Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery

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ClinicalTrials.gov Identifier: NCT01372774

Recruitment Status : Completed

First Posted : June 14, 2011

Results First Posted : July 26, 2018

Last Update Posted : September 16, 2022

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Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Alliance for Clinical Trials in Oncology

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Cognitive/Functional Effects Metastatic Cancer Neurotoxicity Radiation Toxicity Unspecified Adult Solid Tumor, Protocol Specific
Interventions	Radiation: stereotactic radiosurgery Radiation: whole-brain radiation therapy
Enrollment	194

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Arm I - WBRT	Arm II - SRS
Arm/Group Description	Patients undergo whole brain radiot...	Patients undergo stereotactic radio...
Arm/Group Description	Patients undergo whole brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization. whole-brain radiation therapy: Undergo radiotherapy (RT)	Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization. stereotactic radiosurgery: Undergo RT
Period Title: Overall Study
Started	96	98
Completed	92	93
Not Completed	4	5
Reason Not Completed
Withdrawal prior to treatment	4	5

Baseline Characteristics

Arm/Group Title		Arm I - WBRT	Arm II - SRS	Total
Arm/Group Description		Patients undergo whole brain radiot...	Patients undergo stereotactic radio...	Total of all reporting groups
Arm/Group Description		Patients undergo whole brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization. whole-brain radiation therapy: Undergo radiotherapy (RT)	Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization. stereotactic radiosurgery: Undergo RT	Total of all reporting groups
Overall Number of Baseline Participants		96	98	194
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All patients were included in baseline analysis
Age, Continuous Median (Inter-Quartile Range) Unit of measure: Years
	Number Analyzed	96 participants	98 participants	194 participants
		62 (54 to 68)	61 (54 to 66)	61 (54 to 68)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	96 participants	98 participants	194 participants
	Female	46 47.9%	52 53.1%	98 50.5%
	Male	50 52.1%	46 46.9%	96 49.5%
Region of Enrollment Measure Type: Number Unit of measure: Participants
North America	Number Analyzed	96 participants	98 participants	194 participants
North America		96	98	194

Outcome Measures

1.Primary Outcome


Title	Cognitive Deterioration Free Survival Post-radiation in Patients Who Received SRS Compared to Patients Who Received WBRT
Description	To determine in patients with one to four brain metastases whether the...
Description	To determine in patients with one to four brain metastases whether there is less nuerocognitive progression post-randomization in patients who receive SRS to the surgical bed compared to patients who receive WBRT. Neurocognitive progression is defined as a drop of at least one stanard deviation from baseline in one of the six neurocognitive tests at post-randomization evaluation.
Time Frame	from baseline up to 5 years post radiation

Outcome Measure Data

Analysis Population Description

All enrolled patients were included in the analysis of this outcome. This includes the 9 patients that did not receive treatment.


Arm/Group Title	Arm I - WBRT	Arm II - SRS
Arm/Group Description:	Patients undergo whole brain radiot...	Patients undergo stereotactic radio...
Arm/Group Description:	Patients undergo whole brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization. whole-brain radiation therapy: Undergo radiotherapy (RT)	Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization. stereotactic radiosurgery: Undergo RT
Overall Number of Participants Analyzed	96	98
Median (95% Confidence Interval) Unit of Measure: Months
	3.0 (2.86 to 3.25)	3.7 (3.45 to 5.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I - WBRT, Arm II - SRS
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.47
	Confidence Interval	(2-Sided) 95% 0.35 to 0.63
	Estimation Comments	[Not Specified]

2.Primary Outcome


Title	Overall Survival
Description	To determine in patients with one to four brain metastases whether the...
Description	To determine in patients with one to four brain metastases whether there is improved overall survival in patients who receive SRS to the surgical bed compared to patients who receive WBRT. Overall survival is defined as the time from randomization to death from any cause.
Time Frame	from baseline up to 5 years post radiation

Outcome Measure Data

Analysis Population Description

All enrolled patients were included in the analysis of this outcome. This includes the 9 patients that did not receive treatment.


Arm/Group Title	Arm I - WBRT	Arm II - SRS
Arm/Group Description:	Patients undergo whole brain radiot...	Patients undergo stereotactic radio...
Arm/Group Description:	Patients undergo whole brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization. whole-brain radiation therapy: Undergo radiotherapy (RT)	Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization. stereotactic radiosurgery: Undergo RT
Overall Number of Participants Analyzed	96	98
Median (95% Confidence Interval) Unit of Measure: months
	11.6 (9.9 to 18)	12.2 (9.7 to 16.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I - WBRT, Arm II - SRS
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.70
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95% 0.76 to 1.50
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Local Control of the Surgical Bed
Description	Local control of the surgical bed means that tumor did not recur at th...
Description	Local control of the surgical bed means that tumor did not recur at the unresected metastases treated with stereotactic radiosurgery, SRS, or whole brain radiotherapy, WBRT. Intercranial Brain Control Rates estimated via 1-Cumulatice Incidence Rate from Competing Risk survival analysis of time to the specific recurrence type. Deaths without recurrence are censored at time of death.
Time Frame	Up to 6 months post radiation

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm I - WBRT	Arm II - SRS
Arm/Group Description:	Patients undergo whole brain radiot...	Patients undergo stereotactic radio...
Arm/Group Description:	Patients undergo whole brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.	Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.
Overall Number of Participants Analyzed	96	98
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of patients
	87.1 (80.5 to 94.2)	80.4 (72.8 to 88.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I - WBRT, Arm II - SRS
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.00068
	Comments	Intracranial Brain Control Rates estimated via 1-Cumulative Incidence Rate from Competing Risk survival analysis of time to the specific recurrence type. Deaths without recurrence are censored at time of death.
	Method	Gray's K-sample
	Comments	[Not Specified]

4.Secondary Outcome


Title	Time to CNS Failure in These Patients
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to 5 years post radiation

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm I - WBRT	Arm II - SRS
Arm/Group Description:	Patients undergo whole brain radiot...	Patients undergo stereotactic radio...
Arm/Group Description:	Patients undergo whole brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.	Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.
Overall Number of Participants Analyzed	96	98
Median (95% Confidence Interval) Unit of Measure: Months
	27.5 ^[1] (14.85 to NA)	6.4 (5.16 to 8.90)

[1]

Not Reached

5.Secondary Outcome


Title	Change in Quality-of-life at 6 Months
Description	Clinically significant change in quality of life is defined as ten-poi...
Description	Clinically significant change in quality of life is defined as ten-point change on QOL scores (transformed to a 0 to 100 scale). As measured by the overall score from the FACT-Br. An improvement is defined as a change greater than or equal ten points.
Time Frame	Up to 6 months post randomization

Outcome Measure Data

Analysis Population Description

Only patients with baseline and 6 month QOL assessment scores were included in this analysis.


Arm/Group Title	Arm I - WBRT	Arm II - SRS
Arm/Group Description:	Patients undergo whole brain radiot...	Patients undergo stereotactic radio...
Arm/Group Description:	Patients undergo whole brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.	Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.
Overall Number of Participants Analyzed	64	65
Measure Type: Number Unit of Measure: participants
Improvement	4	6
Stable	24	33
Decline	17	12
Missing	19	14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I - WBRT, Arm II - SRS
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.31
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Adverse Events

Time Frame	Up to 2 years
Adverse Event Reporting Description	CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 4.0. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm)

Arm/Group Title	Arm I - WBRT		Arm II - SRS
Arm/Group Description	whole-brain radiation therapy: Unde...		stereotactic radiosurgery: Undergo ...
Arm/Group Description	whole-brain radiation therapy: Undergo radiotherapy (RT)		stereotactic radiosurgery: Undergo RT
All-Cause Mortality
	Arm I - WBRT		Arm II - SRS
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Arm I - WBRT		Arm II - SRS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/92 (15.22%)		19/93 (20.43%)
Blood and lymphatic system disorders
Anemia ^† 1	1/92 (1.09%)	2	0/93 (0.00%)	0
Leukocytosis ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Eye disorders
Optic nerve disorder ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Gastrointestinal disorders
Nausea ^† 1	3/92 (3.26%)	4	0/93 (0.00%)	0
Vomiting ^† 1	2/92 (2.17%)	4	0/93 (0.00%)	0
General disorders
Death NOS ^† 1	1/92 (1.09%)	1	1/93 (1.08%)	1
Fatigue ^† 1	2/92 (2.17%)	2	0/93 (0.00%)	0
Localized edema ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Multi-organ failure ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Sudden death NOS ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Infections and infestations
Esophageal infection ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Meningitis ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Otitis media ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Pancreas infection ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Sepsis ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Wound infection ^† 1	1/92 (1.09%)	1	1/93 (1.08%)	1
Injury, poisoning and procedural complications
Wound dehiscence ^† 1	1/92 (1.09%)	2	0/93 (0.00%)	0
Investigations
Alanine aminotransferase increased ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Alkaline phosphatase increased ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Aspartate aminotransferase increased ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Blood bilirubin increased ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Creatinine increased ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Hemoglobin increased ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Lipase increased ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Lymphocyte count decreased ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Serum amylase increased ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Metabolism and nutrition disorders
Anorexia ^† 1	2/92 (2.17%)	2	0/93 (0.00%)	0
Dehydration ^† 1	4/92 (4.35%)	4	0/93 (0.00%)	0
Hyperglycemia ^† 1	2/92 (2.17%)	4	0/93 (0.00%)	0
Hypoalbuminemia ^† 1	2/92 (2.17%)	4	0/93 (0.00%)	0
Hypocalcemia ^† 1	1/92 (1.09%)	2	0/93 (0.00%)	0
Hypokalemia ^† 1	2/92 (2.17%)	2	0/93 (0.00%)	0
Hyponatremia ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Hypophosphatemia ^† 1	2/92 (2.17%)	3	0/93 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back pain ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Generalized muscle weakness ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify ^† 1	2/92 (2.17%)	2	1/93 (1.08%)	1
Nervous system disorders
Central nervous system necrosis ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Cognitive disturbance ^† 1	1/92 (1.09%)	1	1/93 (1.08%)	1
Depressed level of consciousness ^† 1	2/92 (2.17%)	2	0/93 (0.00%)	0
Intracranial hemorrhage ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Leukoencephalopathy ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Nervous system disorders - Other, specify ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Peripheral motor neuropathy ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Seizure ^† 1	2/92 (2.17%)	3	2/93 (2.15%)	4
Stroke ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Psychiatric disorders
Agitation ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Confusion ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Renal and urinary disorders
Acute kidney injury ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Proteinuria ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Urinary retention ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Respiratory, thoracic and mediastinal disorders
Aspiration ^† 1	2/92 (2.17%)	2	0/93 (0.00%)	0
Bronchopulmonary hemorrhage ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Dyspnea ^† 1	0/92 (0.00%)	0	3/93 (3.23%)	3
Hypoxia ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Pulmonary edema ^† 1	0/92 (0.00%)	0	2/93 (2.15%)	2
Respiratory failure ^† 1	3/92 (3.26%)	5	1/93 (1.08%)	1
Skin and subcutaneous tissue disorders
Alopecia ^† 1	1/92 (1.09%)	1	3/93 (3.23%)	3
Vascular disorders
Thromboembolic event ^† 1	1/92 (1.09%)	2	2/93 (2.15%)	2
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 12
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm I - WBRT		Arm II - SRS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	74/92 (80.43%)		64/93 (68.82%)
Blood and lymphatic system disorders
Anemia ^† 1	2/92 (2.17%)	4	1/93 (1.08%)	2
Blood and lymphatic system disorders - Other, specify ^† 1	1/92 (1.09%)	3	0/93 (0.00%)	0
Cardiac disorders
Heart failure ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Sinus tachycardia ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
External ear inflammation ^† 1	6/92 (6.52%)	12	0/93 (0.00%)	0
Hearing impaired ^† 1	21/92 (22.83%)	62	15/93 (16.13%)	46
Middle ear inflammation ^† 1	2/92 (2.17%)	2	0/93 (0.00%)	0
Tinnitus ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Eye disorders
Blurred vision ^† 1	2/92 (2.17%)	5	0/93 (0.00%)	0
Eye disorders - Other, specify ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Optic nerve disorder ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Retinopathy ^† 1	0/92 (0.00%)	0	2/93 (2.15%)	2
Gastrointestinal disorders
Colitis ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Constipation ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Dental caries ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Dyspepsia ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Dysphagia ^† 1	1/92 (1.09%)	1	4/93 (4.30%)	7
Fecal incontinence ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Gastrointestinal disorders - Other, specify ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Mucositis oral ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Nausea ^† 1	36/92 (39.13%)	65	22/93 (23.66%)	31
Oral pain ^† 1	1/92 (1.09%)	1	1/93 (1.08%)	1
Vomiting ^† 1	21/92 (22.83%)	24	9/93 (9.68%)	13
General disorders
Death NOS ^† 1	2/92 (2.17%)	2	0/93 (0.00%)	0
Fatigue ^† 1	20/92 (21.74%)	31	10/93 (10.75%)	23
Gait disturbance ^† 1	1/92 (1.09%)	2	0/93 (0.00%)	0
General disorders and administration site conditions - Other, specify ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Malaise ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Multi-organ failure ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Non-cardiac chest pain ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Pain ^† 1	2/92 (2.17%)	2	1/93 (1.08%)	1
Infections and infestations
Mucosal infection ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Otitis externa ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Otitis media ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Sepsis ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Tooth infection ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Upper respiratory infection ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Injury, poisoning and procedural complications
Dermatitis radiation ^† 1	14/92 (15.22%)	19	3/93 (3.23%)	3
Fall ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Wound complication ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Wound dehiscence ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Investigations
Aspartate aminotransferase increased ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Creatinine increased ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Ejection fraction decreased ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Lymphocyte count decreased ^† 1	2/92 (2.17%)	3	2/93 (2.15%)	2
Neutrophil count decreased ^† 1	0/92 (0.00%)	0	2/93 (2.15%)	2
Platelet count decreased ^† 1	1/92 (1.09%)	1	1/93 (1.08%)	1
Weight gain ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Weight loss ^† 1	2/92 (2.17%)	5	1/93 (1.08%)	2
White blood cell decreased ^† 1	1/92 (1.09%)	1	1/93 (1.08%)	1
Metabolism and nutrition disorders
Anorexia ^† 1	5/92 (5.43%)	8	1/93 (1.08%)	1
Dehydration ^† 1	2/92 (2.17%)	2	0/93 (0.00%)	0
Hyperglycemia ^† 1	3/92 (3.26%)	3	0/93 (0.00%)	0
Hypoalbuminemia ^† 1	1/92 (1.09%)	2	1/93 (1.08%)	1
Hyponatremia ^† 1	1/92 (1.09%)	1	1/93 (1.08%)	1
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Back pain ^† 1	2/92 (2.17%)	4	1/93 (1.08%)	1
Bone pain ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Chest wall pain ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Generalized muscle weakness ^† 1	4/92 (4.35%)	7	2/93 (2.15%)	2
Muscle weakness lower limb ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Muscle weakness right-sided ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Myalgia ^† 1	1/92 (1.09%)	1	1/93 (1.08%)	1
Pain in extremity ^† 1	2/92 (2.17%)	2	2/93 (2.15%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify ^† 1	0/92 (0.00%)	0	3/93 (3.23%)	3
Nervous system disorders
Ataxia ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Central nervous system necrosis ^† 1	0/92 (0.00%)	0	6/93 (6.45%)	8
Cognitive disturbance ^† 1	27/92 (29.35%)	52	17/93 (18.28%)	26
Depressed level of consciousness ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Dizziness ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Dysarthria ^† 1	1/92 (1.09%)	1	1/93 (1.08%)	1
Dysgeusia ^† 1	2/92 (2.17%)	2	0/93 (0.00%)	0
Facial nerve disorder ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Headache ^† 1	4/92 (4.35%)	4	4/93 (4.30%)	5
Intracranial hemorrhage ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Ischemia cerebrovascular ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Memory impairment ^† 1	3/92 (3.26%)	3	0/93 (0.00%)	0
Meningismus ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Nervous system disorders - Other, specify ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Peripheral motor neuropathy ^† 1	10/92 (10.87%)	16	16/93 (17.20%)	23
Peripheral sensory neuropathy ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Reversible posterior leukoencephalopathy syndrome ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Seizure ^† 1	3/92 (3.26%)	3	6/93 (6.45%)	6
Tremor ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Psychiatric disorders
Confusion ^† 1	1/92 (1.09%)	1	1/93 (1.08%)	1
Depression ^† 1	1/92 (1.09%)	2	0/93 (0.00%)	0
Insomnia ^† 1	1/92 (1.09%)	2	0/93 (0.00%)	0
Renal and urinary disorders
Acute kidney injury ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Chronic kidney disease ^† 1	0/92 (0.00%)	0	1/93 (1.08%)	1
Urinary incontinence ^† 1	2/92 (2.17%)	2	0/93 (0.00%)	0
Reproductive system and breast disorders
Uterine hemorrhage ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	3/92 (3.26%)	4	1/93 (1.08%)	2
Dyspnea ^† 1	2/92 (2.17%)	2	4/93 (4.30%)	5
Hoarseness ^† 1	1/92 (1.09%)	1	1/93 (1.08%)	3
Nasal congestion ^† 1	1/92 (1.09%)	2	0/93 (0.00%)	0
Pharyngolaryngeal pain ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Pneumonitis ^† 1	2/92 (2.17%)	2	1/93 (1.08%)	1
Productive cough ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Respiratory failure ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Respiratory, thoracic and mediastinal disorders - Other, specify ^† 1	1/92 (1.09%)	2	0/93 (0.00%)	0
Sore throat ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Skin and subcutaneous tissue disorders
Alopecia ^† 1	49/92 (53.26%)	119	28/93 (30.11%)	57
Dry skin ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Rash acneiform ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Skin and subcutaneous tissue disorders - Other, specify ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Vascular disorders
Hypotension ^† 1	1/92 (1.09%)	1	0/93 (0.00%)	0
Thromboembolic event ^† 1	4/92 (4.35%)	4	2/93 (2.15%)	2
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 12

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Paul D. Brown, M.D.
Organization:	Mayo Clinic
Phone:	(713) 563-2415
EMail:	brown.paul@mayo.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Palmer JD, Klamer BG, Ballman KV, Brown PD, Cerhan JH, Anderson SK, Carrero XW, Whitton AC, Greenspoon J, Parney IF, Laack NNI, Ashman JB, Bahary JP, Hadjipanayis CG, Urbanic JJ, Barker FG 2nd, Farace E, Khuntia D, Giannini C, Buckner JC, Galanis E, Roberge D. Association of Long-term Outcomes With Stereotactic Radiosurgery vs Whole-Brain Radiotherapy for Resected Brain Metastasis: A Secondary Analysis of The N107C/CEC.3 (Alliance for Clinical Trials in Oncology/Canadian Cancer Trials Group) Randomized Clinical Trial. JAMA Oncol. 2022 Dec 1;8(12):1809-1815. doi: 10.1001/jamaoncol.2022.5049.

Brown PD, Ballman KV, Cerhan JH, Anderson SK, Carrero XW, Whitton AC, Greenspoon J, Parney IF, Laack NNI, Ashman JB, Bahary JP, Hadjipanayis CG, Urbanic JJ, Barker FG 2nd, Farace E, Khuntia D, Giannini C, Buckner JC, Galanis E, Roberge D. Postoperative stereotactic radiosurgery compared with whole brain radiotherapy for resected metastatic brain disease (NCCTG N107C/CEC.3): a multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. 2017 Aug;18(8):1049-1060. doi: 10.1016/S1470-2045(17)30441-2. Epub 2017 Jul 4.

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Responsible Party:	Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:	NCT01372774
Other Study ID Numbers:	N107C NCCTG-N107C CDR0000701474 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-2011-02676 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted:	June 11, 2011
First Posted:	June 14, 2011
Results First Submitted:	September 27, 2017
Results First Posted:	July 26, 2018
Last Update Posted:	September 16, 2022

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