ID

31402

Description

Taxotere-Enoxaparin-(ENOXA)-Study; ODM derived from: https://clinicaltrials.gov/show/NCT01058759

Link

https://clinicaltrials.gov/show/NCT01058759

Keywords

Versions (1)
  1. 8/19/18 8/19/18 -
Copyright Holder

see clinicaltrials.gov

Uploaded on

August 19, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT01058759

English

Eligibility Non-small Cell Lung Cancer NCT01058759

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
men and women aged 18 and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
locally advanced or metastatic non-small cell lung cancer stage iiib/iv without any previous therapy
Description

Small cell carcinoma of lung; Locally Advanced Malignant Neoplasm | Small cell carcinoma of lung; metastatic qualifier | Tumor stage | previous therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0149925
UMLS CUI [1,2]
C0677984
UMLS CUI [2,1]
C0149925
UMLS CUI [2,2]
C1522484
UMLS CUI [3]
C1300072
UMLS CUI [4]
C2114510
life expectancy at least 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance < 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
appropriate renal and hepatic function
Description

Renal function; Appropriate | Liver function; Appropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C1548787
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C1548787
appropriate hematology
Description

Hematological system; Appropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0279810
UMLS CUI [1,2]
C1548787
no bleeding events within 4 weeks prior to randomization
Description

Hemorrhage; Time

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0040223
no indication for prophylactic or therapeutic anticoagulation therapy
Description

Indication; Anticoagulation Therapy; Therapeutic procedure | Indication; Anticoagulation Therapy; Prophylactic treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0003281
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0003281
UMLS CUI [2,3]
C0199176
appropriate methods of contraception (both: men and women) for women of childbearing potential negative urine pregnancy test within 7 day prior to randomization
Description

Contraceptive methods; Gender | Childbearing Potential; Urine pregnancy test; Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430056
UMLS CUI [2,3]
C0205160
capability for s.c. injection of enoxaparin every 24 hrs
Description

Enoxaparin; Injection of therapeutic agent; Ability

Data type

boolean

Alias
UMLS CUI [1,1]
C0206460
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C0085732
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of cancer other than nsclc
Description

Malignant Neoplasms; Medical History | Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C0007131
known contraindication for enoxaparin e.g. hit,
Description

Medical contraindication; Enoxaparin | Heparin-induced thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0206460
UMLS CUI [2]
C0272285
known contraindication for docetaxel, cisplatin, carboplatin or co-medication
Description

Medical contraindication; docetaxel | Medical contraindication; Cisplatin | Medical contraindication; Concomitant Agent

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0008838
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C2347852
participation in any other clinical trials within 30 days prior to randomization
Description

Study Subject Participation Status; Time

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0040223
any known medical condition that does not allow therapy according to study protocol
Description

Disease; Medical contraindication; Study Protocol; Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C0087111
seizure disorder
Description

Epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C0014544
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Similar models

Eligibility Non-small Cell Lung Cancer NCT01058759

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
men and women aged 18 and older
boolean
C0001779 (UMLS CUI [1])
Small cell carcinoma of lung; Locally Advanced Malignant Neoplasm | Small cell carcinoma of lung; metastatic qualifier | Tumor stage | previous therapy
Item
locally advanced or metastatic non-small cell lung cancer stage iiib/iv without any previous therapy
boolean
C0149925 (UMLS CUI [1,1])
C0677984 (UMLS CUI [1,2])
C0149925 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C1300072 (UMLS CUI [3])
C2114510 (UMLS CUI [4])
Life Expectancy
Item
life expectancy at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance < 1
boolean
C1520224 (UMLS CUI [1])
Renal function; Appropriate | Liver function; Appropriate
Item
appropriate renal and hepatic function
boolean
C0232804 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
Hematological system; Appropriate
Item
appropriate hematology
boolean
C0279810 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
Hemorrhage; Time
Item
no bleeding events within 4 weeks prior to randomization
boolean
C0019080 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Indication; Anticoagulation Therapy; Therapeutic procedure | Indication; Anticoagulation Therapy; Prophylactic treatment
Item
no indication for prophylactic or therapeutic anticoagulation therapy
boolean
C3146298 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0003281 (UMLS CUI [2,2])
C0199176 (UMLS CUI [2,3])
Contraceptive methods; Gender | Childbearing Potential; Urine pregnancy test; Negative
Item
appropriate methods of contraception (both: men and women) for women of childbearing potential negative urine pregnancy test within 7 day prior to randomization
boolean
C0700589 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430056 (UMLS CUI [2,2])
C0205160 (UMLS CUI [2,3])
Enoxaparin; Injection of therapeutic agent; Ability
Item
capability for s.c. injection of enoxaparin every 24 hrs
boolean
C0206460 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms; Medical History | Non-Small Cell Lung Carcinoma
Item
history of cancer other than nsclc
boolean
C0006826 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2])
Medical contraindication; Enoxaparin | Heparin-induced thrombocytopenia
Item
known contraindication for enoxaparin e.g. hit,
boolean
C1301624 (UMLS CUI [1,1])
C0206460 (UMLS CUI [1,2])
C0272285 (UMLS CUI [2])
Medical contraindication; docetaxel | Medical contraindication; Cisplatin | Medical contraindication; Concomitant Agent
Item
known contraindication for docetaxel, cisplatin, carboplatin or co-medication
boolean
C1301624 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0008838 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C2347852 (UMLS CUI [3,2])
Study Subject Participation Status; Time
Item
participation in any other clinical trials within 30 days prior to randomization
boolean
C2348568 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Disease; Medical contraindication; Study Protocol; Therapeutic procedure
Item
any known medical condition that does not allow therapy according to study protocol
boolean
C0012634 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Epilepsy
Item
seizure disorder
boolean
C0014544 (UMLS CUI [1])
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