ID

29370

Description

Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies; ODM derived from: https://clinicaltrials.gov/show/NCT01079832

Link

https://clinicaltrials.gov/show/NCT01079832

Keywords

Versions (1)
  1. 3/21/18 3/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Fallopian Tube Cancer NCT01079832

English

Eligibility Fallopian Tube Cancer NCT01079832

1 forms  
Criteria
Description

Criteria

pathologically proven gynecologic malignancy
Description

Malignant Gynecologic Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0699889
no prior cryosurgery or radiofrequency ablation, in target lesion
Description

Target Lesion Cryosurgery Absent | Target Lesion Radiofrequency ablation Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0010408
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0850292
UMLS CUI [2,3]
C0332197
patient is able to give and sign study specific informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
measurable disease, according to recist criteria
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
laboratory parameters and appropriate clearance from anesthesia based on other medical co-morbidities for placement of fiducials; these would include cbc, basic metabolic panel, bun, and creatinine
Description

Laboratory Results Comorbidity | Clearance Anesthesia | Fiducial marker placement | Complete Blood Count | Basic metabolic panel | Blood urea nitrogen measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0009488
UMLS CUI [2,1]
C0449297
UMLS CUI [2,2]
C0002903
UMLS CUI [3]
C3888577
UMLS CUI [4]
C0009555
UMLS CUI [5]
C2237045
UMLS CUI [6]
C0005845
UMLS CUI [7]
C0201976
>= 4 weeks from previous treatment (chemotherapy or radiation) of malignancy
Description

Prior Therapy Malignant Neoplasms | Prior Chemotherapy Malignant Neoplasms | Prior radiation therapy Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0006826
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0006826
ecog performance status of 0-3 as this procedure is minimally invasive and considered palliative in these patients
Description

ECOG performance status | Minimally Invasive Surgical Procedures | Palliative procedure

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0282624
UMLS CUI [3]
C1285158
exclusion
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
any patient with active connective tissue disease such as lupus or dermatomyositis is excluded
Description

Connective Tissue Diseases | Lupus Erythematosus | Dermatomyositis

Data type

boolean

Alias
UMLS CUI [1]
C0009782
UMLS CUI [2]
C0409974
UMLS CUI [3]
C0011633
any patient with active crohn's disease or active ulcerative colitis is excluded
Description

Crohn Disease | Ulcerative Colitis

Data type

boolean

Alias
UMLS CUI [1]
C0010346
UMLS CUI [2]
C0009324
major medical or psychiatric illness, which would prevent completion of treatment or interfere with follow-up is excluded
Description

Disease Major Preventing Treatment completion | Mental disorders Major Preventing Treatment completion | Disease Major Interferes with Follow-up | Mental disorders Major Interfere with Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0580352
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0580352
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C3274571
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0205164
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C3274571
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Similar models

Eligibility Fallopian Tube Cancer NCT01079832

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Malignant Gynecologic Neoplasm
Item
pathologically proven gynecologic malignancy
boolean
C0699889 (UMLS CUI [1])
Target Lesion Cryosurgery Absent | Target Lesion Radiofrequency ablation Absent
Item
no prior cryosurgery or radiofrequency ablation, in target lesion
boolean
C2986546 (UMLS CUI [1,1])
C0010408 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C0850292 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Informed Consent
Item
patient is able to give and sign study specific informed consent
boolean
C0021430 (UMLS CUI [1])
Measurable Disease
Item
measurable disease, according to recist criteria
boolean
C1513041 (UMLS CUI [1])
Laboratory Results Comorbidity | Clearance Anesthesia | Fiducial marker placement | Complete Blood Count | Basic metabolic panel | Blood urea nitrogen measurement | Creatinine measurement, serum
Item
laboratory parameters and appropriate clearance from anesthesia based on other medical co-morbidities for placement of fiducials; these would include cbc, basic metabolic panel, bun, and creatinine
boolean
C1254595 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0449297 (UMLS CUI [2,1])
C0002903 (UMLS CUI [2,2])
C3888577 (UMLS CUI [3])
C0009555 (UMLS CUI [4])
C2237045 (UMLS CUI [5])
C0005845 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
Prior Therapy Malignant Neoplasms | Prior Chemotherapy Malignant Neoplasms | Prior radiation therapy Malignant Neoplasms
Item
>= 4 weeks from previous treatment (chemotherapy or radiation) of malignancy
boolean
C1514463 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
ECOG performance status | Minimally Invasive Surgical Procedures | Palliative procedure
Item
ecog performance status of 0-3 as this procedure is minimally invasive and considered palliative in these patients
boolean
C1520224 (UMLS CUI [1])
C0282624 (UMLS CUI [2])
C1285158 (UMLS CUI [3])
Exclusion Criteria
Item
exclusion
boolean
C0680251 (UMLS CUI [1])
Connective Tissue Diseases | Lupus Erythematosus | Dermatomyositis
Item
any patient with active connective tissue disease such as lupus or dermatomyositis is excluded
boolean
C0009782 (UMLS CUI [1])
C0409974 (UMLS CUI [2])
C0011633 (UMLS CUI [3])
Crohn Disease | Ulcerative Colitis
Item
any patient with active crohn's disease or active ulcerative colitis is excluded
boolean
C0010346 (UMLS CUI [1])
C0009324 (UMLS CUI [2])
Disease Major Preventing Treatment completion | Mental disorders Major Preventing Treatment completion | Disease Major Interferes with Follow-up | Mental disorders Major Interfere with Follow-up
Item
major medical or psychiatric illness, which would prevent completion of treatment or interfere with follow-up is excluded
boolean
C0012634 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0580352 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0580352 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C3274571 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C3274571 (UMLS CUI [4,4])
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