ID

16921

Description

Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00220155

Link

https://clinicaltrials.gov/show/NCT00220155

Keywords

Versions (1)
  1. 8/14/16 8/14/16 -
Uploaded on

August 14, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00220155

English

Eligibility Colorectal Cancer NCT00220155

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >18 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histologically proven colorectal adenocarcinoma.
Description

colorectal adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1319315
locally advanced (inoperable) or metastatic colorectal carcinoma treated with at least one prior chemotherapy regimen.
Description

locally advanced (inoperable) or metastatic colorectal carcinoma treated with at least one prior chemotherapy regimen.

Data type

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0677984
UMLS CUI [2,1]
C0009402
UMLS CUI [2,2]
C0027627
UMLS CUI [3]
C1514457
progressive disease documented by ct either during or within 3 months of completion of previous chemotherapy
Description

progressive disease

Data type

boolean

Alias
UMLS CUI [1]
C1335499
no previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix.
Description

previous malignant disease

Data type

boolean

Alias
UMLS CUI [1]
C0260455
unidimensional measurable disease as assessed by ct.
Description

measurable disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0040405
adequate bone marrow function; hb >10g/dl, platelets >100 x109/l, wbc >3x109/l, neut >1.5x109/l.
Description

bone marrow function, hb, platelets, wbc, neutrophiles

Data type

boolean

Alias
UMLS CUI [1]
C0005953
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0005821
UMLS CUI [4]
C0023508
UMLS CUI [5]
C0200633
adequate liver function: serum bilirubin <1.5 x upper limit of normal
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
adequate renal function: serum creatinine < 0.11 mmol/l
Description

creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
no concurrent uncontrolled medical conditions
Description

uncontrolled medical condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
who performance status 0,1 or 2
Description

who performance status

Data type

boolean

Alias
UMLS CUI [1]
C1298650
adequate contraceptive precautions, if appropriate
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
informed written consent
Description

informed written consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
negative pregnancy test in women of child bearing age
Description

pragnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
life expectancy > 3 months
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
medical or psychiatric condition that comprise the patient's ability to take informed consent.
Description

medical or psychiatric condition that comprise the patient's ability to take informed consent.

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0021430
patients within 4 weeks of chemotherapy or radiotherapy (6 weeks for nitrosureas or mitomycin c).
Description

chemotherapy or radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
previous treatment with gemcitabine.
Description

gemcitabine

Data type

boolean

Alias
UMLS CUI [1]
C0045093
patients with uncontrolled cerebral metastases.
Description

uncontrolled cerebral metastases

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205318
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Similar models

Eligibility Colorectal Cancer NCT00220155

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age >18 years
boolean
C0001779 (UMLS CUI [1])
colorectal adenocarcinoma
Item
histologically proven colorectal adenocarcinoma.
boolean
C0011900 (UMLS CUI [1,1])
C1319315 (UMLS CUI [1,2])
locally advanced (inoperable) or metastatic colorectal carcinoma treated with at least one prior chemotherapy regimen.
Item
locally advanced (inoperable) or metastatic colorectal carcinoma treated with at least one prior chemotherapy regimen.
boolean
C0009402 (UMLS CUI [1,1])
C0677984 (UMLS CUI [1,2])
C0009402 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3])
progressive disease
Item
progressive disease documented by ct either during or within 3 months of completion of previous chemotherapy
boolean
C1335499 (UMLS CUI [1])
previous malignant disease
Item
no previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix.
boolean
C0260455 (UMLS CUI [1])
measurable disease
Item
unidimensional measurable disease as assessed by ct.
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
bone marrow function, hb, platelets, wbc, neutrophiles
Item
adequate bone marrow function; hb >10g/dl, platelets >100 x109/l, wbc >3x109/l, neut >1.5x109/l.
boolean
C0005953 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0200633 (UMLS CUI [5])
bilirubin
Item
adequate liver function: serum bilirubin <1.5 x upper limit of normal
boolean
C1278039 (UMLS CUI [1])
creatinine
Item
adequate renal function: serum creatinine < 0.11 mmol/l
boolean
C0201976 (UMLS CUI [1])
uncontrolled medical condition
Item
no concurrent uncontrolled medical conditions
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
who performance status
Item
who performance status 0,1 or 2
boolean
C1298650 (UMLS CUI [1])
contraception
Item
adequate contraceptive precautions, if appropriate
boolean
C0700589 (UMLS CUI [1])
informed written consent
Item
informed written consent
boolean
C0021430 (UMLS CUI [1])
pragnancy
Item
negative pregnancy test in women of child bearing age
boolean
C0032961 (UMLS CUI [1])
life expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
medical or psychiatric condition that comprise the patient's ability to take informed consent.
Item
medical or psychiatric condition that comprise the patient's ability to take informed consent.
boolean
C0009488 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
chemotherapy or radiotherapy
Item
patients within 4 weeks of chemotherapy or radiotherapy (6 weeks for nitrosureas or mitomycin c).
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
gemcitabine
Item
previous treatment with gemcitabine.
boolean
C0045093 (UMLS CUI [1])
uncontrolled cerebral metastases
Item
patients with uncontrolled cerebral metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
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