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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 : February 13, 2020
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I - WBRT Arm II - SRS
Hide 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
Arm/Group Title Arm I - WBRT Arm II - SRS Total
Hide 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
Hide 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
96 98 194
1.Primary Outcome
Title Cognitive Deterioration Free Survival Post-radiation in Patients Who Received SRS Compared to Patients Who Received WBRT
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I - WBRT Arm II - SRS
Hide 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)
Hide 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
Hide Description [Not Specified]
Time Frame Up to 5 years post radiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I - WBRT Arm II - SRS
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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]
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
Hide 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   --/--      --/--    
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Paul D. Brown, M.D.
Organization: Mayo Clinic
Phone: (713) 563-2415
EMail: brown.paul@mayo.edu
Layout table for additonal information
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: February 13, 2020