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Trial record 1 of 1 for:    NCCTG 0574
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Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

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ClinicalTrials.gov Identifier: NCT00377156
Recruitment Status : Completed
First Posted : September 15, 2006
Results First Posted : August 24, 2017
Last Update Posted : February 12, 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 Breast Cancer
Cognitive/Functional Effects
Lung Cancer
Metastatic Cancer
Prostate Cancer
Interventions Radiation: radiation therapy
Radiation: stereotactic radiosurgery
Enrollment 213
Recruitment Details At 34 institutions in North America, patients with 1 to 3 brain metastases were randomized to receive SRS or SRS plus WBRT between February 2002 and December 2013. 70 patients accrued by ACOSOG Z0300 were included in the power calculation and also included for this study.
Pre-assignment Details  
Arm/Group Title Arm I (SRS) Arm II (SRS+WBRT)
Hide Arm/Group Description Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.

Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter.>

> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS.

Period Title: Overall Study
Started 111 102
Completed 63 48
Not Completed 48 54
Reason Not Completed
Death             23             19
Withdrawal by Subject             16             24
Had follow-up <90 d             3             6
Cancellation             1             0
Refused testing             0             1
Ineligible             0             1
Disability or language problem             0             1
Other             5             2
Arm/Group Title Arm I (SRS) Arm II (SRS+WBRT) Total
Hide Arm/Group Description Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.

Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter.>

> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS.

Total of all reporting groups
Overall Number of Baseline Participants 111 102 213
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 102 participants 213 participants
59.8  (10.4) 61.4  (10.6) 60.6  (10.5)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 102 participants 213 participants
18 to 59
53
  47.7%
44
  43.1%
97
  45.5%
>= 60
58
  52.3%
58
  56.9%
116
  54.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 102 participants 213 participants
Female
57
  51.4%
47
  46.1%
104
  48.8%
Male
54
  48.6%
55
  53.9%
109
  51.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 111 participants 102 participants 213 participants
Canada 23 22 45
United States 88 80 168
1.Primary Outcome
Title Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months
Hide Description The primary endpoint was cognitive deterioration (progression), defined as a decline of greater than 1 SD from baseline on at least 1 of 7 cognitive tests (all tests are standardized based on published norms and transformed so that higher values represent improved cognition) at the 3-month post-SRS evaluation. The number of participants who experienced cognitive deterioration by 3 months is reported for each arm below. For primary analysis of the 3-month cognitive deterioration endpoint, the Fisher exact 2-group binomial test was used to compare the proportion of evaluable patients with 3-month cognitive deterioration between the 2 groups.
Time Frame 3 months post radiosurgery
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who died prior to the 3-month evaluation, who did not return for the 3-month evaluation or a subsequent evaluation, or who did not complete the required baseline tests were excluded from the analysis population for the primary end point.
Arm/Group Title Arm I (SRS) Arm II (SRS+WBRT)
Hide Arm/Group Description:
Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.

Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter.>

> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS.

Overall Number of Participants Analyzed 63 48
Measure Type: Count of Participants
Unit of Measure: Participants
40
  63.5%
44
  91.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (SRS), Arm II (SRS+WBRT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -28.2
Confidence Interval (2-Sided) 90%
-41.9 to -14.4
Estimation Comments Cognitive deterioration, the primary end point in evaluable patients at 3 months, was less frequent after Arm I than Arm II (40/63 [63.5%] vs 44/48 [91.7%],> respectively. The percent difference was -28.2%; 90% CI, -41.9% to -14.4%; P < .001).
2.Secondary Outcome
Title Number of Participants With Local and Distant Tumor Control up to 3 Months
Hide Description Number of Participants with Local and Distant Tumor Control up to 3 months is defined as....
Time Frame Up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (SRS) Arm II (SRS+WBRT)
Hide Arm/Group Description:
Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.

Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter.>

> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS.

Overall Number of Participants Analyzed 105 95
Measure Type: Count of Participants
Unit of Measure: Participants
79
  75.2%
89
  93.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (SRS), Arm II (SRS+WBRT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -18.4
Confidence Interval (2-Sided) 95%
-29.0 to -7.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Quality of Life, as Measured by Mean Change From Baseline [3 Month]
Hide Description Quality of Life was assessed using the Functional Assessment of Cancer Therapy-Brain, for which the range is from 0 to 200 and higher scores indicate better QOL. The Quality of Life (QOL) scores were transformed to a 0- to 100-point scale (with 100 being most favorable), in which a 10-point change was considered clinically significant. Intergroup changes in QOL scores were compared using a 2-sample t test.
Time Frame From Baseline to 3-Month Evaluation
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in the SRS and SRS+WBRT groups that had a baseline and 3-month QOL score were used in this analysis.
Arm/Group Title Arm I (SRS) Arm II (SRS+WBRT)
Hide Arm/Group Description:
Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.

Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter.>

>>

>

>> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS.

Overall Number of Participants Analyzed 65 50
Mean (95% Confidence Interval)
Unit of Measure: QOL score change from baseline points
-0.1
(-4.8 to 4.5)
-12
(-17.5 to -6.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (SRS), Arm II (SRS+WBRT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
4.8 to 19.0
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Long-Term Neurocognitive Status (Long-Term Cognitive Status), as Measured by Percentage of Long-term Survivors With Cognitive Deterioration at 12 Months
Hide Description Long-Term Neurocognitive Status > To ascertain in patients with one to three brain metastases whether there is better long-term neurocognitive status in patients who receive SRS alone (Arm A) compared to patients who receive SRS combined with WBRT (Arm B). Long-term survival status is defined as evaluable patients who survived for at least 12 months and had at least one cognitive assessment on or after 365 days.
Time Frame From baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who survived for at least 12 months and had at least one cognitive assessment on or after 365 days were included in this analysis.
Arm/Group Title Arm I (SRS) Arm II (SRS+WBRT)
Hide Arm/Group Description:
Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.

Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter.>

> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS.

Overall Number of Participants Analyzed 10 18
Measure Type: Number
Unit of Measure: percentage of participants
60 94.44
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (SRS), Arm II (SRS+WBRT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -34.4
Confidence Interval (2-Sided) 95%
-74.4 to 5.5
Estimation Comments The incidence of cognitive deterioration was less in Arm I than Arm II at 12 months (6/10 [60%] vs 17/18 [94.4%]. The percent difference was -34.4% (95% CI: -74.4% to 5.5%; P = .04)
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival, defined as the time from randomization until death due to any cause, was compared between the groups using stratified log-rank tests.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A survival comparison was performed on an intention-to-treat basis using the entire study population.
Arm/Group Title Arm I (SRS) Arm II (SRS+WBRT)
Hide Arm/Group Description:
Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.

Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter.>>

>> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS.

Overall Number of Participants Analyzed 111 102
Median (Full Range)
Unit of Measure: months
10.4
(0 to 62.5)
7.4
(0 to 60.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (SRS), Arm II (SRS+WBRT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.75 to 1.38
Estimation Comments [Not Specified]
Time Frame Up to 60 months from the start of treatment
Adverse Event Reporting Description All patients that began treatment and were assessed at least once for adverse events are included in this analysis. Adverse Events were collected at weeks 6 and 12 after radiation treatment, and at months 6, 9, 12, 16, 24, 36, 48, and 60 after radiation treatment.
 
Arm/Group Title Arm I (SRS) Arm II (SRS+WBRT)
Hide Arm/Group Description Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter. Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS.
All-Cause Mortality
Arm I (SRS) Arm II (SRS+WBRT)
Affected / at Risk (%) Affected / at Risk (%)
Total   5/68 (7.35%)      7/64 (10.94%)    
Hide Serious Adverse Events
Arm I (SRS) Arm II (SRS+WBRT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/68 (11.76%)      11/64 (17.19%)    
Ear and labyrinth disorders     
Hearing loss  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Gastrointestinal disorders     
Nausea  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Vomiting  1  1/68 (1.47%)  2 0/64 (0.00%)  0
General disorders     
Death  1  0/68 (0.00%)  0 3/64 (4.69%)  6
Disease progression  1  3/68 (4.41%)  6 2/64 (3.13%)  3
Fatigue  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Infections and infestations     
Bladder infection  1  1/68 (1.47%)  1 0/64 (0.00%)  0
Bronchitis  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Encephalitis infection  1  0/68 (0.00%)  0 1/64 (1.56%)  1
Investigations     
Alanine aminotransferase increased  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Alkaline phosphatase increased  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Aspartate aminotransferase increased  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Bilirubin increased  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Leukocyte count decreased  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Neutrophil count decreased  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Platelet count decreased  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Metabolism and nutrition disorders     
Hyperglycemia  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Hyponatremia  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Nervous system disorders     
Central nervous system necrosis  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Cognitive disturbance  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Encephalopathy  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Pleural effusion  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Pneumonitis  1  1/68 (1.47%)  2 1/64 (1.56%)  2
Vascular disorders     
Thrombosis  1  1/68 (1.47%)  2 0/64 (0.00%)  0
1
Term from vocabulary, MedDRA 9
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (SRS) Arm II (SRS+WBRT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/68 (66.18%)      53/64 (82.81%)    
Blood and lymphatic system disorders     
Hemoglobin decreased  1  5/68 (7.35%)  12 3/64 (4.69%)  8
Cardiac disorders     
Arrhythmia supraventricular  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Cardiopulmonary arrest  1  1/68 (1.47%)  2 1/64 (1.56%)  2
Left ventricular dysfunction  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Pericardial effusion  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Sinus tachycardia  1  1/68 (1.47%)  2 1/64 (1.56%)  2
Ear and labyrinth disorders     
External ear inflammation  1  2/68 (2.94%)  4 4/64 (6.25%)  8
Hearing loss  1  1/68 (1.47%)  2 11/64 (17.19%)  28
Tinnitus  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Eye disorders     
Diplopia  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Eye disorder  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Optic nerve disorder  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Retinopathy  1  1/68 (1.47%)  2 2/64 (3.13%)  4
Gastrointestinal disorders     
Abdominal distension  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Abdominal pain  1  2/68 (2.94%)  6 1/64 (1.56%)  2
Colonic perforation  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Diarrhea  1  2/68 (2.94%)  4 0/64 (0.00%)  0
Duodenal obstruction  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Dysphagia  1  0/68 (0.00%)  0 2/64 (3.13%)  4
Esophageal ulcer  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Esophagitis  1  1/68 (1.47%)  2 1/64 (1.56%)  2
Mucositis oral  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Nausea  1  21/68 (30.88%)  62 26/64 (40.63%)  108
Small intestinal obstruction  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Vomiting  1  11/68 (16.18%)  28 14/64 (21.88%)  52
General disorders     
Chest pain  1  2/68 (2.94%)  4 0/64 (0.00%)  0
Edema limbs  1  4/68 (5.88%)  10 0/64 (0.00%)  0
Fatigue  1  8/68 (11.76%)  22 9/64 (14.06%)  30
Gait abnormal  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Localized edema  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Pain  1  0/68 (0.00%)  0 4/64 (6.25%)  10
Hepatobiliary disorders     
Hepatic failure  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Immune system disorders     
Hypersensitivity  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Infections and infestations     
Gingival infection  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Infection  1  1/68 (1.47%)  2 1/64 (1.56%)  2
Pancreas infection  1  1/68 (1.47%)  4 0/64 (0.00%)  0
Pneumonia  1  3/68 (4.41%)  6 1/64 (1.56%)  4
Skin infection  1  2/68 (2.94%)  4 0/64 (0.00%)  0
Injury, poisoning and procedural complications     
Dermatitis radiation  1  5/68 (7.35%)  12 11/64 (17.19%)  26
Vascular access complication  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Investigations     
Alanine aminotransferase increased  1  0/68 (0.00%)  0 2/64 (3.13%)  4
Alkaline phosphatase increased  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Amylase increased  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Aspartate aminotransferase increased  1  2/68 (2.94%)  4 2/64 (3.13%)  4
Bilirubin increased  1  1/68 (1.47%)  2 1/64 (1.56%)  2
Coagulopathy  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Creatinine increased  1  0/68 (0.00%)  0 1/64 (1.56%)  2
INR increased  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Leukocyte count decreased  1  0/68 (0.00%)  0 2/64 (3.13%)  8
Lipase increased  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Lymphocyte count decreased  1  2/68 (2.94%)  8 2/64 (3.13%)  8
Neutrophil count decreased  1  1/68 (1.47%)  2 2/64 (3.13%)  8
Platelet count decreased  1  2/68 (2.94%)  4 3/64 (4.69%)  8
Weight gain  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Weight loss  1  2/68 (2.94%)  4 1/64 (1.56%)  2
Metabolism and nutrition disorders     
Acidosis  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Anorexia  1  2/68 (2.94%)  4 5/64 (7.81%)  12
Blood bicarbonate decreased  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Dehydration  1  0/68 (0.00%)  0 5/64 (7.81%)  12
Hyperglycemia  1  2/68 (2.94%)  6 0/64 (0.00%)  0
Hypermagnesemia  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Hypoalbuminemia  1  1/68 (1.47%)  2 1/64 (1.56%)  2
Hypocalcemia  1  1/68 (1.47%)  4 1/64 (1.56%)  2
Hypokalemia  1  1/68 (1.47%)  2 1/64 (1.56%)  2
Hypomagnesemia  1  1/68 (1.47%)  2 1/64 (1.56%)  2
Hyponatremia  1  1/68 (1.47%)  2 1/64 (1.56%)  2
Hypophosphatemia  1  1/68 (1.47%)  2 1/64 (1.56%)  2
Musculoskeletal and connective tissue disorders     
Back pain  1  3/68 (4.41%)  10 1/64 (1.56%)  2
Bone pain  1  2/68 (2.94%)  4 0/64 (0.00%)  0
Chest wall pain  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Muscle weakness  1  0/68 (0.00%)  0 2/64 (3.13%)  8
Muscle weakness left-sided  1  0/68 (0.00%)  0 1/64 (1.56%)  4
Muscle weakness lower limb  1  3/68 (4.41%)  5 0/64 (0.00%)  0
Muscle weakness upper limb  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Myalgia  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Pain in extremity  1  1/68 (1.47%)  2 1/64 (1.56%)  2
Nervous system disorders     
Central nervous system necrosis  1  4/68 (5.88%)  12 3/64 (4.69%)  10
Cognitive disturbance  1  14/68 (20.59%)  36 13/64 (20.31%)  42
Depressed level of consciousness  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Dizziness  1  1/68 (1.47%)  2 3/64 (4.69%)  6
Encephalopathy  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Headache  1  5/68 (7.35%)  12 4/64 (6.25%)  12
Neurological disorder NOS  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Peripheral motor neuropathy  1  16/68 (23.53%)  51 13/64 (20.31%)  40
Peripheral sensory neuropathy  1  1/68 (1.47%)  2 1/64 (1.56%)  2
Seizure  1  4/68 (5.88%)  10 1/64 (1.56%)  2
Syncope  1  0/68 (0.00%)  0 2/64 (3.13%)  4
Tremor  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Psychiatric disorders     
Agitation  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Confusion  1  1/68 (1.47%)  2 2/64 (3.13%)  4
Insomnia  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Renal and urinary disorders     
Renal failure  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Dyspnea  1  8/68 (11.76%)  17 6/64 (9.38%)  20
Hiccough  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Hypoxia  1  2/68 (2.94%)  4 2/64 (3.13%)  4
Pleural effusion  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Pleural hemorrhage  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Pneumonitis  1  0/68 (0.00%)  0 1/64 (1.56%)  4
Pneumothorax  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Respiratory disorder  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  23/68 (33.82%)  105 40/64 (62.50%)  162
Hand-and-foot syndrome  1  0/68 (0.00%)  0 1/64 (1.56%)  2
Pain of skin  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Pruritus  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Rash desquamating  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Skin disorder  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Vascular disorders     
Hematoma  1  1/68 (1.47%)  2 0/64 (0.00%)  0
Hypertension  1  1/68 (1.47%)  4 0/64 (0.00%)  0
Hypotension  1  0/68 (0.00%)  0 3/64 (4.69%)  6
Thrombosis  1  4/68 (5.88%)  8 1/64 (1.56%)  2
Vascular disorder  1  1/68 (1.47%)  2 0/64 (0.00%)  0
1
Term from vocabulary, MedDRA 9
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul Brown, M.D.
Organization: Mayo Clinic
Phone: 507-538-0948
EMail: Brown.Paul@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00377156    
Other Study ID Numbers: N0574
NCCTG-N0574
ACOSOG-N0574
CDR0000499633 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2009-00653 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted: September 13, 2006
First Posted: September 15, 2006
Results First Submitted: February 27, 2017
Results First Posted: August 24, 2017
Last Update Posted: February 12, 2020