ID

21997

Description

Gefitinib With or Without Simvastatin in Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00452244

Lien

https://clinicaltrials.gov/show/NCT00452244

Mots-clés

Versions (1)
  1. 14/05/2017 14/05/2017 -
Téléchargé le

14 mai 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00452244

Anglais

Eligibility Lung Cancer NCT00452244

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologic or cytologic diagnosis of nsclc
Description

nsclc

Type de données

boolean

Alias
UMLS CUI [1]
C0007131
2. stage iv or selected stage iiib (with positive pleural effusion or multiple ipsilateral lung nodules) according to the american joint committee on cancer (ajcc).
Description

nsclc ajcc tumor stage, pleural effusion, multiple lung nodules

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1300072
UMLS CUI [1,3]
C0441915
UMLS CUI [1,4]
C0032227
UMLS CUI [1,5]
C0748164
3. previously treated with at least one platinum-based chemotherapy.
Description

platinum-based chemotherapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C3536920
4. before study entry, a minimum of 21 days must have elapsed since any prior chemotherapy.
Description

prior chemotherapy

Type de données

boolean

Alias
UMLS CUI [1]
C1514457
5. prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
Description

prior radiotherapy

Type de données

boolean

Alias
UMLS CUI [1]
C0279134
6. no other forms of cancer therapy, such as radiation, immunotherapy for at least 2 weeks before the enrollment in study.
Description

other cancer therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0920425
7. performance status of 0-3 on the ecog criteria.
Description

ecog

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
8. at least one unidimensional measurable lesion meeting response evaluation criteria in solid tumors (recist. 2000).- estimated life expectancy of at least 8 weeks.
Description

response evaluation criteria in solid tumors, life expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C1709926
UMLS CUI [2]
C0023671
9. patient compliance that allow adequate follow-up.
Description

follow-up compliance

Type de données

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1321605
10. adequate hematologic (anc count ≥ 1,000/ul, platelet count ≥ 150,000/mm3), hepatic (bilirubin level≤1.5 mg/dl, ast/alt ≤ 80 iu/l), and renal (creatinine concentration ≤ 1.5 mg/dl) function.
Description

hematologic, hepatic, renal function

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0948762
UMLS CUI [1,3]
C0005821
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C1278039
UMLS CUI [2,3]
C0201899
UMLS CUI [2,4]
C0201836
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0201976
11. informed consent from patient or patient's relative.
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
12. males or females at least 18 years of age.
Description

age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
13. if female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [iud], birth control pills, or barrier device) during and for 3 months after trial. if male, use of an approved contraceptive method during the study and 3 months afterwards. females with childbearing potential must have a urine negative hcg test within 7 days prior to the study enrollment.
Description

effective contraception, pregnancy test

Type de données

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0032976
14. no concomitant prescriptions including cyclosporin a, valproic acid, phenobarbital, phenytoin, ketoconazole.
Description

concomitant medication

Type de données

boolean

Alias
UMLS CUI [1]
C2347852
15. patients with brain metastasis are allowed unless there were clinically significant neurological symptoms or signs
Description

brain metastasis neurological symptoms

Type de données

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0235031
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence of small-cell lung cancer alone or with nsclc- unresolved chronic toxic effects from previous anticancer therapy
Description

small-cell lung cancer, nsclc cancer therapy toxic effects

Type de données

boolean

Alias
UMLS CUI [1]
C0149925
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0920425
UMLS CUI [2,3]
C0600688
2. known severe hypersensitivity to gefitinib or any of the tablet excipients
Description

gefitinib hypersensitivity

Type de données

boolean

Alias
UMLS CUI [1,1]
C1122962
UMLS CUI [1,2]
C0020517
3. inability to swallow tablets
Description

swallow tablets

Type de données

boolean

Alias
UMLS CUI [1,1]
C0566355
UMLS CUI [1,2]
C0039225
4. other coexisting malignant disease (apart from basal-cell carcinoma)
Description

other malignancy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
5. more than three previous chemotherapy regimens for nsclc
Description

prior chemotherapy for nsclc

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
6. previous treatment with an experimental agent of which the main mechanism of action is inhibition of epidermal growth factor receptor or its associated tyrosine kinase
Description

experimental drug egfr inhibitor

Type de données

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1443775
7. concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or st john's wort; severe or uncontrolled systemic disease; clinically active interstitial lung disease (except uncomplicated lymphangitic carcinomatosis) pregnancy; and breastfeeding.
Description

phenytoin, carbamazepine, rifampicin, barbiturates, st johns wort, systemic disease, interstitial lung disease, pregnancy, breast feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0031507
UMLS CUI [2]
C0006949
UMLS CUI [3]
C0035608
UMLS CUI [4]
C0004745
UMLS CUI [5]
C0936242
UMLS CUI [6]
C0442893
UMLS CUI [7]
C0206062
UMLS CUI [8]
C0032961
UMLS CUI [9]
C0006147
8. mi within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia
Description

heart diseases

Type de données

boolean

Alias
UMLS CUI [1]
C0018799
9. serious concomitant infection including post obstructive pneumonia
Description

infections

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
10. major surgery other than biopsy within the past two weeks.
Description

major surgery

Type de données

boolean

Alias
UMLS CUI [1]
C0679637
11. pregnant or breast-feeding.
Description

pregnancy, breast feeding

Type de données

boolean

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

Eligibility Lung Cancer NCT00452244

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
nsclc
Item
1. histologic or cytologic diagnosis of nsclc
boolean
C0007131 (UMLS CUI [1])
nsclc ajcc tumor stage, pleural effusion, multiple lung nodules
Item
2. stage iv or selected stage iiib (with positive pleural effusion or multiple ipsilateral lung nodules) according to the american joint committee on cancer (ajcc).
boolean
C0007131 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C0441915 (UMLS CUI [1,3])
C0032227 (UMLS CUI [1,4])
C0748164 (UMLS CUI [1,5])
platinum-based chemotherapy
Item
3. previously treated with at least one platinum-based chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C3536920 (UMLS CUI [1,2])
prior chemotherapy
Item
4. before study entry, a minimum of 21 days must have elapsed since any prior chemotherapy.
boolean
C1514457 (UMLS CUI [1])
prior radiotherapy
Item
5. prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
boolean
C0279134 (UMLS CUI [1])
other cancer therapy
Item
6. no other forms of cancer therapy, such as radiation, immunotherapy for at least 2 weeks before the enrollment in study.
boolean
C0920425 (UMLS CUI [1])
ecog
Item
7. performance status of 0-3 on the ecog criteria.
boolean
C1520224 (UMLS CUI [1])
response evaluation criteria in solid tumors, life expectancy
Item
8. at least one unidimensional measurable lesion meeting response evaluation criteria in solid tumors (recist. 2000).- estimated life expectancy of at least 8 weeks.
boolean
C1709926 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
follow-up compliance
Item
9. patient compliance that allow adequate follow-up.
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
hematologic, hepatic, renal function
Item
10. adequate hematologic (anc count ≥ 1,000/ul, platelet count ≥ 150,000/mm3), hepatic (bilirubin level≤1.5 mg/dl, ast/alt ≤ 80 iu/l), and renal (creatinine concentration ≤ 1.5 mg/dl) function.
boolean
C0221130 (UMLS CUI [1,1])
C0948762 (UMLS CUI [1,2])
C0005821 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C1278039 (UMLS CUI [2,2])
C0201899 (UMLS CUI [2,3])
C0201836 (UMLS CUI [2,4])
C0232804 (UMLS CUI [3,1])
C0201976 (UMLS CUI [3,2])
informed consent
Item
11. informed consent from patient or patient's relative.
boolean
C0021430 (UMLS CUI [1])
age
Item
12. males or females at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
effective contraception, pregnancy test
Item
13. if female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [iud], birth control pills, or barrier device) during and for 3 months after trial. if male, use of an approved contraceptive method during the study and 3 months afterwards. females with childbearing potential must have a urine negative hcg test within 7 days prior to the study enrollment.
boolean
C0700589 (UMLS CUI [1])
C0032976 (UMLS CUI [2])
concomitant medication
Item
14. no concomitant prescriptions including cyclosporin a, valproic acid, phenobarbital, phenytoin, ketoconazole.
boolean
C2347852 (UMLS CUI [1])
brain metastasis neurological symptoms
Item
15. patients with brain metastasis are allowed unless there were clinically significant neurological symptoms or signs
boolean
C0220650 (UMLS CUI [1,1])
C0235031 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
small-cell lung cancer, nsclc cancer therapy toxic effects
Item
1. presence of small-cell lung cancer alone or with nsclc- unresolved chronic toxic effects from previous anticancer therapy
boolean
C0149925 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C0600688 (UMLS CUI [2,3])
gefitinib hypersensitivity
Item
2. known severe hypersensitivity to gefitinib or any of the tablet excipients
boolean
C1122962 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
swallow tablets
Item
3. inability to swallow tablets
boolean
C0566355 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
other malignancy
Item
4. other coexisting malignant disease (apart from basal-cell carcinoma)
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
prior chemotherapy for nsclc
Item
5. more than three previous chemotherapy regimens for nsclc
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
experimental drug egfr inhibitor
Item
6. previous treatment with an experimental agent of which the main mechanism of action is inhibition of epidermal growth factor receptor or its associated tyrosine kinase
boolean
C0304229 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])
phenytoin, carbamazepine, rifampicin, barbiturates, st johns wort, systemic disease, interstitial lung disease, pregnancy, breast feeding
Item
7. concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or st john's wort; severe or uncontrolled systemic disease; clinically active interstitial lung disease (except uncomplicated lymphangitic carcinomatosis) pregnancy; and breastfeeding.
boolean
C0031507 (UMLS CUI [1])
C0006949 (UMLS CUI [2])
C0035608 (UMLS CUI [3])
C0004745 (UMLS CUI [4])
C0936242 (UMLS CUI [5])
C0442893 (UMLS CUI [6])
C0206062 (UMLS CUI [7])
C0032961 (UMLS CUI [8])
C0006147 (UMLS CUI [9])
heart diseases
Item
8. mi within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia
boolean
C0018799 (UMLS CUI [1])
infections
Item
9. serious concomitant infection including post obstructive pneumonia
boolean
C0009450 (UMLS CUI [1])
major surgery
Item
10. major surgery other than biopsy within the past two weeks.
boolean
C0679637 (UMLS CUI [1])
pregnancy, breast feeding
Item
11. pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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