ID

16921

Descripción

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

Palabras clave

Versiones (1)
  1. 14/8/16 14/8/16 -
Subido en

14 de agosto de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00220155

Inglés

Eligibility Colorectal Cancer NCT00220155

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >18 years
Descripción

age

Tipo de datos

boolean

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

colorectal adenocarcinoma

Tipo de datos

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.
Descripción

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

Tipo de datos

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
Descripción

progressive disease

Tipo de datos

boolean

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

previous malignant disease

Tipo de datos

boolean

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

measurable disease

Tipo de datos

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.
Descripción

bone marrow function, hb, platelets, wbc, neutrophiles

Tipo de datos

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
Descripción

bilirubin

Tipo de datos

boolean

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

creatinine

Tipo de datos

boolean

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

uncontrolled medical condition

Tipo de datos

boolean

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

who performance status

Tipo de datos

boolean

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

contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
informed written consent
Descripción

informed written consent

Tipo de datos

boolean

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

pragnancy

Tipo de datos

boolean

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

life expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Descripción

Exclusion Criteria

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

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

Tipo de datos

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).
Descripción

chemotherapy or radiotherapy

Tipo de datos

boolean

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

gemcitabine

Tipo de datos

boolean

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

uncontrolled cerebral metastases

Tipo de datos

boolean

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

Eligibility Colorectal Cancer NCT00220155

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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