[c09aa8]: / clusters / final9knumclusters / clust_667.txt

Download this file

77 lines (76 with data), 12.6 kB

 1
 2
 3
 4
 5
 6
 7
 8
 9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
There is at least 1 metastatic site at one or more of the following sites: spine or non-spine bone and at maximum 5 sites can be treated on protocol
A MRI of the spine is required within 10 days prior to or at least 10 days after surgery
Pathologically proven metastatic solid tumor (non-hematologic malignancy) of the bone (spine or non-spine bone)
Primary spine tumor
Women with severe bone density issues/osteoporosis (defined as any medical treatment for osteoporosis, and/or a T-score of -2.5 or lower, and/or history of fracture of the hip or spine)
Pts w/ osteopenia (T-score of -1 to -2.5 at L/R total hip, L/R femoral neck or lumbar spine [L1-L4]) eligible
Radiation to spine/pelvis bone or chemoradiation to pelvic organs
Osteoporosis (T-score of <?2.5 at L/R total hip, L/R femoral neck, or lumbar spine [L1-L4] by DEXA scan)
INCLUSION CRITERIA FOR STRATUM C: All subjects must have measurable disease in 2-dimensions on MRI scan of the brain and/or spine; disease should be consistently measured with the two largest perpendicular dimensions
Primary brain or spine tumor are eligible, including tumors with metastases, multiple lesions
Fractures due to prostatic cancer or other osteoblastic metastases to the spine
Had prior lumbar spine surgical procedures that could impair the ability to perform the injection.
All patients must have histologic proof of solid tumor malignancy and radiographic evidence of spine metastasis
MR imaging of the total spine (performed within 14 days of enrollment) demonstrates no evidence of spinal metastatic disease
Patients must have histologically confirmed diagnosis of melanoma; the pathologic confirmation may be from another metastatic site or from metastatic brain or spine lesions
Patients must have stage IV melanoma, with newly identified brain or spine metastases
Prior whole brain radiation or conventional radiation to the spine at the site of new lesion
Patients with both brain and spine metastases will be excluded from the trial
No more than 3 contiguous or discontiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session or 3 sessions
Prior conventional irradiation of the spine site and level to be treated with an interval shorter than 3 months
Prior surgery to the same levels of spine
MRI (contrast is not required but strongly recommended) or CT myelogram of the involved spine within 1 week prior to registration to determine the extent of the spine involvement
Cord compression at 2 non-contiguous sites in the spine
Spine instability as determined by Spinal Instability Neoplastic Score (SINS) score > 12
Prior radiation to the index spine
All patients must have a brain MRI with and without contrast (gadolinium) within 30 days prior to study enrollment; all patients with history of spinal or leptomeningeal disease and those patients with symptoms suspicious of spinal disease, must have a spine MRI with contrast (gadolinium) performed within 30 days prior to study enrollment; lumbar puncture is necessary if there is evidence of tumor dissemination on the MRI of spine
Patients must have radiographic evidence of malignancy in the spine or cauda equina region (L2 to sacrum) which is suitable for radiation therapy
Patients must not have received radiation therapy to more than 20% of hematopoiesis forming bones (spine, pelvis and proximal long bones) during lifetime
Tumors arising in the skull and spine
No evidence of metastatic disease in the brain, spine or cerebrospinal fluid (CSF); assessments must include magnetic resonance imaging (MRI) imaging of the brain and spine with and without contrast and a lumbar puncture for CSF cytology
A MRI of the spine is required within 10 days prior to or at least 10 days after surgery
Patients with instability of the spine requiring instrumentation as judged by a neurosurgeon are not eligible
For stratum B, patients must have disseminated recurrent disease (defined as multifocal disease, positive spine MRI including leptomeningeal disease and/or positive cytology within 21 days prior to study registration) and have adequate cerebrospinal fluid (CSF) flow based on spine MRI with no evidence of bulky disease or if bulky disease is present based on a CSF flow study per institutional guidelines; children must have undergone what is considered the standard of care as upfront therapy including either surgery followed by high dose chemotherapy with stem cell rescue or multi-modality therapy of surgery, radiation and chemotherapy
All patients must have a cranial MRI with and without gadolinium at diagnosis/prior to enrollment; if surgical resection is performed, patients must have pre-operative and post-operative cranial MRI with and without gadolinium; the post-operative brain MRI should be obtained within 72 hours of surgery; if patient has a biopsy only, post-operative cranial MRI is recommended but not required; all patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment; Note: if the spine study is performed for the first time after surgical resection or biopsy, it is recommended to be obtained with and without gadolinium
Patients whose tumors arise in the dural and intra-dural soft tissues of the cranium and spine are not eligible
Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar CSF cytology are not eligible
All patients must have a brain MRI with and without gadolinium and a spine MRI with gadolinium performed within 2 weeks prior to study enrollment
Patients with disseminated disease to the spine are not eligible, and MRI of spine must be performed prior to enrollment if the treating physician suspects disseminated disease.
Prior radiation or radiosurgery to the involved level of the spine
Spine disease from leukemia, lymphoma or myeloma
Patient with >= 1 asymptomatic spinal metastases of the thoracic spine OR >= 1 asymptomatic spinal metastases of the lumbar spine may be included; patients with spinal metastases to multiple vertebral levels may be included at the discretion of the investigator; however, only one vertebral level will be treated
Patients with lesions in the upper cervical spine (C1-C5) or cervicothoracic junction (C6-T3)
Prior irradiation of the spine site and level to be treated
Pathological diagnosis of chondrosarcoma of the spine or sacrum or chordoma of the spine, or sacrum
SPINE AND PARASPINAL LESIONS:
Patients with disseminated intrinsic diffuse brainstem gliomas in either brain or spine; spine MRI should be performed prior to biopsy if clinically indicated
Index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty,
Major surgery of the spine in same region as the index vertebra(e) was performed within 3 months before enrollment,
Major elective surgery to the spine in same region as the index vertebra(e) is planned within 1 month following the ablation and cement procedure,
If the index tumor is in the spine, there must be an intact cortex between the mass and the spinal canal and exiting nerve roots
Osteoporosis based on a T-score of <-2.5 at the left or right total hip, left or right femoral neck or lumbar spine (L1-L4) as determined by DEXA scan
Osteoporosis based on a T-score of <-2.5 at the left or right total hip, left or right femoral neck or lumbar spine (L1-L4) as determined by DEXA scan
Osteolysis of a vertebral body(ies) with or without fracture at a site of metastatic infiltration/multiple myeloma, that poses risk of impending vertebral collapse; this is detected by the following cross-sectional imaging (MRI or CT) conditions:\r\n* In the thoracic spine: \r\n** A >= 50% involvement of the vertebral body with no destruction of other structures or;\r\n** A >= 25% involvement of the vertebral body associated with costovertebral joint destruction or posterior elements involvement\r\n* In the lumbar spine: \r\n** A >= 35% involvement of the vertebral body with no destruction of other structures or;\r\n** A >= 20% involvement of the vertebral body associated with involvement of posterior elements
In the investigator's judgment, focal neurologic deficit as a result of metastases in the brain, spine, or other central nervous system disorders.
Osteoporosis based on a T-score of <-2.5 at the left or right total hip, left or right femoral neck or lumbar spine (L1-L4) as determined by DEXA scan
Osteoporosis based on a T-score of <-2.5 at the left or right total hip, left or right femoral neck or lumbar spine (L1-L4) as determined by DEXA scan
Minimal volume, non-disseminated disease, defined by the following: \r\n* Residual tumor ? 1.5 cm^2 confirmed by MRI with contrast imaging within 21 days after surgery\r\n* No metastatic disease in the head, spine, or cerebrospinal fluid (CSF) confirmed by both of the following: \r\n** Enhanced MRI of the spine within 5 days before surgery OR within 28 days after surgery\r\n** Negative cytological examination of CSF after surgery, but before study enrollment
History of a primary bone malignancy involving the lumbar spine
Clinically significant fractures as defined by International Society for Clinical Densitometry (ISCD) (a long bone fracture of the lower extremities, vertebral compression fracture, or two or more long bone fractures of the upper extremities) indicated by a cast or a spine x-ray within the last 2 weeks
History of prior trauma or orthopedic surgery to the cervical vertebral column/spine
All patients must have histologic proof of solid tumor malignancy and radiographic evidence of spine metastasis
All patients must have a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gray (Gy)
All patients must be deemed at \high risk\ of developing vertebral body fracture by having at least one of the following characteristics: \r\n* Spine Instability Neoplastic Score classification of \Indeterminate\ deemed as a score from 7 to 12\r\n* Pre-existing vertebral body fracture\r\n* Planned radiation dose of 24 Gy
Patients who have had prior radiotherapy at the spine site and level to be treated
Patients who have had prior surgery at the spine level to be treated to include prior cement augmentation, laminectomy, vertebrectomy, tumor debulking, instrumentation
The patient must have localized spine metastasis from the cervical (C)1 to lumbar (L)5 levels by a screening imaging study (bone scan, positron emission tomography [PET], computed tomography [CT], or MRI) (a solitary spine metastasis; two separate spine levels; or up to 3 separate sites [e.g., C5, thoracic (T)5-6, and T12] are permitted;) each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies; patients can have other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible
Eligible metastatic lesions: 1) a solitary spine metastasis; 2) two contiguous spine levels involved; or 3) a maximum of 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies; epidural compression (arrow) is eligible when there is a >= 3 mm gap between the spinal cord and the edge of the epidural lesion; a paraspinal mass =< 5 cm is allowed
There can be multiple small metastatic lesions shown in other vertebral bodies; the metastatic lesion of each spine should be less than 20% of the vertebral body as opposed to the diffuse vertebral involvement; these small lesions are often seen in the MRI even when bone scan or PET was negative; most of these lesions are not clinically required to be treated and are therefore not included in the target volume of this protocol; only the painful spine (pain score >= 5) is to be treated
Patients with a paraspinal mass =< 5 cm in the greatest dimension and that is contiguous with spine metastasis are eligible
Spine instability due to a compression fracture
Prior radiation to the index spine
Patients for whom an MRI of the spine is medically contraindicated
History of severe osteoporosis (T score =< -4 either spine or hip), or presence of vertebral fracture
Women with known osteoporosis or history of osteoporotic (fragility) fracture of the spine
Osteoporosis: patients with a history of fragility fracture, or a hip or spine T score of < -2.5 (these patients will be treated with zoledronic acid and followed, but excluded from randomization)
Tumors near critical structures such as those located near or in the brain or spine. This assessment will be determined by the treating clinician.