiotherapy	High Risk n=79 Participants 60 Gy radiotherapy
Number of Participants Determined to Have MRI Imaging Features as Assessed by Central Neuroradiology Review at Diagnosis, at Progression, and at 3 Years Edema	76 Participants	13 Participants	15 Participants
Number of Participants Determined to Have MRI Imaging Features as Assessed by Central Neuroradiology Review at Diagnosis, at Progression, and at 3 Years Homogeneous Enhancement	88 Participants	9 Participants	14 Participants
Number of Participants Determined to Have MRI Imaging Features as Assessed by Central Neuroradiology Review at Diagnosis, at Progression, and at 3 Years Calcification	6 Participants	0 Participants	1 Participants
Number of Participants Determined to Have MRI Imaging Features as Assessed by Central Neuroradiology Review at Diagnosis, at Progression, and at 3 Years Hyperostosis	17 Participants	0 Participants	1 Participants
Number of Participants Determined to Have MRI Imaging Features as Assessed by Central Neuroradiology Review at Diagnosis, at Progression, and at 3 Years Brain Invasion	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, at time of first progression, and at 3 years

Population: Eligible participants who started study treatment, had a centrally reviewed MRI at the given time, and whose MRI was evaluable for tumor dimension.

MRI's were centrally reviewed by the study neuroradiology co-chairs. Data is presented for all risk groups combined, with time points presented in each column. Neither risk groups nor time points are compared.

Outcome measures

Outcome measures
Measure	Low Risk n=148 Participants No treatment given	Intermidiate Risk n=21 Participants 54 Gy radiotherapy	High Risk n=28 Participants 60 Gy radiotherapy
Greatest Single Dimension From MRI as Assessed by Central Neuroradiology Review at Diagnosis, at Progression, and at 3 Years	42.7 milimeters Interval 4.2 to 144.4	34.7 milimeters Interval 14.0 to 104.0	29.0 milimeters Interval 7.5 to 129.9

SECONDARY outcome

Timeframe: After treatment delivery

Population: Eligible participants who started treatment and were centrally reviewed

The principle investigator performed a radiotherapy quality assurance (QA) review.

Outcome measures

Outcome measures
Measure	Low Risk n=44 Participants No treatment given	Intermidiate Risk n=46 Participants 54 Gy radiotherapy	High Risk 60 Gy radiotherapy
Adherence to Protocol-specific Target and Normal Tissue Radiotherapy Parameters Per protocol	36 Participants	39 Participants	—
Adherence to Protocol-specific Target and Normal Tissue Radiotherapy Parameters Acceptable variation	4 Participants	5 Participants	—
Adherence to Protocol-specific Target and Normal Tissue Radiotherapy Parameters Unacceptable deviation	2 Participants	1 Participants	—
Adherence to Protocol-specific Target and Normal Tissue Radiotherapy Parameters Not evaluable	2 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Baseline

Population: Eligible patients with central and site reviews

A pathology review was conducted both by the institution and centrally, with three possible choices for grade / subtype: World Health Organization (WHO) Grade I / benign; WHO grade II / atypical; WHO grade III / anaplastic. Data is presented for all risk groups combined.

Outcome measures

Outcome measures
Measure	Low Risk n=76 Participants No treatment given	Intermidiate Risk n=71 Participants 54 Gy radiotherapy	High Risk n=25 Participants 60 Gy radiotherapy
Concordance Between Central and Parent Institution Histopathologic Grading/Subtyping Site Review: Benign	74 Participants	9 Participants	1 Participants
Concordance Between Central and Parent Institution Histopathologic Grading/Subtyping Site Review: Atypical	2 Participants	60 Participants	8 Participants
Concordance Between Central and Parent Institution Histopathologic Grading/Subtyping Site Review: Anaplastic	0 Participants	2 Participants	16 Participants

SECONDARY outcome

Timeframe: From registration to 3 years

Population: The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG Oncology tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From registration to 3 years

Population: The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.

Outcome measures

Outcome data not reported

Adverse Events

Low Risk

Serious events: 0 serious events

Other events: 22 other events

Deaths: 22 deaths

Intermidiate Risk

Serious events: 1 serious events

Other events: 47 other events

Deaths: 47 deaths

High Risk

Serious events: 5 serious events

Other events: 47 other events

Deaths: 47 deaths

Serious adverse events

Serious adverse events
Measure	Low Risk n=60 participants at risk No treatment given	Intermidiate Risk n=52 participants at risk 54 Gy radiotherapy	High Risk n=53 participants at risk 60 Gy radiotherapy
General disorders Gait abnormal	0.00% 0/60 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/52 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.9% 1/53 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain [other]	0.00% 0/60 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/52 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.9% 1/53 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Soft tissue infection [with normal or Grade 1-2 ANC]	0.00% 0/60 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/52 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.9% 1/53 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Central nervous system necrosis	0.00% 0/60 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.9% 1/52 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.9% 1/53 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Neurological disorder NOS	0.00% 0/60 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/52 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.9% 1/53 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/60 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/52 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.9% 1/53 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Seizure	0.00% 0/60 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/52 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.8% 2/53 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Tremor	0.00% 0/60 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/52 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.9% 1/53 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hypertension	0.00% 0/60 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/52 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.9% 1/53 Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Other adverse events

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER