[c09aa8]: / clusters / ordered9kclusters / clust_165.txt

Download this file

37 lines (36 with data), 8.1 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
Patients must have stage cT2-T4a N0 M0 disease; clinical T stage is based on the transurethral resection of the bladder tumor (TURBT) sample, exam under anesthesia and cross-sectional imaging studies; patients must undergo cystoscopy and TURBT as part of the staging procedure within 120 days prior to registration; to exclude non-bulky/low-risk tumors, subjects must have documented muscle invasion with at least one of the following:\r\n* Disease measuring at least 10 mm on cross-sectional imaging; bladder thickening on imaging, by itself, is not adequate\r\n* The presence of tumor-associated hydronephrosis
Patients with tumor morphology that predicts poor coverage of the majority of the tumor including bilateral thalamic involvement, or cysts that represent > 50% of cross-sectional areas of the pons. These subjects should be discussed with the study chairs.
Three or fewer total sites of active disease (at least one site of active disease to be treated on study must be confined to the abdomen or pelvis excluding liver and must be < 5 cm in greatest dimension as determined by pre-screening cross-sectional imaging)
No evidence of clinical progression, in the form of increased lesions on cross-sectional imaging, or new cancer-attributable symptoms or worsening of existing symptoms
Subjects must have metastatic disease detectable by either bone scan or cross sectional imaging by CT or magnetic resonance imaging (MRI) as per the PCWG3 guidelines
Cross-sectional imaging evidence of progression of recurrent/metastatic disease
Patients must have progressive metastatic disease defined as new or progressive lesions on cross-sectional imaging
Dose-volume histogram data and cross-sectional imaging from previous radiation must be obtained; electronic dosimetry records in Digital Imaging and Communications in Medicine (DICOM) format from previous radiation are strongly preferred
< 90% solid component of tumor on screening cross-sectional imaging
MAIN STUDY COHORT INCLUSION CRITERIA: Presence of a solid enhancing cT1 renal mass (i.e. =< 7 cm) diagnosed on cross-sectional imaging
Documented recurrent disease: recurrent disease is defined either as radiological confirmation of the tumor, as an increase in tumor size of at least 25% based upon serial magnetic resonance (MR) images, or as development of a new site of disease\r\n* Tumor volume will be calculated using the sum of the largest cross-sectional perpendicular diameters of contrast-enhancing tumor, the sum of the largest cross-sectional perpendicular diameters of fluid attenuated inversion recovery (FLAIR) abnormality, or as worsened spectroscopic characteristics for any tumor type (development of >= 2 new voxels with choline to N-acetyl aspartate index [CNI] >= 3, or >= 25% increase in the sum of the CNI ratios within a group of previously abnormal voxels [where abnormal is defined as CNI ? 3])\r\n* Disease must be evaluable, but does not need to be measurable\r\n* The target site for SRS does not need to be located in a previously-irradiated area
Resectable disease at the time of enrollment based on high-quality, preoperative, cross-sectional imaging of the chest, abdomen, and pelvis (C/A/P)
Unresectable gallbladder cancer at the time of enrollment based on high-quality, preoperative, cross-sectional imaging of the C/A/P
Presence of visceral metastases (e.g. lung, liver) detectable on cross-sectional imaging or bone metastases requiring the use of opioid analgesic or focal radiation treatment at the time of study entry
Diagnostic quality, cross sectional imaging of the thorax within 28 days prior to registration; 18-F-FDG-PET/CT or conventional CT are acceptable.
Patients with locally advanced bladder cancer based on cross-sectional imaging (suspicion of extravesical disease or hydronephrosis)
Patients must have stage cT2-T4a N0 M0 disease; clinical T stage is based on the transurethral resection of bladder tumor (TURBT) sample and imaging studies; patients must undergo cystoscopy and TURBT as part of the staging procedure within 56 days prior to registration; to exclude non-bulky/low-risk tumors and ensure adequate tissue for assessment, subjects must have documented muscle invasion with at least one of the following:\r\n* Disease measuring at least 5 mm on cross-sectional imaging or by endoscopic assessment; bladder thickening on imaging without definable tumor is not adequate; pathology verification of >= 0.5 cm of viable tumor (longest diameter) from the biopsy sample and represented on the submitted slides is also acceptable\r\n* The presence of tumor-associated hydronephrosis
Histologically confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging
Evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.
Either FDG-avid on FDG-PET or measurable disease by CT on cross sectional imaging: > 1.5 cm for nodal lesion, > 1.0 cm for extra nodal lesion.
Evidence of metastatic disease on cross sectional imaging or bone scan
MRI/CT must demonstrate measurable enhancing tumor of at least 1 cm^2 in cross-sectional area to allow assessment of radiographic response
Targeted index tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm, measured in the longest cross sectional dimension.
Measurable disease on cross sectional imaging of at least 1 cm
Patients in the phase I portion must have:\r\n* Histologically confirmed diagnosis of metastatic, genitourinary solid tumor\r\n* Metastatic disease defined as new or progressive lesions on cross-sectional imaging; patients must have at least:\r\n** One evaluable site of disease \r\n** Or, appearance of one new bone lesion
Randomization within 112 days of completion of surgical \r\n* The primary region must be included on cross-sectional imaging (e.g. sinus/neck if arising from sinonasal primary; pelvis if genitourinary); radiographic changes considered nonspecific or possibly due to surgery or radiation are not considered evidence of disease
< 90% solid component on screening cross-sectional imaging
Clinical eligibility supported by central imaging real-time review\r\n* The presence of at least the following conventional magnetic resonance (MR) image characteristic:\r\n** Conventional MR\r\n*** Lesion quotient of < 0.3, where lesion quotient is defined as the proportional value of the maximum axial cross-sectional area of the transverse relaxation time (T2)-weighted defined lesion over the maximum axial cross-sectional area of the contrast-enhancing lesion on the longitudinal relaxation time (T1)-weighted post-gadolinium sequence on a comparable axial slice
Evidence of low-volume peritoneal disease defined by a peritoneal carcinomatosis index (PCI) =< 10 based on cross-sectional imaging and/or diagnostic laparoscopy findings
Cohort A only: Presence of at least three distinct metastatic lesions by standard imaging including whole body bone scan + cross-sectional imaging of the abdomen and pelvis obtained within 12 weeks prior to protocol scan
CT or MRI must demonstrate at least one lesion (primary or metastatic) present 1.5 cm or larger in any dimension on cross-sectional imaging (CT or MRI) obtained within 3 months of study enrollment
Completed radiographic evaluation with whole-body bone scan (99mTc-MDP or Na18F) and cross-sectional imaging (CT or magnetic resonance imaging [MRI]) of the abdomen and pelvis =< 42 days prior to study enrollment
No evidence of metastatic disease on conventional imaging, including a negative bone scan for skeletal metastasis and/or negative cross section imaging (MR or CT)
At least 1 measurable site of disease on cross-sectional imaging (CT/PET)
Subjects must have at least 1 lesion being targeted by TACE that is > 2 cm in the longest cross-sectional (axial plane) diameter
Cohort B only:- Presence of at least three distinct metastatic lesions by standard imaging including whole body bone scan + cross-sectional imaging of the abdomen and pelvis obtained within 12 weeks prior to protocol scan