ID

24746

Beskrivning

Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00592007

Länk

https://clinicaltrials.gov/show/NCT00592007

Nyckelord

Versioner (1)
  1. 2017-08-16 2017-08-16 -
Uppladdad den

16 augusti 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Carcinoma NCT00592007

Engelsk

Eligibility Non Small Cell Lung Carcinoma NCT00592007

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
estrogen or progesterone receptor positive stage iiib/iv non-small cell lung cancer
Beskrivning

Non-Small Cell Lung Carcinoma Estrogen receptor positive TNM clinical staging | Non-Small Cell Lung Carcinoma Progesterone receptor positive TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0279754
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0279759
UMLS CUI [2,3]
C3258246
eligible patients will have stable disease on erlotinib monotherapy at fda- approved doses after a minimum duration of erlotinib therapy of 2 months
Beskrivning

Erlotinib Dose Approved | Stable Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1135135
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205540
UMLS CUI [2]
C0677946
18 years or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status ≤2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function requirements
Beskrivning

Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
adequate coagulation function
Beskrivning

Coagulation function measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C3516400
postmenopausal status in female patients is required and is defined as no menstrual periods for 12 month or surgical menopause
Beskrivning

Postmenopausal state | Amenorrhea Duration | Surgical menopause

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3]
C0740421
all patients must sign a written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast-feeding women will not be entered on this study
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who are currently receiving another investigational drugs
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
patients who are currently receiving other anti-cancer agents.
Beskrivning

Antineoplastic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0003392
hormone replacement therapy will not be allowed and have to be stopped 1 month prior to entry into the study
Beskrivning

Hormone replacement therapy To be stopped

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0282402
UMLS CUI [1,2]
C1272691
patients who have an uncontrolled infection.
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
patients receiving less than 100mg/day of erlotinib
Beskrivning

Erlotinib U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1135135
UMLS CUI [1,2]
C0456683
patients with evidence of progression after 2 months of erlotinib monotherapy.
Beskrivning

Erlotinib | Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1]
C1135135
UMLS CUI [2]
C0242656
patients with a history of bleeding diathesis (i.e., disseminated intravascular coagulation [dic], clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy).
Beskrivning

Bleeding tendency | Disseminated Intravascular Coagulation | Clotting factor deficiency | Anticoagulant therapy | Exception Antiplatelet therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0012739
UMLS CUI [3]
C0272315
UMLS CUI [4]
C0150457
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1096021
patients with a history of hypersensitivity to active or inactive excipients of fulvestrant (i.e. castor oil or mannitol).
Beskrivning

Hypersensitivity Fulvestrant Excipient Active | Hypersensitivity Fulvestrant Excipient Inactive | Castor oil allergy | Mannitol allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0935916
UMLS CUI [1,3]
C0015237
UMLS CUI [1,4]
C0205177
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0935916
UMLS CUI [2,3]
C0015237
UMLS CUI [2,4]
C1705605
UMLS CUI [3]
C0571232
UMLS CUI [4]
C0571922
patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
Beskrivning

Safety Monitoring Compliance behavior Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036043
UMLS CUI [1,2]
C1516647
UMLS CUI [1,3]
C1321605
UMLS CUI [1,4]
C0439801
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Similar models

Eligibility Non Small Cell Lung Carcinoma NCT00592007

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Estrogen receptor positive TNM clinical staging | Non-Small Cell Lung Carcinoma Progesterone receptor positive TNM clinical staging
Item
estrogen or progesterone receptor positive stage iiib/iv non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0007131 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
Erlotinib Dose Approved | Stable Disease
Item
eligible patients will have stable disease on erlotinib monotherapy at fda- approved doses after a minimum duration of erlotinib therapy of 2 months
boolean
C1135135 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205540 (UMLS CUI [1,3])
C0677946 (UMLS CUI [2])
Age
Item
18 years or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status ≤2
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function requirements
boolean
C0678852 (UMLS CUI [1])
Coagulation function measurement
Item
adequate coagulation function
boolean
C3516400 (UMLS CUI [1])
Postmenopausal state | Amenorrhea Duration | Surgical menopause
Item
postmenopausal status in female patients is required and is defined as no menstrual periods for 12 month or surgical menopause
boolean
C0232970 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0740421 (UMLS CUI [3])
Informed Consent
Item
all patients must sign a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women will not be entered on this study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
patients who are currently receiving another investigational drugs
boolean
C0013230 (UMLS CUI [1])
Antineoplastic Agents
Item
patients who are currently receiving other anti-cancer agents.
boolean
C0003392 (UMLS CUI [1])
Hormone replacement therapy To be stopped
Item
hormone replacement therapy will not be allowed and have to be stopped 1 month prior to entry into the study
boolean
C0282402 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Communicable Disease Uncontrolled
Item
patients who have an uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Erlotinib U/day
Item
patients receiving less than 100mg/day of erlotinib
boolean
C1135135 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Erlotinib | Disease Progression
Item
patients with evidence of progression after 2 months of erlotinib monotherapy.
boolean
C1135135 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Bleeding tendency | Disseminated Intravascular Coagulation | Clotting factor deficiency | Anticoagulant therapy | Exception Antiplatelet therapy
Item
patients with a history of bleeding diathesis (i.e., disseminated intravascular coagulation [dic], clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy).
boolean
C1458140 (UMLS CUI [1])
C0012739 (UMLS CUI [2])
C0272315 (UMLS CUI [3])
C0150457 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C1096021 (UMLS CUI [5,2])
Hypersensitivity Fulvestrant Excipient Active | Hypersensitivity Fulvestrant Excipient Inactive | Castor oil allergy | Mannitol allergy
Item
patients with a history of hypersensitivity to active or inactive excipients of fulvestrant (i.e. castor oil or mannitol).
boolean
C0020517 (UMLS CUI [1,1])
C0935916 (UMLS CUI [1,2])
C0015237 (UMLS CUI [1,3])
C0205177 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0935916 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C1705605 (UMLS CUI [2,4])
C0571232 (UMLS CUI [3])
C0571922 (UMLS CUI [4])
Safety Monitoring Compliance behavior Limited
Item
patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
boolean
C0036043 (UMLS CUI [1,1])
C1516647 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
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