ID

17228

Description

Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR; ODM derived from: https://clinicaltrials.gov/show/NCT00240682

Link

https://clinicaltrials.gov/show/NCT00240682

Keywords

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

September 1, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Skin Diseases NCT00240682

English

Eligibility Skin Diseases NCT00240682

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological scc of the skin expressing (ihc) moderately or highly the egfr (++ and +++, on a semi-quantitative scale).
Description

Squamous cell carcinoma of skin expressing moderately or highly the egfr

Data type

boolean

Alias
UMLS CUI [1]
C0553723
UMLS CUI [2,1]
C0034802
UMLS CUI [2,2]
C0021044
locally advanced or metastatic scc of the skin not suitable for local surgery with documented progression.
Description

locally advanced or metastatic scc of the skin not suitable for local surgery with documented progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0553723
UMLS CUI [1,2]
C0677984
UMLS CUI [2]
C2063963
UMLS CUI [3,1]
C1096417
UMLS CUI [3,2]
C1548788
UMLS CUI [4]
C0242656
presence of at least one measurable target lesion by recist criteria.
Description

measurable lesion

Data type

boolean

Alias
UMLS CUI [1]
C1513041
at least one lesion accessible to biopsies.
Description

lesion accessible to biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0856310
ecog performance status < 2.
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 3 months.
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
age > 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
normal hematological (neutrophils > 1.5x109 cells/l, platelets > 100x109 cells/l), hepatic (bilirubin < 1.5 times the upper limit of the normal range (uln); alkaline phosphatase and transaminases < 5 x unl in case of hepatic metastases or < 2.5 x unl in absence of hepatic metastases) and renal (serum creatinine < 150 micromol/l) functions.
Description

hematological, hepatic and renal function

Data type

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0201913
UMLS CUI [4]
C0201850
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201976
written informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
in case of second tumor,excepted carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma, the possibility for including a patient may be discussed with the principal investigator.
Description

Other malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
prior radiotherapy < 1 month.
Description

radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
prior therapy with agent targeting egfr
Description

Agent targeting egfr

Data type

boolean

Alias
UMLS CUI [1]
C1443775
UMLS CUI [2]
C4055105
unstable systemic diseases or active uncontrolled infections.
Description

systemic diseases or active uncontrolled infection

Data type

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2]
C0009450
patients (male and female) not using effective contraception if of reproductive potential.
Description

Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
females pregnant or lactating. women of child bearing potential must have a negative serum or urine pregnancy test prior to start each cycle of treatment.
Description

pregnant or lactating, pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032976
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Similar models

Eligibility Skin Diseases NCT00240682

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of skin expressing moderately or highly the egfr
Item
histological scc of the skin expressing (ihc) moderately or highly the egfr (++ and +++, on a semi-quantitative scale).
boolean
C0553723 (UMLS CUI [1])
C0034802 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
locally advanced or metastatic scc of the skin not suitable for local surgery with documented progression
Item
locally advanced or metastatic scc of the skin not suitable for local surgery with documented progression.
boolean
C0553723 (UMLS CUI [1,1])
C0677984 (UMLS CUI [1,2])
C2063963 (UMLS CUI [2])
C1096417 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4])
measurable lesion
Item
presence of at least one measurable target lesion by recist criteria.
boolean
C1513041 (UMLS CUI [1])
lesion accessible to biopsy
Item
at least one lesion accessible to biopsies.
boolean
C0856310 (UMLS CUI [1])
ECOG
Item
ecog performance status < 2.
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
life expectancy > 3 months.
boolean
C0023671 (UMLS CUI [1])
Age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
hematological, hepatic and renal function
Item
normal hematological (neutrophils > 1.5x109 cells/l, platelets > 100x109 cells/l), hepatic (bilirubin < 1.5 times the upper limit of the normal range (uln); alkaline phosphatase and transaminases < 5 x unl in case of hepatic metastases or < 2.5 x unl in absence of hepatic metastases) and renal (serum creatinine < 150 micromol/l) functions.
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0201913 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Other malignancy
Item
in case of second tumor,excepted carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma, the possibility for including a patient may be discussed with the principal investigator.
boolean
C0006826 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
chemotherapy
Item
prior chemotherapy
boolean
C0392920 (UMLS CUI [1])
radiotherapy
Item
prior radiotherapy < 1 month.
boolean
C1522449 (UMLS CUI [1])
Agent targeting egfr
Item
prior therapy with agent targeting egfr
boolean
C1443775 (UMLS CUI [1])
C4055105 (UMLS CUI [2])
systemic diseases or active uncontrolled infection
Item
unstable systemic diseases or active uncontrolled infections.
boolean
C0442893 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
Contraception
Item
patients (male and female) not using effective contraception if of reproductive potential.
boolean
C0700589 (UMLS CUI [1])
pregnant or lactating, pregnancy test
Item
females pregnant or lactating. women of child bearing potential must have a negative serum or urine pregnancy test prior to start each cycle of treatment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032976 (UMLS CUI [3])
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