ID

28183

Description

Nelfinavir, a Phase I/Phase II Rectal Cancer Study; ODM derived from: https://clinicaltrials.gov/show/NCT00704600

Link

https://clinicaltrials.gov/show/NCT00704600

Keywords

Versions (1)
  1. 12/27/17 12/27/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 27, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00704600

English

Eligibility Colorectal Cancer NCT00704600

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven adenocarcinoma of the rectum (tumor <15cm from anal verge)
Description

Adenocarcinoma of rectum | Tumor Distance from anal verge

Data type

boolean

Alias
UMLS CUI [1]
C0149978
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1317308
age >= 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
uicc t3-4 n0-2 m0
Description

UICC (tumor staging)

Data type

boolean

Alias
UMLS CUI [1]
C0441914
who performance status 0-2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
less than 10 % weight loss the last 6 months
Description

Weight decreased Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
no recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
Description

Heart Disease Severe Absent | Cardiac Arrhythmia Absent | Congestive heart failure Absent | Myocardial Infarction Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0027051
UMLS CUI [4,2]
C0332197
serum bilirubin = or < 3x normal
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
asat and alat = or < 2,5x normal
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
creatinin clearance >50 ml/min
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
willing and able to comply with the study prescriptions
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
no history of prior pelvic radiotherapy
Description

Radiotherapy to pelvis Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1536155
UMLS CUI [1,2]
C0332197
no known hiv infection
Description

HIV Infection Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0332197
no hemophilia
Description

Hemophilia Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0684275
UMLS CUI [1,2]
C0332197
no concurrent medication that is metabolized by the cyp3a4 isoenzyme (calcium channel blockers, antifungal agents, macrolide antibiotics, gastrointestinal prokinetics, terfenadin, midazolam)
Description

Absence Pharmaceutical Preparations CYP3A4 Metabolized | Calcium Channel Blockers Absent | Antifungal Agents Absent | Macrolide Antibiotics Absent | Prokinetic Agents gastrointestinal Absent | Terfenadine Absent | Midazolam Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C3714798
UMLS CUI [1,4]
C1524026
UMLS CUI [2,1]
C0006684
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0003308
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0003240
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C1268865
UMLS CUI [5,2]
C0521362
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0085173
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0026056
UMLS CUI [7,2]
C0332197
statins should be stopped (except pravastatin and fluvastatin),
Description

Statins To be stopped | Exception Pravastatin | Exception Fluvastatin

Data type

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C1272691
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0085542
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0082608
no concurrent use of st. john's wort (hypericum perforatum)
Description

Hypericum perforatum Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0936242
UMLS CUI [1,2]
C2828389
women should not be pregnant or lactating
Description

Pregnancy Excluded | Breast Feeding Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C2828389
being willing and able to undergo one extra biopsy
Description

Biopsy extra Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1883702
UMLS CUI [1,3]
C1265611
have given written informed consent before patient registration
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the opposite of the above
Description

Inclusion criteria Opposite

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1521805
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Similar models

Eligibility Colorectal Cancer NCT00704600

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of rectum | Tumor Distance from anal verge
Item
histologically proven adenocarcinoma of the rectum (tumor <15cm from anal verge)
boolean
C0149978 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C1317308 (UMLS CUI [2,2])
Age
Item
age >= 18 years
boolean
C0001779 (UMLS CUI [1])
UICC (tumor staging)
Item
uicc t3-4 n0-2 m0
boolean
C0441914 (UMLS CUI [1])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
Weight decreased Percentage
Item
less than 10 % weight loss the last 6 months
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Heart Disease Severe Absent | Cardiac Arrhythmia Absent | Congestive heart failure Absent | Myocardial Infarction Absent
Item
no recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0003811 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Serum total bilirubin measurement
Item
serum bilirubin = or < 3x normal
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
asat and alat = or < 2,5x normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine clearance measurement
Item
creatinin clearance >50 ml/min
boolean
C0373595 (UMLS CUI [1])
Protocol Compliance
Item
willing and able to comply with the study prescriptions
boolean
C0525058 (UMLS CUI [1])
Radiotherapy to pelvis Absent
Item
no history of prior pelvic radiotherapy
boolean
C1536155 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
HIV Infection Absent
Item
no known hiv infection
boolean
C0019693 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Hemophilia Absent
Item
no hemophilia
boolean
C0684275 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Absence Pharmaceutical Preparations CYP3A4 Metabolized | Calcium Channel Blockers Absent | Antifungal Agents Absent | Macrolide Antibiotics Absent | Prokinetic Agents gastrointestinal Absent | Terfenadine Absent | Midazolam Absent
Item
no concurrent medication that is metabolized by the cyp3a4 isoenzyme (calcium channel blockers, antifungal agents, macrolide antibiotics, gastrointestinal prokinetics, terfenadin, midazolam)
boolean
C0332197 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C3714798 (UMLS CUI [1,3])
C1524026 (UMLS CUI [1,4])
C0006684 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0003308 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0003240 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1268865 (UMLS CUI [5,1])
C0521362 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0085173 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0026056 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Statins To be stopped | Exception Pravastatin | Exception Fluvastatin
Item
statins should be stopped (except pravastatin and fluvastatin),
boolean
C0360714 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0085542 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0082608 (UMLS CUI [3,2])
Hypericum perforatum Excluded
Item
no concurrent use of st. john's wort (hypericum perforatum)
boolean
C0936242 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Pregnancy Excluded | Breast Feeding Excluded
Item
women should not be pregnant or lactating
boolean
C0032961 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Biopsy extra Quantity
Item
being willing and able to undergo one extra biopsy
boolean
C0005558 (UMLS CUI [1,1])
C1883702 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Informed Consent
Item
have given written informed consent before patient registration
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Inclusion criteria Opposite
Item
the opposite of the above
boolean
C1512693 (UMLS CUI [1,1])
C1521805 (UMLS CUI [1,2])
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