ID

13368

Description

A Phase I Trial of HDFL48 in Recurrent or Metastatic Colorectal Cancers; ODM derived from: https://clinicaltrials.gov/show/NCT00155558

Link

https://clinicaltrials.gov/show/NCT00155558

Keywords

Versions (1)
  1. 2/9/16 2/9/16 -
Uploaded on

February 9, 2016

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License

Creative Commons BY 4.0
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Eligibility Recurrent or Metastatic Colorectal Cancer NCT00155558

English

Eligibility Recurrent or Metastatic Colorectal Cancer NCT00155558

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically confirmed recurrent or metastatic colorectal adenocarcinoma
Description

colorectal adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1319315
patients are indicated for 5-fu (1st-line after recurrence/metastasis), or have failed 5-fu ,treatment with other schedules
Description

5-fu

Data type

boolean

Alias
UMLS CUI [1]
C0016360
at least one bi-dimensionally measurable lesion(s)
Description

measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
previous c/t, r/t >= 4 weeks
Description

previous c/t, r/t >= 4 weeks

Data type

boolean

kps > 50%
Description

kps

Data type

boolean

Alias
UMLS CUI [1]
C0206065
age >= 18 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
fasting tg > 70 mg/dl (within 7 days)
Description

fasting triglcerides

Data type

boolean

Alias
UMLS CUI [1]
C0583331
wbc >= 3,000/ul or anc >= 1,500/ul
Description

wbc, anc

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0200633
plt >= 75,000/ul
Description

platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0032181
cre<= 1.5 mg/dl
Description

cre

Data type

boolean

Alias
UMLS CUI [1]
C0201976
proteinuria < 1+
Description

proteinuria

Data type

boolean

Alias
UMLS CUI [1]
C0033687
normal t-bil
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
ast/ alt <= 3.5-fold of uln
Description

ast, alt

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
concomitant anticancer therapy or radiotherapy
Description

therapy

Data type

boolean

Alias
UMLS CUI [1]
C0087111
cns metastasis
Description

cns metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0686377
pregnant women
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
patients who have second malignancy
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
symptomatic heart disease (significant arrhythmia, chf or mi within 3 months of entry)
Description

heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
active infection exists
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
extensive liver disease or liver cirrhosis
Description

liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
patients who refuse port-a catheter implantation
Description

port

Data type

boolean

Alias
UMLS CUI [1]
C1608324
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Similar models

Eligibility Recurrent or Metastatic Colorectal Cancer NCT00155558

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
colorectal adenocarcinoma
Item
pathologically confirmed recurrent or metastatic colorectal adenocarcinoma
boolean
C1319315 (UMLS CUI [1])
5-fu
Item
patients are indicated for 5-fu (1st-line after recurrence/metastasis), or have failed 5-fu ,treatment with other schedules
boolean
C0016360 (UMLS CUI [1])
measurable disease
Item
at least one bi-dimensionally measurable lesion(s)
boolean
C1513041 (UMLS CUI [1])
previous c/t, r/t >= 4 weeks
Item
previous c/t, r/t >= 4 weeks
boolean
kps
Item
kps > 50%
boolean
C0206065 (UMLS CUI [1])
age
Item
age >= 18 years
boolean
C0001779 (UMLS CUI [1])
fasting triglcerides
Item
fasting tg > 70 mg/dl (within 7 days)
boolean
C0583331 (UMLS CUI [1])
wbc, anc
Item
wbc >= 3,000/ul or anc >= 1,500/ul
boolean
C0023508 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
platelet count
Item
plt >= 75,000/ul
boolean
C0032181 (UMLS CUI [1])
cre
Item
cre<= 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
proteinuria
Item
proteinuria < 1+
boolean
C0033687 (UMLS CUI [1])
bilirubin
Item
normal t-bil
boolean
C1278039 (UMLS CUI [1])
ast, alt
Item
ast/ alt <= 3.5-fold of uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
therapy
Item
concomitant anticancer therapy or radiotherapy
boolean
C0087111 (UMLS CUI [1])
cns metastasis
Item
cns metastasis
boolean
C0686377 (UMLS CUI [1])
pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
malignancy
Item
patients who have second malignancy
boolean
C0006826 (UMLS CUI [1])
heart disease
Item
symptomatic heart disease (significant arrhythmia, chf or mi within 3 months of entry)
boolean
C0018799 (UMLS CUI [1])
infection
Item
active infection exists
boolean
C0009450 (UMLS CUI [1])
liver disease
Item
extensive liver disease or liver cirrhosis
boolean
C0023895 (UMLS CUI [1])
port
Item
patients who refuse port-a catheter implantation
boolean
C1608324 (UMLS CUI [1])
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