ID

22180

Descrizione

UFUR (Tegafur/Uracil) Plus Iressa in Non-small-cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01037998

collegamento

https://clinicaltrials.gov/show/NCT01037998

Keywords

versioni (1)
  1. 22/05/17 22/05/17 -
Caricato su

22 maggio 2017

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Non-Small-Cell Lung Cancer NCT01037998

Inglese

Eligibility Non-Small-Cell Lung Cancer NCT01037998

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytological diagnosis of nsclc who failed previous platinum-based and taxanes chemotherapy.
Descrizione

Non-Small Cell Lung Carcinoma | Chemotherapy Platinum Based failed | Chemotherapy taxane failed

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0032207
UMLS CUI [2,3]
C1705938
UMLS CUI [2,4]
C0231175
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0215136
UMLS CUI [3,3]
C0231175
no prior radiotherapy on measurable lesion(s).
Descrizione

Measurable lesion Prior radiation therapy Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0279134
UMLS CUI [1,3]
C0332197
performance status of 0 to 3 on the zubrod scale. (reference 1)
Descrizione

Zubrod Performance Status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3714786
clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical examination. lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by ct scan, mri, or chest x-ray.
Descrizione

Measurable Disease 2-Dimensional | Margin Well defined X-Ray | Margin Well defined Scan | Margin Well defined Physical Examination | Lesion size X-Ray Computed Tomography | Lesion size MRI | Lesion size Plain chest X-ray

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [2,1]
C0205284
UMLS CUI [2,2]
C0442825
UMLS CUI [2,3]
C0034571
UMLS CUI [3,1]
C0205284
UMLS CUI [3,2]
C0442825
UMLS CUI [3,3]
C0441633
UMLS CUI [4,1]
C0205284
UMLS CUI [4,2]
C0442825
UMLS CUI [4,3]
C0031809
UMLS CUI [5,1]
C0449453
UMLS CUI [5,2]
C0040405
UMLS CUI [6,1]
C0449453
UMLS CUI [6,2]
C0024485
UMLS CUI [7,1]
C0449453
UMLS CUI [7,2]
C0039985
informed consent from patient.
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
males or females 18 years of age or older.
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
if female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device [iud], birth control pills, or barrier device) during and for three months after trial.
Descrizione

Childbearing Potential Ended | Operative Surgical Procedures | Radiation | Menopause | Childbearing Potential Contraceptive methods | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C1272693
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0851346
UMLS CUI [4]
C0025320
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0700589
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0009905
UMLS CUI [8]
C0004764
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection (at the discretion of the investigator).
Descrizione

Communicable Disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009450
inadequate liver function (total bilirubin >1.5 times above normal range); alanine transaminase (alt) and aspartate transaminase (ast) greater than 5 times normal.
Descrizione

Liver Dysfunction | Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
inadequate renal function (creatinine >2.0 mg/dl).
Descrizione

Abnormal renal function | Creatinine measurement, serum

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2]
C0201976
breast feeding.
Descrizione

Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006147
second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
Descrizione

Second Primary Cancers | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2]
C0851140
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
concomitant myelosuppressive radiotherapy, chemotherapy, hormonal therapy, or immunotherapy will not be allowed except as for palliative radiation to non-measurable lesion.
Descrizione

Therapeutic radiology procedure Myelosuppression | Chemotherapy | Hormone Therapy | Immunotherapy | Palliative Radiation Therapy Non-Measurable Lesion

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0854467
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0021083
UMLS CUI [5,1]
C3898008
UMLS CUI [5,2]
C1334988
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Similar models

Eligibility Non-Small-Cell Lung Cancer NCT01037998

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | Chemotherapy Platinum Based failed | Chemotherapy taxane failed
Item
histologic or cytological diagnosis of nsclc who failed previous platinum-based and taxanes chemotherapy.
boolean
C0007131 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0032207 (UMLS CUI [2,2])
C1705938 (UMLS CUI [2,3])
C0231175 (UMLS CUI [2,4])
C0392920 (UMLS CUI [3,1])
C0215136 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
Measurable lesion Prior radiation therapy Absent
Item
no prior radiotherapy on measurable lesion(s).
boolean
C1513041 (UMLS CUI [1,1])
C0279134 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Zubrod Performance Status
Item
performance status of 0 to 3 on the zubrod scale. (reference 1)
boolean
C3714786 (UMLS CUI [1])
Measurable Disease 2-Dimensional | Margin Well defined X-Ray | Margin Well defined Scan | Margin Well defined Physical Examination | Lesion size X-Ray Computed Tomography | Lesion size MRI | Lesion size Plain chest X-ray
Item
clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical examination. lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by ct scan, mri, or chest x-ray.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0205284 (UMLS CUI [2,1])
C0442825 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
C0205284 (UMLS CUI [3,1])
C0442825 (UMLS CUI [3,2])
C0441633 (UMLS CUI [3,3])
C0205284 (UMLS CUI [4,1])
C0442825 (UMLS CUI [4,2])
C0031809 (UMLS CUI [4,3])
C0449453 (UMLS CUI [5,1])
C0040405 (UMLS CUI [5,2])
C0449453 (UMLS CUI [6,1])
C0024485 (UMLS CUI [6,2])
C0449453 (UMLS CUI [7,1])
C0039985 (UMLS CUI [7,2])
Informed Consent
Item
informed consent from patient.
boolean
C0021430 (UMLS CUI [1])
Age
Item
males or females 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Ended | Operative Surgical Procedures | Radiation | Menopause | Childbearing Potential Contraceptive methods | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier
Item
if female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device [iud], birth control pills, or barrier device) during and for three months after trial.
boolean
C3831118 (UMLS CUI [1,1])
C1272693 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C0851346 (UMLS CUI [3])
C0025320 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0021900 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C0004764 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Communicable Disease
Item
active infection (at the discretion of the investigator).
boolean
C0009450 (UMLS CUI [1])
Liver Dysfunction | Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
inadequate liver function (total bilirubin >1.5 times above normal range); alanine transaminase (alt) and aspartate transaminase (ast) greater than 5 times normal.
boolean
C0086565 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
Abnormal renal function | Creatinine measurement, serum
Item
inadequate renal function (creatinine >2.0 mg/dl).
boolean
C0151746 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Breast Feeding
Item
breast feeding.
boolean
C0006147 (UMLS CUI [1])
Second Primary Cancers | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated
Item
second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
boolean
C0751623 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
Therapeutic radiology procedure Myelosuppression | Chemotherapy | Hormone Therapy | Immunotherapy | Palliative Radiation Therapy Non-Measurable Lesion
Item
concomitant myelosuppressive radiotherapy, chemotherapy, hormonal therapy, or immunotherapy will not be allowed except as for palliative radiation to non-measurable lesion.
boolean
C1522449 (UMLS CUI [1,1])
C0854467 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C3898008 (UMLS CUI [5,1])
C1334988 (UMLS CUI [5,2])
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