ID

37699

Description

Adjuvant Radiation for High Risk Bladder Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01954173

Link

https://clinicaltrials.gov/show/NCT01954173

Keywords

Versions (1)
  1. 8/18/19 8/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Bladder Cancer NCT01954173

English

Eligibility Bladder Cancer NCT01954173

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologic diagnosis of urothelial or squamous cell carcinoma of the bladder
Description

Transitional cell carcinoma of bladder | Bladder Squamous Cell Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0279680
UMLS CUI [2]
C0279681
patients must have undergone cystectomy (total cystectomy, radical cystectomy +/-
Description

Cystectomy | Complete cystectomy

Data type

boolean

Alias
UMLS CUI [1]
C0010651
UMLS CUI [2]
C0194401
pelvic lymph node dissection) with no evidence of macroscopic residual disease
Description

Pelvic lymphadenectomy | Residual disease Macroscopic Absent

Data type

boolean

Alias
UMLS CUI [1]
C0193883
UMLS CUI [2,1]
C0543478
UMLS CUI [2,2]
C0439806
UMLS CUI [2,3]
C0332197
eastern cooperative oncology group (ecog)/zubrod performance status of 0-2
Description

ECOG performance status | Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C3714786
patients treated with simple cystectomy with macroscopically negative margins are eligible for this study
Description

Simple cystectomy | Negative Surgical Margin Macroscopic

Data type

boolean

Alias
UMLS CUI [1]
C0401447
UMLS CUI [2,1]
C1709157
UMLS CUI [2,2]
C0439806
clinical t-stage (prior to systemic therapy, if applicable) ≥ t3a and/or positive lymph nodes by transurethral resection of bladder tumor (turbt)/magnetic resonance imaging (mri)/computed tomography (ct)/positron emission tomography (pet)-ct or pathologic t-stage ≥ t3a and/or positive lymph nodes
Description

Status pre- Systemic therapy | TNM clinical staging | Lymph nodes positive | Transurethral resection of bladder neoplasm | Magnetic Resonance Imaging | CT | PET/CT | Pathologic TNM stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0332152
UMLS CUI [1,2]
C1515119
UMLS CUI [2]
C3258246
UMLS CUI [3]
C0746319
UMLS CUI [4]
C0401496
UMLS CUI [5]
C0024485
UMLS CUI [6]
C0040405
UMLS CUI [7]
C1699633
UMLS CUI [8]
C1319019
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with metastatic disease outside of the pelvis
Description

Neoplasm Metastasis | Exception Pelvis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030797
prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
Description

Invasive cancer | Exception Skin carcinoma | Exception Disease Free Duration

Data type

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
UMLS CUI [3,4]
C0449238
prior radiation therapy to the pelvis
Description

Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1]
C1536155
patients with active inflammatory bowel disease
Description

Inflammatory Bowel Disease

Data type

boolean

Alias
UMLS CUI [1]
C0021390
severe acute co-morbidity, defined as follows:
Description

Comorbidity Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months
Description

Angina, Unstable | Congestive heart failure Hospitalization Required

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1708385
transmural myocardial infarction within the last 6 months
Description

Transmural myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C1400513
acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Description

Bacterial Infections | Mycoses | Requirement Antibiotics Intravenous

Data type

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2]
C0026946
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0003232
UMLS CUI [3,3]
C1522726
chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
Description

Chronic obstructive pulmonary disease exacerbation Hospitalization Required | Chronic obstructive pulmonary disease exacerbation Excludes Investigational Therapy | Respiration Disorder Hospitalization Required | Respiration Disorder Excludes Investigational Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3508933
UMLS CUI [1,2]
C1708385
UMLS CUI [2,1]
C3508933
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0949266
UMLS CUI [3,1]
C0035204
UMLS CUI [3,2]
C1708385
UMLS CUI [4,1]
C0035204
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0949266
acquired immune deficiency syndrome (aids) based upon current centers for disease control and prevention (cdc) definition; note, however, that human immunodeficiency virus (hiv) testing is not required for entry into this protocol; the need to exclude patients with aids from this protocol is necessary because the treatment involved in this protocol may be significantly immunosuppressive; protocol-specific requirements may also exclude immunocompromised patients
Description

AIDS | Immunocompromised patients

Data type

boolean

Alias
UMLS CUI [1]
C0001175
UMLS CUI [2]
C0085393
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Similar models

Eligibility Bladder Cancer NCT01954173

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Transitional cell carcinoma of bladder | Bladder Squamous Cell Carcinoma
Item
pathologic diagnosis of urothelial or squamous cell carcinoma of the bladder
boolean
C0279680 (UMLS CUI [1])
C0279681 (UMLS CUI [2])
Cystectomy | Complete cystectomy
Item
patients must have undergone cystectomy (total cystectomy, radical cystectomy +/-
boolean
C0010651 (UMLS CUI [1])
C0194401 (UMLS CUI [2])
Pelvic lymphadenectomy | Residual disease Macroscopic Absent
Item
pelvic lymph node dissection) with no evidence of macroscopic residual disease
boolean
C0193883 (UMLS CUI [1])
C0543478 (UMLS CUI [2,1])
C0439806 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
ECOG performance status | Zubrod Performance Status
Item
eastern cooperative oncology group (ecog)/zubrod performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
C3714786 (UMLS CUI [2])
Simple cystectomy | Negative Surgical Margin Macroscopic
Item
patients treated with simple cystectomy with macroscopically negative margins are eligible for this study
boolean
C0401447 (UMLS CUI [1])
C1709157 (UMLS CUI [2,1])
C0439806 (UMLS CUI [2,2])
Status pre- Systemic therapy | TNM clinical staging | Lymph nodes positive | Transurethral resection of bladder neoplasm | Magnetic Resonance Imaging | CT | PET/CT | Pathologic TNM stage
Item
clinical t-stage (prior to systemic therapy, if applicable) ≥ t3a and/or positive lymph nodes by transurethral resection of bladder tumor (turbt)/magnetic resonance imaging (mri)/computed tomography (ct)/positron emission tomography (pet)-ct or pathologic t-stage ≥ t3a and/or positive lymph nodes
boolean
C0332152 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2])
C0746319 (UMLS CUI [3])
C0401496 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0040405 (UMLS CUI [6])
C1699633 (UMLS CUI [7])
C1319019 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis | Exception Pelvis
Item
patients with metastatic disease outside of the pelvis
boolean
C0027627 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0030797 (UMLS CUI [2,2])
Invasive cancer | Exception Skin carcinoma | Exception Disease Free Duration
Item
prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
Radiotherapy to pelvis
Item
prior radiation therapy to the pelvis
boolean
C1536155 (UMLS CUI [1])
Inflammatory Bowel Disease
Item
patients with active inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])
Comorbidity Severe
Item
severe acute co-morbidity, defined as follows:
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Angina, Unstable | Congestive heart failure Hospitalization Required
Item
unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months
boolean
C0002965 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1708385 (UMLS CUI [2,2])
Transmural myocardial infarction
Item
transmural myocardial infarction within the last 6 months
boolean
C1400513 (UMLS CUI [1])
Bacterial Infections | Mycoses | Requirement Antibiotics Intravenous
Item
acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
boolean
C0004623 (UMLS CUI [1])
C0026946 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0003232 (UMLS CUI [3,2])
C1522726 (UMLS CUI [3,3])
Chronic obstructive pulmonary disease exacerbation Hospitalization Required | Chronic obstructive pulmonary disease exacerbation Excludes Investigational Therapy | Respiration Disorder Hospitalization Required | Respiration Disorder Excludes Investigational Therapy
Item
chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
boolean
C3508933 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
C3508933 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0949266 (UMLS CUI [2,3])
C0035204 (UMLS CUI [3,1])
C1708385 (UMLS CUI [3,2])
C0035204 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0949266 (UMLS CUI [4,3])
AIDS | Immunocompromised patients
Item
acquired immune deficiency syndrome (aids) based upon current centers for disease control and prevention (cdc) definition; note, however, that human immunodeficiency virus (hiv) testing is not required for entry into this protocol; the need to exclude patients with aids from this protocol is necessary because the treatment involved in this protocol may be significantly immunosuppressive; protocol-specific requirements may also exclude immunocompromised patients
boolean
C0001175 (UMLS CUI [1])
C0085393 (UMLS CUI [2])
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