[c09aa8]: / clusters / final9knumclusters / clust_1941.txt

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Uncontrolled tumor-related pain or impending spinal cord compression.
Patients whose primary tumors arise in the intra-dural soft tissue (eg. brain and spinal cord) are not eligible
Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are NOT eligible
Based on prior radiation records, have had most of the tumor volume (> 50%) previously radiated at doses >= 45 gray (Gy) without exceeding spinal cord tolerance (combining previous and future radiation dose to 1 cc of the spinal cord of =< 60 Gy)
Tumors involving spinal cord or heart
Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 2 weeks prior to randomization
Epidural tumor < 2 mm from spinal cord
Tumors that are primarily localized within the brainstem or spinal cord
Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
Subject has clinical signs suggestive of high or imminent risks for pathological fracture, spinal cord compression and/or cauda equina syndrome
Spinal surgery carried out with the goal of spinal cord decompression and spinal stabilization within 8 weeks
Lack of adequate (>= 2 mm) separation between the spinal cord and the tumor on post-operative CT myelogram or MRI perfusion
Extradural tumor in contact with the spinal cord or tumor located where swelling in response to therapy may impinge upon spinal cord
Evidence of spinal cord compression
Patients with tumors lying close to an airway, major blood vessel or spinal cord that, in the opinion of the investigator, could cause occlusion or compression in the case of swelling, or erosion into a major vessel in the case of necrosis.
Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment
Metastatic disease impinging on the spinal cord or threatening spinal cord compression; patients that have had previous treatment of disease with impinging on the cord with either surgery or radiotherapy with clinical or radiographic evidence of response or stability are eligible
Metastatic disease impinging on the spinal cord or threatening spinal cord compression
Subjects with known symptomatic or impending spinal cord compression, except if subject has received definitive treatment for this and demonstrates evidence of clinically stable disease
Osseous metastases felt in the opinion of the clinician to be high-risk for impending pathologic fracture or spinal cord compression
Spinal cord compression unless good pain control attained
Radiologic or clinical evidence of spinal cord compression
Patients with primary spinal cord tumors
Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g. femoral metastases with concern over fracture risk, severe and extensive spinal metastases with concern over spinal cord compression, extensive liver metastases)
Spinal cord compression not definitively treated with surgery and/or radiation
Patients with spinal disease
Patients with radiographic or clinical findings of spinal cord compression or cauda equina syndrome with neurologic deficit thought to be due to malignancy
Spinal cord compression, imminent long bone fracture, or any other condition that, in the opinion of the investigator, is likely to require radiation therapy and/or steroids for pain control during the active phase
Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 2 weeks prior to randomization
Has imminent or established cord compression based on clinical findings and/or MRI
Known spinal cord compression
Presence of extracranial metastatic, significant leptomeningeal disease or tumors primarily localized to the brainstem or spinal cord.
Spinal cord compression that has not definitively treated with surgery and/or radiation
Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
Known symptomatic or impending cord compression
Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation
Highly symptomatic patients (e.g., declining ECOG performance status; rapidly worsening symptoms; rapid progression of disease; progression of tumor at critical anatomical sites [e.g., spinal cord compression] requiring urgent alternative medical intervention) are not eligible
Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI); spinal cord compression will be defined as 360 degree circumferential obliteration of T2 cerebrospinal fluid signal around the spinal cord; treatment should be completed for spinal cord compression
Patients with evidence of tumor in the brainstem, cerebellum, optic apparatus, or spinal cord, radiological evidence of actively growing multifocal disease, or leptomeningeal disease
Patients with untreated spinal cord compression; patients with spinal cord compression may be enrolled if stable after completing surgery (may enroll 14 days after surgery) or radiation (may enroll 14 days after treatment) and must be off corticosteroids for at least 14 days prior to the start of study treatment
Planned treatment site(s) associated with spinal cord compression or canal compromise requiring decompression
Symptomatic or impending spinal cord compression or cauda equina syndrome.
Patients that require urgent therapy due to tumor mass effects or spinal cord compression
Prognostic Index for Spinal Metastases (PRISM) group 1-3
Has tumor primarily localized to the brainstem or spinal cord
Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord, radiological evidence of active (growing) multifocal disease, subependymal or leptomeningeal disease
Patients with symptomatic metastatic prostate cancer such as moderate to severe pain, impaired organ function, or spinal cord compression will be excluded from this study unless these issues have been taken care of
No history of tumors involving spinal cord or heart
Patients with symptomatic metastatic prostate cancer such as moderate to severe pain, impaired organ function or spinal cord compression will be excluded from this study unless these issues have been taken care of
Motor strength >= 4 out of 5 in extremity or extremities affected by the level of the spinal cord compression
Frank cord compression or cord compression from bone components or configuration and acute neurological deficits (defined as motor strength < 4/5 in extremity or extremities affected by the level of the spinal cord compression)
Patients with evidence of tumor in the brainstem, cerebellum, or spinal cord, or with evidence of leptomeningeal disease
PHASE II DOSE EXPANSION IN RECURRENT GBM UNDERGOING RESECTION: Has tumor localized primarily to the posterior fossa, spinal cord, or an unresectable location
PHASE I: Tumor localized primarily to the posterior fossa or spinal cord
Patients that require urgent therapy due to tumor mass effects or spinal cord compression
Has imminent or established spinal cord compression based on clinical findings and/or MRI
Tumors lying in mucosal regions or close to an airway, major blood vessel or spinal cord.
Imminent or established spinal cord compression based on clinical and/or imaging; in subjects with untreated imminent or established spinal cord compression, treatment with standard of care as clinically indicated should be completed at least 4 weeks before enrollment
Prior radiation > 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, both kidneys) within 1 year of the treatment date
Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI); treatment should be completed for spinal cord compression
Patients must have demonstrated progression of disease on MRI or computed tomography (CT) assessment of the spinal cord/cauda within the previous radiation field\r\n* Progression may consist of an increase in maximal dimension of the tumor by >= 20%, compromise of the spinal cord/cauda equina and/or exiting spinal nerves (assessed clinically or radiographically), or both
Unable to undergo either a myelogram or MRI of spinal cord/cauda equina and/or exiting spinal nerves
Patients who may not receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by the Dose Limit Guidelines \r\n* Evaluation of doses previously delivered to spinal cord/cauda equina and other critical structures (bowel, esophagus, kidneys, rectum) will be taken into consideration\r\n* If repeat irradiation would exceed any normal tissue constraint the patient will be ineligible \r\n* If the total prior radiation dose to the spinal cord/cauda equina and/or sacrum over all prior treatments exceeds 100 Gy BED (biologically effective dose), the patient will be ineligible
Tumor within 1 cm of the spinal cord
Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g. femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction)
Metastatic deposits near a great vessel or spinal cord
Subjects with spinal cord compression
Exposure to any prior chemotherapy or steroid use within 14 days of study-related drug therapy; (steroid use is allowed if necessary to treat spinal cord compression)
Prior radiotherapy to any anatomic regions that would result in overlap of radiation dose distribution to critical structures (esophagus, heart, spinal cord, brachial plexus)
T4 tumor with direct invasion of esophagus, spinal cord, major blood vessel, or heart
Patients with primarily infra-tentorial or spinal cord tumor are not eligible
Patient with epidural, spinal nerve, and/or cord compression on MRI may be included
Subjects with radiographic signs of excessive intracranial mass effect with associated rapid neurologic deterioration, and/or spinal cord block
Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated but without evidence that disease has been clinically stable for >/=2 weeks prior to Day 1 of Cycle 1
Evidence of spinal cord compression or CNS complication unless controlled by appropriate therapy.
Clinical spinal cord compression syndromes (unless patient has undergone treatment, for example, surgery or radiation therapy, and neurological findings are ? Grade 1 and patient is off corticosteroids for spinal cord edema or on a stable regimen of < 10 mg/day prednisone equivalent
Patients with primary tumor location of brainstem or spinal cord
Evidence of disease that, in the opinion of the investigator, would put the patient at risk from testosterone therapy (e.g. femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction)
Spinal cord compression or impending spinal cord compression
Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI); treatment should be completed for spinal cord compression
Patients with symptomatic metastatic prostate cancer experiencing moderate to severe pain, impaired organ function or spinal cord compression will be excluded from this study unless these issues have been addressed
Subjects with radiographic signs of excessive intracranial mass effect with associated rapid neurologic deterioration and/or spinal cord block
Tumors primarily localized in the infratentorial compartment or spinal cord – tumors with limited infratentorial compartment or spinal cord involvement are eligible
Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
Patients that require urgent therapy due to tumor mass effects or spinal cord compression
Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
The entire tumor volume must be included in a treatment field that limits the total spinal cord dose to 54 Gy (prior plus planned dose)
Current symptomatic cord compression requiring surgery or radiation therapy
Patients must have symptomatic multiple myeloma without advanced organ damage (such as multiple fractures or advanced bone disease causing immobilization, renal failure, spinal cord compression, or organ compromise due to soft tissue plasmacytoma); if immediate therapy with radiation and high-dose steroids (e.g., for spinal cord compression) or if triple therapy is clearly advisable from the start, the patient is not eligible for this trial
Complicated bone metastases including clinical or radiological evidence of spinal cord compression or impending pathological fracture
Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for greater than (>) 2 weeks prior to randomization
First day of dosing with tesevatinib is less than 4 weeks from the last radiotherapy of the brain or spinal cord/cauda equina
No history of tumors involving spinal cord or heart
No tumors involving spinal cord or heart
Subjects must have experienced no more than two skeletal-related events (SREs) prior to study entry defined as: Need for external beam radiotherapy (EBRT) tor bone, pathological bone fracture (excluding major trauma), spinal cord compression and/or orthopedic surgical procedure. Subjects with no prior SREs are not permitted.
Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
Anticipated treatment of the index tumor that would require iceball formation within 0.5 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel (possibly achieved with additional maneuvers such as hydrodissection)
Patients may have received prior radiotherapy for symptomatic localized bone lesions or impending spinal cord compression only; radiotherapy must be completed at least 14 days prior to registration and all toxicities must have resolved to =< grade 1
Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 2 weeks prior to screening
Spinal cord compression not definitively treated or not clinically stable
Subject has experienced acute pathologic fracture or spinal cord compression within 28 days prior to first dose of study therapy
Presence of tumor cells in the brain or spinal cord that have not been treated
Evidence of diffuse subependymal disease or tumor in the brainstem, cerebellum, spinal cord, or CSF.
Spinal cord compression or impending spinal cord compression
Imminent or established spinal cord compression based on clinical and/or imaging; in patients with untreated imminent or established spinal cord compression, treatment with standard of care as clinically indicated should be completed at least 4 weeks before enrollment
Patients with evidence of tumor in the brainstem, cerebellum, or spinal cord, radiological evidence of multifocal disease, or leptomeningeal disease
Following breast cancer disease conditions are not eligible:\r\n* Single bone lesion\r\n* Two or more visceral metastasis\r\n* Single visceral lesion < 2 cm without any laboratory changes or clinical symptoms due to the metastatic lesion is permitted\r\n* Presence of brain metastases\r\n* Imminent spinal cord compression based on clinical findings and/or MRI\r\n* Impending fracture, spinal cord compression, and/or potentially unstable compression fracture of vertebral body with possibility of cord compression\r\n* Life expectancy severely limited by concomitant illness (less than 12 months)\r\n* Concurrent external beam radiation therapy to non-target lesion is permitted
Has tumor localized primarily to the brainstem or spinal cord
Has tumor primarily localized to the brainstem or spinal cord
Current or imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI); treatment should be completed for spinal cord compression
The generated planning target volume 1 (PTV1) must be > 5 mm from the spinal cord or brain
The generated PTV1 is located within 5 mm of spinal cord or brain
Have current spinal cord compression.
Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Subjects with history of spinal cord compression should have completely recovered
Have active cancer in the brain or spinal cord
Subject has clinical signs suggestive of high or imminent risks for pathological fracture, spinal cord compression and/or cauda equina syndrome.
Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
Histologically confirmed, previously untreated CD30+ classical HL; (participants receiving limited emergent radiation therapy [RT] or steroid therapy - maximum of 7 days - because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment)
Tumor to be treated should not directly about the spinal cord, and should have at least 5mm separation from the spinal cord; for patients with tumors closer than 5mm, inclusion is permissible at the discretion of the treating radiation oncologist such that dosimetric review demonstrates that the total dose to spinal cord is within tolerable range of < 10 Gy to 10% partial volume or max point dose 18 Gy
Patients with evidence of spinal instability OR neurologic deficit resulting from bony compression of neurologic structures
Any patient with symptoms of pain, compression fracture, neurologic deficit attributable to spinal metastases will not be included
Patients with neoplastic lesions in the brainstem, cerebellum or spinal cord, radiological evidence of active (growing) multifocal disease, or leptomeningeal disease will be excluded; patients with evidence of diffuse subependymal disease or tumor in the brainstem, cerebellum, spinal cord, or cerebrospinal fluid (CSF) will also be excluded\r\n* Patients with radiological evidence of active (growing) multifocal disease, tumors extending into or crossing the corpus callosum or leptomeningeal disease, will be excluded
Must be no clinical or radiographic evidence of spinal cord compression
Prior spinal cord maximum dose at level of vertebral disease must be =< 50 Gy
Patients must have symptomatic multiple myeloma without advanced organ damage (such as multiple fractures or advanced bone disease causing immobilization, renal failure, spinal cord compression, or organ compromise due to soft tissue plasmacytoma); if immediate therapy with radiation and high-dose steroids (e.g., for cord compression) or with bortezomib-based therapy (e.g., for renal failure) is required, the patient is not eligible for this trial
Spinal cord compression within 6 months
Spinal cord compression or canal compromise requiring decompression,
Index tumor(s) causing clinical or radiographic evidence of spinal cord or cauda equine compression/effacement
Patients with evidence of other tumor masses in the spinal cord will be eligible unless there is evidence of spinal cord block radiographically or clinically
Anatomical considerations:\r\n* If the patient has >= 4 sites; only the 3 most painful sites of disease will be treated; or, in the absence of pain, the 3 levels at greatest risk of impending collapse, based on extent of involvement, presence of posterior element involvement, or biomechanical risk based on location (mid-thoracic area, thoraco-lumbar junction, lumbosacral junction)\r\n* Spinal cord compression with or without peridural spread\r\n* Neurologic compromise due to spinal cord compression
PART II: Participants must be without evidence of active spinal cord compression
Prior treatment for MM (prior radiation therapy or dexamethasone up to 160 mg for spinal cord compression is allowed. Other limited field radiation involving ? 1/3 of the pelvic area is also allowed)
Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis.
Participant has spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to screening Treatment-Specific Exclusion Criteria:
Conditions related to tumor, which require emergency treatment (airway compression, spinal cord compression) since enrollment would delay initiation of such therapy
Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI); treatment should be completed for spinal cord compression
Symptomatic or impending spinal cord compression or cauda equine syndrome
Symptomatic or impending spinal cord compression or cauda equina syndrome.
Spinal cord or cauda equine compression/effacement in vertebral metastases with neurological symptoms other than just pain for the lesion that is planned for treatment
Patents with cord compression
Patients with epidural compression are eligible provided that there is a >= 3 mm gap between the spinal cord and the edge of the epidural lesion
Frank spinal cord compression or displacement or epidural compression within 3 mm of the spinal cord
Presence of spinal cord injury including any form of paraplegia or quadriplegia
History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity
Peripheral neuropathy caused by tumor infiltration or compression of spinal nerves or surgical trauma
History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity
Congenital spinal defect/paraplegia
Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
Subjects must have experienced no more than two skeletal-related events (SREs) prior to study entry defined as: need for external beam radiotherapy (EBRT) to bone pain, pathological bone fracture (excluding major trauma), spinal cord compression and/or orthopedic surgical procedure. Subjects with no prior SREs are not permitted.
Any spinal pathology which can prevent safe administration of epidural/ spinal anesthesia
Eminent or established cord compression as assessed by medical record review
Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomization
Spinal cord compression.
Primary brainstem or spinal cord tumor
Spinal cord compression is excluded unless the patient demonstrates good pain control attained through therapy and there is stabilization or recovery of neurological function for two weeks prior to study entry
History of spinal cord compression
Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 2 weeks prior to enrollment
Spinal cord compression.