ID

22180

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01037998

Nyckelord

Versioner (1)
  1. 2017-05-22 2017-05-22 -
Uppladdad den

22 maj 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Non-Small-Cell Lung Cancer NCT01037998

Engelsk

Eligibility Non-Small-Cell Lung Cancer NCT01037998

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

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

Datatyp

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).
Beskrivning

Measurable lesion Prior radiation therapy Absent

Datatyp

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)
Beskrivning

Zubrod Performance Status

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Informed Consent

Datatyp

boolean

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

Age

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Exclusion Criteria

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

Communicable Disease

Datatyp

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.
Beskrivning

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

Datatyp

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).
Beskrivning

Abnormal renal function | Creatinine measurement, serum

Datatyp

boolean

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

Breast Feeding

Datatyp

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)
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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
Tillbaka till toppen

Similar models

Eligibility Non-Small-Cell Lung Cancer NCT01037998

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial