Downloads: 1
| # | Blank 1 | Frequency | Blank 2 | Frequency | |
|---|---|---|---|---|---|
| 1 | 14 | known | 29 | 105 | |
| 2 | 18 | patients with known | 21 | . | 14 |
| 3 | 1 | 15 | or leptomeningeal metastases | 9 | |
| 4 | 7 | active | 14 | are eligible provided r n the brain metastases have been treated r n the patient is asymptomatic from the brain metastases r n corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days prior to registration r n the brain metastases are stable on pre registration imaging | 2 |
| 5 | 36 | patients with | 8 | in the genu | 2 |
| 6 | 4 | uncontrolled | 5 | or a history of brain metastases | 2 |
| 7 | 6 | subjects with | 5 | patients with brain metastases must be asymptomatic and off corticosteroids for at least one week | 2 |
| 8 | 59 | presence of | 5 | considered unstable as | 2 |
| 9 | 61 | symptomatic | 4 | and / or carcinomatous meningitis | 2 |
| 10 | 69 | subjects with known | 4 | . patients with treated brain metastases who are off corticosteroids for at least two weeks and who demonstrate control of brain metastases with follow up imaging 4 or more weeks after initial therapy are eligible . | 1 |
| 11 | 3 | patients with untreated | 3 | or who have a history of brain metastases . | 1 |
| 12 | 11 | patients with uncontrolled | 3 | brain imaging is not required | 1 |
| 13 | 26 | history of | 3 | that | 1 |
| 14 | 32 | patients with a prior history of | 3 | at time of initial brain metastases diagnosis surgery to one of the brain lesions and / or biopsy of a lesion for diagnostic purposes and / or for standard of care purposes is acceptable | 1 |
| 15 | 33 | subjects with active | 3 | are eligible | 1 |
| 16 | 106 | subject has known | 3 | who are clinically unstable | 1 |
| 17 | 155 | active or progressing | 3 | that are non progressing . | 1 |
| 18 | 17 | recurrent | 2 | symptomatic brain metastases brain metastases requiring steroids to manage symptoms or treatment for brain metastases within 8 weeks prior to randomization | 1 |
| 19 | 25 | presence or history of | 2 | must be stable for at least 3 months after treatment a brain computed tomography ct scan or mri is only be required in subjects with known brain metastases at the time of enrollment or in subjects with clinical signs or symptoms suggestive of brain metastases | 1 |
| 20 | 37 | if history of | 2 | a scan to confirm the absence of brain metastases is not required for asymptomatic patients | 1 |
| 21 | 41 | patient with a known history or evidence of | 2 | excluding previously treated and stable brain metastases | 1 |
| 22 | 43 | patients with active | 2 | meeting either of the following exclusion criteria r n untreated brain metastases r n after completion of brain directed therapy the patient has not been able to tolerate discontinuation of steroids or a decrease in steroid dose | 1 |
| 23 | 48 | history or evidence of | 2 | asymptomatic brain metastases are permitted provided that there is no steroid requirement no more than 4 metastases detected on standard mri imaging no metastatic brain lesion that is > = 3 cm in size and no lepto meningeal disease | 1 |
| 24 | 98 | have known | 2 | total | 1 |
| 25 | 105 | documented | 2 | if previously present the metastases must have been treated at least two months before participation in this study ct or mri scan of the brain is mandatory to assess the presence or not of brain metastases | 1 |
| 26 | 109 | has known | 2 | seizures or underlying brain injury | 1 |
| 27 | 2 | no active | 1 | patients with known brain metastases are eligible if the metastases are asymptomatic and previously treated | 1 |
| 28 | 5 | females who are pregnant or breastfeeding . patients who have active or stable | 1 | are ineligible subjects with treated brain metastases are eligible if they have no radiographic or other signs of progression in the brain for > = 4 weeks after completion of local therapy | 1 |
| 29 | 8 | some types of | 1 | or who have signs / symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rmcLe out the presence of brain metastases patients with brain metastases that have been definitively treated and on stable or decreasing dose of steroid within 4 weeks of starting study treatment will be eligible | 1 |
| 30 | 9 | patients may not have diagnosed | 1 | patients with known brain metastases are allowed if they are asymptomatic | 1 |
| 31 | 19 | patients with 1 10 untreated | 1 | within the last four years | 1 |
| 32 | 22 | the presence of known | 1 | except as allowed in section 4 . 1 . 14 of the protocol . neurological assessment will be used to determine brain metastases . | 1 |
| 33 | 23 | patient has known | 1 | are not eligible . patients with treated brain metastases are eligible if | 1 |
| 34 | 27 | history of prior | 1 | or irradiated stable brain metastases | 1 |
| 35 | 28 | the patient has active | 1 | if a patient has brain metastases and is on steroids the steroid dose must have been stable for at least 14 days or brain metastases that have not been previously treated | 1 |
| 36 | 29 | history of or current | 1 | even if treated | 1 |
| 37 | 31 | patients must have a history of | 1 | shomcLd be excluded from this clinical trial no additional workup is needed to exclude brain metastases if the patient is asymptomatic or has no history of brain metastases | 1 |
| 38 | 34 | untreated | 1 | except brain metastases that have been previously removed or irradiated and currently have no clinical impact | 1 |
| 39 | 35 | patient does not have any | 1 | must be stable for at least 3 months after treatment a brain computed tomography ct scan will only be required in subjects with known brain metastases at the time of enrollment or in subjects with clinical signs or symptoms suggestive of brain metastases | 1 |
| 40 | 46 | greater than 10 | 1 | patients with treated and stable for at least 4 weeks brain metastases are eligible brain metastases will not be considered measurable lesions for the purpose of this trial | 1 |
| 41 | 50 | patient must have 10 or less | 1 | including treated or stable brain metastases | 1 |
| 42 | 52 | the patient has symptomatic | 1 | from a systemic solid tumor | 1 |
| 43 | 54 | more than four additional diagnosed | 1 | certain exceptions allowed | 1 |
| 44 | 56 | patients must have 1 5 | 1 | except those meeting the following criteria a . brain metastases have been treated locally have not been progressing at least 2 months after completion of therapy and no steroid maintenance therapy is required | 1 |
| 45 | 57 | current symptomatic | 1 | are allowed provided that the patient is clinically asymptomatic and stable patients with a prior history of symptomatic brain metastases are eligible provided r n the brain metastases have been treated r n the patient is asymptomatic from the brain metastases at enrollment r n corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days prior to registration r n the brain metastases are stable on pre registration imaging | 1 |
| 46 | 58 | gliomas are excluded as well as any history of | 1 | that meet certain conditions | 1 |
| 47 | 62 | must not have known | 1 | because the study drug has not been adequately tested in this setting | 1 |
| 48 | 63 | patients with symptomatic or progressive | 1 | known brain metastases are allowed if asymptomatic and previously treated | 1 |
| 49 | 71 | patient with active | 1 | or unevaluated neurologic symptoms suggestive of brain metastases subjects with brain metastasis and documented stable disease for > = 6 weeks may be included in this study brain metastases will not be considered measurable lesions for the purposes of this trial | 1 |
| 50 | 73 | either no | 1 | are not eligible for participation | 1 |
| 51 | 85 | patients must not have active | 1 | and / or unresectable sarcoma | 1 |
| 52 | 90 | nsclc subjects with known | 1 | and infections patients with brain metastases treated with gamma knife gk or whole brain radiation within 24 hours of registration | 1 |
| 53 | 91 | gastric adenocarcinoma subjects with | 1 | are excluded if their brain metastases are | 1 |
| 54 | 92 | all subjects with | 1 | appropriate imaging shomcLd be done to rmcLe out brain metastases | 1 |
| 55 | 99 | patients must not have history of | 1 | . when brain metastases are present they do not need to have progressed after radiation therapy | 1 |
| 56 | 100 | no known | 1 | shomcLd have their brain metastases treated prior to enrollment on this protocol subjects may enroll on this trial after completion of whole brain radiation therapy and / or stereotactic radiosurgery provided they are clinically without evidence of progressive brain metastases | 1 |
| 57 | 108 | patients must not have known | 1 | primary brain tumors or brain as the only site of disease | 1 |
| 58 | 110 | there is no limit on the number of | 1 | are eligible provided r n the brain metastases have been treated r n the patient is asymptomatic from the brain metastases r n corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days prior to registration | 1 |
| 59 | 115 | patient has a known history or evidence of | 1 | from breast cancer | 1 |
| 60 | 116 | one or more | 1 | systematic screening of patients not mandatory | 1 |
| 61 | 124 | documented and ongoing | 1 | are excluded however patients with stable brain disease off corticosteroids at least 2 weeks after completion of appropriate therapy for their brain metastases are eligible | 1 |
| 62 | 128 | no more than 4 | 1 | patients with previously treated brain metastases are eligible patients with known brain active metastases must be excluded from this clinical trial | 1 |
| 63 | 132 | active seizure disorder or evidence of | 1 | . subjects with known brain metastases are eligible if | 1 |
| 64 | 134 | known or suspected | 1 | scan required at screening | 1 |
| 65 | 135 | patients with hemorrhagic | 1 | are excluded | 1 |
| 66 | 137 | previously documented or current | 1 | patients with brain metastases are permitted if they have received appropriate therapy and demonstrated control of the brain metastases following therapy patients with known brain metastases will require magnetic resonance imaging mri brain to demonstrate disease control prior to enrollment lack of symptom progression for two weeks off therapeutic doses of steroids excluding chronic steroids used for control of chronic obstructive pmcLmonary disease copd | 1 |
| 67 | 144 | subjects with leptomeningeal metastases may or may not have | 1 | history of brain metastases or radiation to the brain . | 1 |
| 68 | 145 | clinically active | 1 | have been treated . | 1 |
| 69 | 147 | subjects with known or suspected | 1 | either remote or current or presence of carcinomatous meningitis are not eligible | 1 |
| 70 | 148 | history or clinical evidence of | 1 | or carcinomatous meningitis | 1 |
| 71 | 160 | patients with known uncontrolled | 1 | or leptomeningeal metastases are not allowed . | 1 |
| 72 | 162 | patient must not have known active | 1 | leptomeningeal disease or bone metastases | 1 |
| 73 | 166 | known history or evidence of | 1 | or leptomeningeal metastases are not allowed | 1 |
| 74 | 168 | first presentation of | 1 | except as for inclusion criterion 6 . | 1 |
| 75 | 169 | subjects may have distant metastasis including | 1 | unless asymptomatic and treated or leptomeningeal metastases including suspected leptomeningeal spread with positive cytology | 1 |
| 76 | 176 | participant had breast cancer with | 1 | or leptomeningeal metastases . | 1 |
| 77 | 180 | known history of | 1 | NA | |
| 78 | 181 | evidence for hemorrhage within any of the | 1 | NA | |
| 79 | 183 | subject has known history of | 1 | NA | |
| 80 | 190 | known active | 1 | NA | |
| 81 | 192 | clinical evidence of | 1 | NA | |
| 82 | 194 | participants must not have active | 1 | NA | |
| 83 | 202 | leptomeningeal metastases or | 1 | NA | |
| 84 | 207 | has active | 1 | NA |