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Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00096265
Recruitment Status : Terminated
First Posted : November 9, 2004
Results First Posted : April 16, 2013
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Malignant Neoplasm in the Brain
Recurrent Non-Small Cell Lung Carcinoma
Stage IV Non-Small Cell Lung Cancer AJCC v7
Interventions Radiation: 3-Dimensional Conformal Radiation Therapy
Drug: Erlotinib Hydrochloride
Radiation: Stereotactic Radiosurgery
Drug: Temozolomide
Enrollment 126
Recruitment Details  
Pre-assignment Details  
Arm/Group Title WBRT + SRS Temozolomide + WBRT + SRS Erlotinib + WBRT + SRS
Hide Arm/Group Description Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery. Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Period Title: Overall Study
Started 45 40 41
Completed 44 [1] 40 41
Not Completed 1 0 0
Reason Not Completed
Ineligible             1             0             0
[1]
Subjects contributing data to the primary analysis are considered to have completed the study.
Arm/Group Title WBRT + SRS Temozolomide + WBRT + SRS Erlotinib + WBRT + SRS Total
Hide Arm/Group Description Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery. Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months. Total of all reporting groups
Overall Number of Baseline Participants 45 40 41 126
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants 40 participants 41 participants 126 participants
63
(42 to 89)
63
(39 to 83)
61
(46 to 85)
63
(39 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 40 participants 41 participants 126 participants
Female
22
  48.9%
18
  45.0%
18
  43.9%
58
  46.0%
Male
23
  51.1%
22
  55.0%
23
  56.1%
68
  54.0%
1.Primary Outcome
Title Overall Survival
Hide Description Survival time is defined as time from randomization to date of death from any cause and estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact.
Time Frame From randomization to date of death or last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients.
Arm/Group Title WBRT + SRS Temozolomide + WBRT + SRS Erlotinib + WBRT + SRS
Hide Arm/Group Description:
Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Overall Number of Participants Analyzed 44 40 41
Median (95% Confidence Interval)
Unit of Measure: months
13.4
(6.5 to 20.8)
6.3
(3.4 to 10.1)
6.1
(3.6 to 12.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WBRT + SRS, Temozolomide + WBRT + SRS
Comments 120 patients per arm required to detect a 33% reduction in hazard rate corresponding to improvement in MST of 5.9 (null hypothesis) to 8.9 months with a one-sided type I error rate of 0.025 and 85% power.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments One-sided
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.43
Confidence Interval (2-Sided) 95%
0.89 to 2.31
Estimation Comments WBRT + SRS is the denominator of the hazard ratio.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection WBRT + SRS, Erlotinib + WBRT + SRS
Comments 120 patients per arm required to detect a 33% reduction in hazard rate corresponding to improvement in MST of 5.9 (null hypothesis) to 8.9 months with a one-sided type I error rate of 0.025 and 85% power.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments One-sided
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
0.92 to 2.36
Estimation Comments WBRT + SRS is the denominator of the hazard ratio.
2.Secondary Outcome
Title Rate of CNS Progression (One Year)
Hide Description CNS progression is defined as any increase in perpendicular bi-dimensional tumor area for any of the 1-3 tracked brain metastases, by any amount, or the appearance of any new brain metastasis on a follow-up MRI (SRS planning scan will not be used to evaluate CNS progression). For lesions smaller than 1 cm in maximum diameter, a maximum increase of 50% in perpendicular bi-dimensional treatment area is necessary to score as progression. This caveat is included to account for potential variability in measurement, which is most susceptible to proportionate errors at smaller sizes. For greater than 1 cm lesions, the definition uses a 25% rule for change. Rates of CNS progression estimated by the cumulative incidence method, with death treated as a competing risk.
Time Frame From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients
Arm/Group Title WBRT + SRS Temozolomide + WBRT + SRS Erlotinib + WBRT + SRS
Hide Arm/Group Description:
Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Overall Number of Participants Analyzed 44 40 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.1
(19.8 to 48.4)
47.4
(31.0 to 63.8)
27.4
(13.2 to 41.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WBRT + SRS, Temozolomide + WBRT + SRS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method Gray's test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Temozolomide + WBRT + SRS, Erlotinib + WBRT + SRS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Gray's test
Comments [Not Specified]
3.Secondary Outcome
Title Quality-adjusted Survival as Measured by EuroQol 5-dimension Instrument
Hide Description Quality-adjusted life years (QALY) incorporate the societal-based utilities of health states into expected life years for a health condition. The QALY model is QALY(h,y) where h is a health state and y is the years of life. Higher quality-adjusted life year values represent a better outcome. A patient's health state will be determined from the index score of the EQ-5D-5L patient questionnaire.The EQ-5D-5L is a 2-part self-assessment questionnaire, a 5-item index score and a visual analogue scale, but only the index score is used for quality-adjusted survival. The index score has 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state).
Time Frame From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with any follow-up EQ-5D
Arm/Group Title WBRT + SRS Temozolomide + WBRT + SRS Erlotinib + WBRT + SRS
Hide Arm/Group Description:
Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Overall Number of Participants Analyzed 24 19 18
Mean (Standard Deviation)
Unit of Measure: Quality-adjusted life years
16.9  (9.6) 15.9  (12.0) 14.4  (12.5)
4.Secondary Outcome
Title Change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score at 3 Months
Hide Description The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a 19-item self-report instrument designed to measure multidimensional quality of life in patients with brain cancer. It is to be administered with the FACT-General. There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score, which ranges from 0 to 76. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-Br including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicates better QOL. A change of 5 points will be considered a minimal clinically meaningful change. Change from baseline at three months (3 month score - baseline score) will be categorized as improvement if increased, stable if no change, or deterioration if decreased.
Time Frame From randomization to three months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with both baseline and 3 month data
Arm/Group Title WBRT + SRS Temozolomide + WBRT + SRS Erlotinib + WBRT + SRS
Hide Arm/Group Description:
Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Overall Number of Participants Analyzed 26 16 17
Measure Type: Count of Participants
Unit of Measure: Participants
Deterioration/Decrease
12
  46.2%
10
  62.5%
11
  64.7%
Stable
8
  30.8%
2
  12.5%
6
  35.3%
Improvement/Increase
6
  23.1%
4
  25.0%
1
   5.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WBRT + SRS, Temozolomide + WBRT + SRS
Comments With 70 patients per arm, a 0.05 level chi-square test would have 80% power to distinguish between two groups when the proportions in the three categories are as follows for standard vs. experimental arm, respectively: 25% vs. 50% improvement, 55% vs. 40% stable, and 20% vs. 10% deterioration, or any distribution that corresponds to an effect size, Δ² = Σ(π2j-π1j)2/[2(π2j-π1j)], of 0.0702.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection WBRT + SRS, Erlotinib + WBRT + SRS
Comments With 70 patients per arm, a 0.05 level chi-square test would have 80% power to distinguish between two groups when the proportions in the three categories are as follows for standard vs. experimental arm, respectively: 25% vs. 50% improvement, 55% vs. 40% stable, and 20% vs. 10% deterioration, or any distribution that corresponds to an effect size, Δ² = Σ(π2j-π1j)2/[2(π2j-π1j)], of 0.0702.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Change in Performance Status at Six Months
Hide Description Compared between two treatment arms using a two-group chi-squared test. Zubrod score will be collected at baseline and follow-up. The Zubrod performance score runs from 0 to 5, with 0 denoting perfect health and 5 death. Change from baseline is calculated as 6-month value - baseline value. Patients with a baseline score who have died by six months will be included in the analysis with a score of 5 at six months.
Time Frame From randomization to six months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with baseline and 6 month data
Arm/Group Title WBRT + SRS Temozolomide + WBRT + SRS Erlotinib + WBRT + SRS
Hide Arm/Group Description:
Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Overall Number of Participants Analyzed 40 35 35
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement (decrease)
0
   0.0%
1
   2.9%
3
   8.6%
Stable (no change)
19
  47.5%
4
  11.4%
2
   5.7%
Deterioration (increase)
21
  52.5%
30
  85.7%
30
  85.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WBRT + SRS, Temozolomide + WBRT + SRS
Comments 108 with three month performance status data, per arm, would result in a 0.050 level chi-square test with 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/[2(π2j-π1j)], of 0.0586.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection WBRT + SRS, Erlotinib + WBRT + SRS
Comments 108 cases with three month performance status data, per arm, would result in a 0.050 level chi-square test with 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/[2(π2j-π1j)], of 0.0586.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Change in Steroid Dependence at Six Months
Hide Description Daily steroid dose will be collected at baseline and follow-up, as one of the following: 0-4 mg, >4 to ≤ 8 mg, >8 to ≤12 mg, and >12 mg. Change from baseline at six months will be evaluated to have decreased, remained stable, or increased, based on these categories.
Time Frame From randomization to six months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with both baseline and 6 month steroid dose
Arm/Group Title WBRT + SRS Temozolomide + WBRT + SRS Erlotinib + WBRT + SRS
Hide Arm/Group Description:
Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Overall Number of Participants Analyzed 26 18 17
Measure Type: Count of Participants
Unit of Measure: Participants
Decrease
12
  46.2%
10
  55.6%
10
  58.8%
Stable
10
  38.5%
4
  22.2%
6
  35.3%
Increase
4
  15.4%
4
  22.2%
1
   5.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WBRT + SRS, Temozolomide + WBRT + SRS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Assuming the survival rate of the standard arm (MST = 5.9 months), then 49% of patients were expected to be alive at six months. Assuming steroid data would be available for 90% of these patients, results in a projection of 52 cases/arm with steroid data at 6 months. With this sample size, a two-sided 0.050 alpha test will have 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/[2(π2j-π1j)], of 0.1217.
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection WBRT + SRS, Erlotinib + WBRT + SRS
Comments Assuming the survival rate of the standard arm (MST = 5.9 months), then 49% of patients were expected to be alive at six months. Assuming steroid data would be available for 90% of these patients, results in a projection of 52 cases/arm with steroid data at 6 months. With this sample size, a two-sided 0.050 alpha test will have 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/[2(π2j-π1j)], of 0.1217.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Cause of Death (Neurologic vs Other)
Hide Description Patients were considered to have died neurologic deaths (coded as "Brain Metastases") if they had stable systemic disease and progressive neurologic disease consisting of expanding intracranial masses, CNS hemorrhages, hydrocephalus resulting in herniation or fulminant meningeal carcinomatosis.
Time Frame From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who died
Arm/Group Title WBRT + SRS Temozolomide + WBRT + SRS Erlotinib + WBRT + SRS
Hide Arm/Group Description:
Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Overall Number of Participants Analyzed 35 34 36
Measure Type: Count of Participants
Unit of Measure: Participants
Neuroligic death
6
  17.1%
5
  14.7%
7
  19.4%
Other
29
  82.9%
29
  85.3%
29
  80.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WBRT + SRS, Temozolomide + WBRT + SRS
Comments A two group chi-square test with a 0.05 two-sided significance level would have 89% power to detect the difference between a proportion of 0.50 and a proportion of 0.30, or equivalently, of 0.70, when the sample size in each group is 120.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection WBRT + SRS, Erlotinib + WBRT + SRS
Comments A two group chi-square test with a 0.05 two-sided significance level would have 89% power to detect the difference between a proportion of 0.50 and a proportion of 0.30, or equivalently, of 0.70, when the sample size in each group is 120.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Per the protocol, toxicity data was collected via CTC 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
 
Arm/Group Title WBRT+SRS Temozolomide+WBRT+SRS Erlotinib+WBRT+SRS
Hide Arm/Group Description Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery. [Data is reported for eligible patients with adverse event information, which is 44 patients.] Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. [Data is reported for eligible patients with adverse event information, which is 39 patients.] Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months. [Data is reported for eligible patients with adverse event information, which is 41 patients.]
All-Cause Mortality
WBRT+SRS Temozolomide+WBRT+SRS Erlotinib+WBRT+SRS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
WBRT+SRS Temozolomide+WBRT+SRS Erlotinib+WBRT+SRS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/44 (22.73%)   22/39 (56.41%)   12/41 (29.27%) 
Blood and lymphatic system disorders       
Anemia * 1  2/44 (4.55%)  5/39 (12.82%)  4/41 (9.76%) 
Blood and lymphatic system disorders - Other * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Hemolysis * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Cardiac disorders       
Cardiac disorders - Other * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Myocardial infarction * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Gastrointestinal disorders       
Abdominal pain * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Lower gastrointestinal hemorrhage * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Nausea * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Rectal hemorrhage * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Upper gastrointestinal hemorrhage * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Vomiting * 1  0/44 (0.00%)  1/39 (2.56%)  1/41 (2.44%) 
General disorders       
Death NOS * 1  3/44 (6.82%)  2/39 (5.13%)  2/41 (4.88%) 
Edema limbs * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Fatigue * 1  0/44 (0.00%)  0/39 (0.00%)  2/41 (4.88%) 
Fever * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
General disorders and administration site conditions - Other * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Non-cardiac chest pain * 1  1/44 (2.27%)  1/39 (2.56%)  0/41 (0.00%) 
Sudden death NOS * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Infections and infestations       
Infections and infestations - Other * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Lung infection * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Injury, poisoning and procedural complications       
Dermatitis radiation * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Fracture * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Investigations       
Creatinine increased * 1  0/44 (0.00%)  1/39 (2.56%)  1/41 (2.44%) 
GGT increased * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
INR increased * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Investigations - Other * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Platelet count decreased * 1  0/44 (0.00%)  4/39 (10.26%)  2/41 (4.88%) 
Weight loss * 1  0/44 (0.00%)  1/39 (2.56%)  2/41 (4.88%) 
White blood cell decreased * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Metabolism and nutrition disorders       
Anorexia * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Dehydration * 1  0/44 (0.00%)  1/39 (2.56%)  1/41 (2.44%) 
Hyperglycemia * 1  0/44 (0.00%)  2/39 (5.13%)  1/41 (2.44%) 
Hyperkalemia * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Hypocalcemia * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Hypokalemia * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Hypomagnesemia * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Hyponatremia * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Musculoskeletal and connective tissue disorders       
Chest wall pain * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Generalized muscle weakness * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Muscle weakness lower limb * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Nervous system disorders       
Ataxia * 1  0/44 (0.00%)  1/39 (2.56%)  1/41 (2.44%) 
Central nervous system necrosis * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Cognitive disturbance * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Dizziness * 1  1/44 (2.27%)  1/39 (2.56%)  0/41 (0.00%) 
Dysphasia * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Encephalopathy * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Headache * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Intracranial hemorrhage * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Ischemia cerebrovascular * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Leukoencephalopathy * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Peripheral motor neuropathy * 1  0/44 (0.00%)  3/39 (7.69%)  0/41 (0.00%) 
Peripheral sensory neuropathy * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Seizure * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Psychiatric disorders       
Confusion * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Renal and urinary disorders       
Renal and urinary disorders - Other * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Atelectasis * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Bronchopulmonary hemorrhage * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Bronchospasm * 1  1/44 (2.27%)  1/39 (2.56%)  0/41 (0.00%) 
Cough * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Dyspnea * 1  0/44 (0.00%)  1/39 (2.56%)  2/41 (4.88%) 
Hypoxia * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Pleural effusion * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Pneumonitis * 1  0/44 (0.00%)  1/39 (2.56%)  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders - Other * 1  2/44 (4.55%)  0/39 (0.00%)  0/41 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Rash maculo-papular * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Vascular disorders       
Hypotension * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Thromboembolic event * 1  0/44 (0.00%)  3/39 (7.69%)  3/41 (7.32%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
WBRT+SRS Temozolomide+WBRT+SRS Erlotinib+WBRT+SRS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/44 (63.64%)   32/39 (82.05%)   34/41 (82.93%) 
Blood and lymphatic system disorders       
Anemia * 1  7/44 (15.91%)  12/39 (30.77%)  11/41 (26.83%) 
Blood and lymphatic system disorders - Other * 1  0/44 (0.00%)  3/39 (7.69%)  0/41 (0.00%) 
Disseminated intravascular coagulation * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Cardiac disorders       
Atrial fibrillation * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Cardiac disorders - Other * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Myocardial infarction * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Sinus tachycardia * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Ear and labyrinth disorders       
Ear and labyrinth disorders - Other * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Ear pain * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
External ear inflammation * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
External ear pain * 1  0/44 (0.00%)  2/39 (5.13%)  1/41 (2.44%) 
Hearing impaired * 1  1/44 (2.27%)  2/39 (5.13%)  2/41 (4.88%) 
Middle ear inflammation * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Endocrine disorders       
Cushingoid * 1  2/44 (4.55%)  1/39 (2.56%)  0/41 (0.00%) 
Eye disorders       
Blurred vision * 1  1/44 (2.27%)  3/39 (7.69%)  1/41 (2.44%) 
Conjunctivitis * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Dry eye * 1  0/44 (0.00%)  1/39 (2.56%)  3/41 (7.32%) 
Extraocular muscle paresis * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Eye disorders - Other * 1  1/44 (2.27%)  1/39 (2.56%)  3/41 (7.32%) 
Eye pain * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Optic nerve disorder * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Photophobia * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Watering eyes * 1  1/44 (2.27%)  0/39 (0.00%)  1/41 (2.44%) 
Gastrointestinal disorders       
Abdominal distension * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Abdominal pain * 1  1/44 (2.27%)  3/39 (7.69%)  1/41 (2.44%) 
Constipation * 1  3/44 (6.82%)  10/39 (25.64%)  10/41 (24.39%) 
Dental caries * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Diarrhea * 1  3/44 (6.82%)  3/39 (7.69%)  14/41 (34.15%) 
Dry mouth * 1  0/44 (0.00%)  2/39 (5.13%)  3/41 (7.32%) 
Dyspepsia * 1  0/44 (0.00%)  4/39 (10.26%)  1/41 (2.44%) 
Dysphagia * 1  2/44 (4.55%)  2/39 (5.13%)  3/41 (7.32%) 
Fecal incontinence * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Flatulence * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Gastrointestinal disorders - Other * 1  1/44 (2.27%)  0/39 (0.00%)  1/41 (2.44%) 
Mucositis oral * 1  0/44 (0.00%)  4/39 (10.26%)  2/41 (4.88%) 
Nausea * 1  7/44 (15.91%)  13/39 (33.33%)  15/41 (36.59%) 
Oral hemorrhage * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Small intestinal obstruction * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Stomach pain * 1  0/44 (0.00%)  1/39 (2.56%)  2/41 (4.88%) 
Toothache * 1  0/44 (0.00%)  1/39 (2.56%)  1/41 (2.44%) 
Vomiting * 1  6/44 (13.64%)  7/39 (17.95%)  8/41 (19.51%) 
General disorders       
Chills * 1  1/44 (2.27%)  0/39 (0.00%)  1/41 (2.44%) 
Edema face * 1  2/44 (4.55%)  0/39 (0.00%)  1/41 (2.44%) 
Edema limbs * 1  2/44 (4.55%)  5/39 (12.82%)  2/41 (4.88%) 
Fatigue * 1  20/44 (45.45%)  24/39 (61.54%)  22/41 (53.66%) 
Fever * 1  0/44 (0.00%)  1/39 (2.56%)  2/41 (4.88%) 
Gait disturbance * 1  1/44 (2.27%)  3/39 (7.69%)  0/41 (0.00%) 
General disorders and administration site conditions - Other * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Irritability * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Non-cardiac chest pain * 1  2/44 (4.55%)  1/39 (2.56%)  5/41 (12.20%) 
Pain * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Immune system disorders       
Immune system disorders - Other * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Infections and infestations       
Anorectal infection * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Bladder infection * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Enterocolitis infectious * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Infections and infestations - Other * 1  1/44 (2.27%)  5/39 (12.82%)  5/41 (12.20%) 
Lung infection * 1  2/44 (4.55%)  0/39 (0.00%)  0/41 (0.00%) 
Mucosal infection * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Otitis externa * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Otitis media * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Salivary gland infection * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Upper respiratory infection * 1  0/44 (0.00%)  1/39 (2.56%)  2/41 (4.88%) 
Urinary tract infection * 1  0/44 (0.00%)  1/39 (2.56%)  1/41 (2.44%) 
Injury, poisoning and procedural complications       
Bruising * 1  1/44 (2.27%)  1/39 (2.56%)  0/41 (0.00%) 
Dermatitis radiation * 1  2/44 (4.55%)  10/39 (25.64%)  4/41 (9.76%) 
Fracture * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Radiation recall reaction (dermatologic) * 1  0/44 (0.00%)  1/39 (2.56%)  2/41 (4.88%) 
Investigations       
Activated partial thromboplastin time prolonged * 1  1/44 (2.27%)  1/39 (2.56%)  2/41 (4.88%) 
Alanine aminotransferase increased * 1  1/44 (2.27%)  4/39 (10.26%)  8/41 (19.51%) 
Alkaline phosphatase increased * 1  3/44 (6.82%)  4/39 (10.26%)  6/41 (14.63%) 
Aspartate aminotransferase increased * 1  1/44 (2.27%)  3/39 (7.69%)  10/41 (24.39%) 
Blood bilirubin increased * 1  0/44 (0.00%)  0/39 (0.00%)  4/41 (9.76%) 
Creatinine increased * 1  0/44 (0.00%)  1/39 (2.56%)  3/41 (7.32%) 
Fibrinogen decreased * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
GGT increased * 1  3/44 (6.82%)  1/39 (2.56%)  3/41 (7.32%) 
INR increased * 1  0/44 (0.00%)  4/39 (10.26%)  3/41 (7.32%) 
Investigations - Other * 1  0/44 (0.00%)  3/39 (7.69%)  2/41 (4.88%) 
Lymphocyte count decreased * 1  1/44 (2.27%)  2/39 (5.13%)  3/41 (7.32%) 
Neutrophil count decreased * 1  1/44 (2.27%)  2/39 (5.13%)  5/41 (12.20%) 
Platelet count decreased * 1  2/44 (4.55%)  7/39 (17.95%)  4/41 (9.76%) 
Weight gain * 1  2/44 (4.55%)  1/39 (2.56%)  0/41 (0.00%) 
Weight loss * 1  3/44 (6.82%)  8/39 (20.51%)  11/41 (26.83%) 
White blood cell decreased * 1  2/44 (4.55%)  3/39 (7.69%)  4/41 (9.76%) 
Metabolism and nutrition disorders       
Acidosis * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Anorexia * 1  7/44 (15.91%)  13/39 (33.33%)  18/41 (43.90%) 
Dehydration * 1  0/44 (0.00%)  1/39 (2.56%)  5/41 (12.20%) 
Hyperglycemia * 1  4/44 (9.09%)  7/39 (17.95%)  7/41 (17.07%) 
Hyperkalemia * 1  0/44 (0.00%)  4/39 (10.26%)  0/41 (0.00%) 
Hypermagnesemia * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Hypernatremia * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Hypoalbuminemia * 1  3/44 (6.82%)  5/39 (12.82%)  8/41 (19.51%) 
Hypocalcemia * 1  4/44 (9.09%)  6/39 (15.38%)  6/41 (14.63%) 
Hypoglycemia * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Hypokalemia * 1  2/44 (4.55%)  4/39 (10.26%)  6/41 (14.63%) 
Hypomagnesemia * 1  1/44 (2.27%)  0/39 (0.00%)  2/41 (4.88%) 
Hyponatremia * 1  5/44 (11.36%)  4/39 (10.26%)  8/41 (19.51%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/44 (0.00%)  2/39 (5.13%)  2/41 (4.88%) 
Back pain * 1  3/44 (6.82%)  5/39 (12.82%)  3/41 (7.32%) 
Bone pain * 1  1/44 (2.27%)  3/39 (7.69%)  2/41 (4.88%) 
Chest wall pain * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Generalized muscle weakness * 1  3/44 (6.82%)  2/39 (5.13%)  5/41 (12.20%) 
Muscle weakness left-sided * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Muscle weakness lower limb * 1  3/44 (6.82%)  2/39 (5.13%)  3/41 (7.32%) 
Muscle weakness right-sided * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Myalgia * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Neck pain * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Osteoporosis * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Pain in extremity * 1  1/44 (2.27%)  1/39 (2.56%)  2/41 (4.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumor pain * 1  1/44 (2.27%)  0/39 (0.00%)  1/41 (2.44%) 
Nervous system disorders       
Arachnoiditis * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Ataxia * 1  3/44 (6.82%)  4/39 (10.26%)  4/41 (9.76%) 
Central nervous system necrosis * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Cognitive disturbance * 1  1/44 (2.27%)  2/39 (5.13%)  2/41 (4.88%) 
Depressed level of consciousness * 1  2/44 (4.55%)  0/39 (0.00%)  2/41 (4.88%) 
Dizziness * 1  4/44 (9.09%)  4/39 (10.26%)  6/41 (14.63%) 
Dysgeusia * 1  2/44 (4.55%)  4/39 (10.26%)  8/41 (19.51%) 
Dysphasia * 1  2/44 (4.55%)  2/39 (5.13%)  2/41 (4.88%) 
Facial nerve disorder * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Headache * 1  8/44 (18.18%)  8/39 (20.51%)  7/41 (17.07%) 
Hydrocephalus * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Intracranial hemorrhage * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Ischemia cerebrovascular * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Memory impairment * 1  5/44 (11.36%)  2/39 (5.13%)  6/41 (14.63%) 
Myelitis * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Nervous system disorders - Other * 1  2/44 (4.55%)  3/39 (7.69%)  1/41 (2.44%) 
Peripheral motor neuropathy * 1  4/44 (9.09%)  6/39 (15.38%)  4/41 (9.76%) 
Peripheral sensory neuropathy * 1  4/44 (9.09%)  2/39 (5.13%)  5/41 (12.20%) 
Pyramidal tract syndrome * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Seizure * 1  2/44 (4.55%)  4/39 (10.26%)  0/41 (0.00%) 
Syncope * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Tremor * 1  1/44 (2.27%)  2/39 (5.13%)  2/41 (4.88%) 
Psychiatric disorders       
Agitation * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Anxiety * 1  2/44 (4.55%)  2/39 (5.13%)  2/41 (4.88%) 
Confusion * 1  4/44 (9.09%)  2/39 (5.13%)  6/41 (14.63%) 
Depression * 1  2/44 (4.55%)  1/39 (2.56%)  4/41 (9.76%) 
Insomnia * 1  3/44 (6.82%)  5/39 (12.82%)  4/41 (9.76%) 
Libido decreased * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Personality change * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Renal and urinary disorders       
Bladder spasm * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Cystitis noninfective * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Hematuria * 1  0/44 (0.00%)  0/39 (0.00%)  2/41 (4.88%) 
Hemoglobinuria * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Proteinuria * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Renal and urinary disorders - Other * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Urinary frequency * 1  1/44 (2.27%)  0/39 (0.00%)  2/41 (4.88%) 
Urinary incontinence * 1  3/44 (6.82%)  0/39 (0.00%)  1/41 (2.44%) 
Urinary tract pain * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Reproductive system and breast disorders       
Erectile dysfunction * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Vaginal hemorrhage * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Atelectasis * 1  0/44 (0.00%)  0/39 (0.00%)  2/41 (4.88%) 
Bronchospasm * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Cough * 1  6/44 (13.64%)  9/39 (23.08%)  6/41 (14.63%) 
Dyspnea * 1  9/44 (20.45%)  4/39 (10.26%)  11/41 (26.83%) 
Epistaxis * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Hiccups * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Hypoxia * 1  1/44 (2.27%)  1/39 (2.56%)  1/41 (2.44%) 
Pharyngolaryngeal pain * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Pleural effusion * 1  0/44 (0.00%)  0/39 (0.00%)  2/41 (4.88%) 
Pleuritic pain * 1  1/44 (2.27%)  0/39 (0.00%)  1/41 (2.44%) 
Pneumonitis * 1  0/44 (0.00%)  1/39 (2.56%)  3/41 (7.32%) 
Respiratory, thoracic and mediastinal disorders - Other * 1  0/44 (0.00%)  2/39 (5.13%)  0/41 (0.00%) 
Voice alteration * 1  0/44 (0.00%)  2/39 (5.13%)  1/41 (2.44%) 
Skin and subcutaneous tissue disorders       
Alopecia * 1  5/44 (11.36%)  11/39 (28.21%)  7/41 (17.07%) 
Dry skin * 1  1/44 (2.27%)  1/39 (2.56%)  2/41 (4.88%) 
Hyperhidrosis * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Nail loss * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Pain of skin * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Palmar-plantar erythrodysesthesia syndrome * 1  0/44 (0.00%)  0/39 (0.00%)  2/41 (4.88%) 
Pruritus * 1  3/44 (6.82%)  2/39 (5.13%)  3/41 (7.32%) 
Purpura * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Rash acneiform * 1  2/44 (4.55%)  1/39 (2.56%)  12/41 (29.27%) 
Rash maculo-papular * 1  0/44 (0.00%)  0/39 (0.00%)  5/41 (12.20%) 
Scalp pain * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Skin and subcutaneous tissue disorders - Other * 1  2/44 (4.55%)  1/39 (2.56%)  1/41 (2.44%) 
Skin hyperpigmentation * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Skin hypopigmentation * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
Vascular disorders       
Hypertension * 1  1/44 (2.27%)  0/39 (0.00%)  0/41 (0.00%) 
Hypotension * 1  0/44 (0.00%)  3/39 (7.69%)  1/41 (2.44%) 
Thromboembolic event * 1  2/44 (4.55%)  3/39 (7.69%)  1/41 (2.44%) 
Vascular disorders - Other * 1  0/44 (0.00%)  1/39 (2.56%)  0/41 (0.00%) 
Vasculitis * 1  0/44 (0.00%)  0/39 (0.00%)  1/41 (2.44%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
This study stopped accrual early due to unmet targeted accrual goals with 126 subjects accrued out of 381 planned.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group
EMail: wseiferheld@acr.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096265    
Other Study ID Numbers: NCI-2009-00720
NCI-2009-00720 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000389490
RTOG 0320
RTOG 0320 ( Other Identifier: Radiation Therapy Oncology Group )
RTOG-0320 ( Other Identifier: CTEP )
U10CA021661 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2004
First Posted: November 9, 2004
Results First Submitted: March 5, 2013
Results First Posted: April 16, 2013
Last Update Posted: March 9, 2018