ID

23463

Beschrijving

CAPPA-2: Cisplatin Added to Gemcitabine in Poor Performance Advanced NSCLC Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00526643

Link

https://clinicaltrials.gov/show/NCT00526643

Trefwoorden

  1. 05-07-17 05-07-17 -
Geüploaded op

5 juli 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Non-Small Cell Lung Cancer NCT00526643

Eligibility Non-Small Cell Lung Cancer NCT00526643

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed diagnosis of advanced non small cell lung cancer, not amenable to surgical or curative radiation therapy (stage iiib or iv);
Beschrijving

ID.1

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1827320
UMLS CUI [1,3]
C1828386
no prior or concomitant chemotherapy (adjuvant/neoadjuvant chemotherapy permitted if concluded at least one year prior to enrollment);
Beschrijving

ID.2

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0392920
ecog performance status 2;
Beschrijving

ID.3

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
age: > or = 18 and < 70 years;
Beschrijving

ID.4

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy at least 4 weeks;
Beschrijving

ID.5

Datatype

boolean

normal bone marrow, hepatic and renal function defined as: neutrophils > or = 2000/mm3, plt > or = 100,000/mm3, hb > or = 10.0 g/dl, bilirubin > or = 1.5 times the upper normal limit (unl), ast and alt < or = 3 times the unl (5 times in the presence of liver metastases), creatinine within normal limits;
Beschrijving

ID.6

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0232741
signed informed consent.
Beschrijving

ID.7

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
active systemic infections;
Beschrijving

ID.8

Datatype

boolean

Alias
UMLS CUI [1]
C3714514
severe concomitant illness (congestive heart failure, angina pectoris, myocardial infarction within previous 6 months, cardiac arrhythmias under treatment, severe arterial hypertension, severe or uncontrolled diabetes mellitus);
Beschrijving

ID.9

Datatype

boolean

Alias
UMLS CUI [1]
C0012634
inadequate hepatic or renal function;
Beschrijving

ID.10

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0022658
radiation therapy ongoing or concluded within two weeks prior to enrollment;
Beschrijving

ID.11

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
symptomatic cerebral metastases;
Beschrijving

ID.12

Datatype

boolean

Alias
UMLS CUI [1]
C0555278
previous chemotherapy for advanced disease;
Beschrijving

ID.13

Datatype

boolean

Alias
UMLS CUI [1]
C0278940
any condition that would, in the investigator's opinion, limit the patients ability to provide informed consent or to comply with study procedures;
Beschrijving

ID.14

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
pregnant or nursing females;
Beschrijving

ID.15

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
any malignancy within the past 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
Beschrijving

ID.16

Datatype

boolean

Alias
UMLS CUI [1]
C0006826

Similar models

Eligibility Non-Small Cell Lung Cancer NCT00526643

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
histologically or cytologically confirmed diagnosis of advanced non small cell lung cancer, not amenable to surgical or curative radiation therapy (stage iiib or iv);
boolean
C0007131 (UMLS CUI [1,1])
C1827320 (UMLS CUI [1,2])
C1828386 (UMLS CUI [1,3])
ID.2
Item
no prior or concomitant chemotherapy (adjuvant/neoadjuvant chemotherapy permitted if concluded at least one year prior to enrollment);
boolean
C0087111 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
ID.3
Item
ecog performance status 2;
boolean
C1520224 (UMLS CUI [1])
ID.4
Item
age: > or = 18 and < 70 years;
boolean
C0001779 (UMLS CUI [1])
ID.5
Item
life expectancy at least 4 weeks;
boolean
ID.6
Item
normal bone marrow, hepatic and renal function defined as: neutrophils > or = 2000/mm3, plt > or = 100,000/mm3, hb > or = 10.0 g/dl, bilirubin > or = 1.5 times the upper normal limit (unl), ast and alt < or = 3 times the unl (5 times in the presence of liver metastases), creatinine within normal limits;
boolean
C0005953 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0232741 (UMLS CUI [1,3])
ID.7
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.8
Item
active systemic infections;
boolean
C3714514 (UMLS CUI [1])
ID.9
Item
severe concomitant illness (congestive heart failure, angina pectoris, myocardial infarction within previous 6 months, cardiac arrhythmias under treatment, severe arterial hypertension, severe or uncontrolled diabetes mellitus);
boolean
C0012634 (UMLS CUI [1])
ID.10
Item
inadequate hepatic or renal function;
boolean
C0086565 (UMLS CUI [1,1])
C0022658 (UMLS CUI [1,2])
ID.11
Item
radiation therapy ongoing or concluded within two weeks prior to enrollment;
boolean
C1522449 (UMLS CUI [1])
ID.12
Item
symptomatic cerebral metastases;
boolean
C0555278 (UMLS CUI [1])
ID.13
Item
previous chemotherapy for advanced disease;
boolean
C0278940 (UMLS CUI [1])
ID.14
Item
any condition that would, in the investigator's opinion, limit the patients ability to provide informed consent or to comply with study procedures;
boolean
C0004936 (UMLS CUI [1])
ID.15
Item
pregnant or nursing females;
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
ID.16
Item
any malignancy within the past 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
boolean
C0006826 (UMLS CUI [1])

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