ID

37241

Beskrivning

Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02011594

Länk

https://clinicaltrials.gov/show/NCT02011594

Nyckelord

  1. 2019-07-11 2019-07-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 juli 2019

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Stage IV Esophageal Squamous Cell Carcinoma NCT02011594

Eligibility Stage IV Esophageal Squamous Cell Carcinoma NCT02011594

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient who was confirmed stage iv esophageal carcinoma by pathologic histology or cytology.
Beskrivning

Esophageal carcinoma TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0152018
UMLS CUI [1,2]
C3258246
the sample size estimate: 20 cases per arm.
Beskrivning

Specimen Size | Case Quantity Arm

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C1706256
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1522541
males or females aged ≥18 years, < 75 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status 0-2. life expectancy ≥12 weeks.
Beskrivning

ECOG performance status | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.
Beskrivning

Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
adequate bone marrow, renal, and liver function are required.
Beskrivning

Bone Marrow function | Renal function | Liver function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
Beskrivning

Protocol Compliance | Ability Receive Oral medication

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0175795
institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
Beskrivning

Systemic disease Unstable | Communicable Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Serious | Pharmaceutical Preparations Required | Liver disease | Kidney Disease | Metabolic Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0009450
UMLS CUI [3]
C1868885
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0018802
UMLS CUI [6]
C0027051
UMLS CUI [7,1]
C0003811
UMLS CUI [7,2]
C0205404
UMLS CUI [8,1]
C0013227
UMLS CUI [8,2]
C1514873
UMLS CUI [9]
C0023895
UMLS CUI [10]
C0022658
UMLS CUI [11]
C0025517
allergy to anti-egfr antibody.
Beskrivning

Hypersensitivity EGFR Antibody

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4055105
female subjects should not be pregnant or breast-feeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
adequate hematological function: absolute neutrophil count (anc) ≥1.5 x 109/l, and platelet count ≥100 x 109/l. adequate renal function: serum creatinine ≤ 1.5 x uln, or ≥ 50 ml/min. adequate liver function: total bilirubin < 1.5 x upper limit of normal (uln) and alanine aminotransferase (alt) and aspartate aminotransferase (ast) < 2.5 x uln in the absence of liver metastases, or < 5 x uln in case of liver metastases.
Beskrivning

Hematologic function | Absolute neutrophil count | Platelet Count measurement | Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0232804
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0232741
UMLS CUI [7]
C1278039
UMLS CUI [8]
C0201836
UMLS CUI [9]
C0201899
UMLS CUI [10,1]
C0494165
UMLS CUI [10,2]
C0332197
UMLS CUI [11]
C0494165
patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Beskrivning

Protocol Compliance Unable | Protocol Compliance Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080

Similar models

Eligibility Stage IV Esophageal Squamous Cell Carcinoma NCT02011594

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Esophageal carcinoma TNM clinical staging
Item
patient who was confirmed stage iv esophageal carcinoma by pathologic histology or cytology.
boolean
C0152018 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Specimen Size | Case Quantity Arm
Item
the sample size estimate: 20 cases per arm.
boolean
C0370003 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1706256 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1522541 (UMLS CUI [2,3])
Age
Item
males or females aged ≥18 years, < 75 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Life Expectancy
Item
eastern cooperative oncology group (ecog) performance status 0-2. life expectancy ≥12 weeks.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Contraceptive methods
Item
males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.
boolean
C0700589 (UMLS CUI [1])
Bone Marrow function | Renal function | Liver function
Item
adequate bone marrow, renal, and liver function are required.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Protocol Compliance | Ability Receive Oral medication
Item
able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
boolean
C0525058 (UMLS CUI [1])
C0085732 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
Informed Consent
Item
institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systemic disease Unstable | Communicable Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Serious | Pharmaceutical Preparations Required | Liver disease | Kidney Disease | Metabolic Disease
Item
any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
boolean
C0442893 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
C0003811 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
C0013227 (UMLS CUI [8,1])
C1514873 (UMLS CUI [8,2])
C0023895 (UMLS CUI [9])
C0022658 (UMLS CUI [10])
C0025517 (UMLS CUI [11])
Hypersensitivity EGFR Antibody
Item
allergy to anti-egfr antibody.
boolean
C0020517 (UMLS CUI [1,1])
C4055105 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
female subjects should not be pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver
Item
adequate hematological function: absolute neutrophil count (anc) ≥1.5 x 109/l, and platelet count ≥100 x 109/l. adequate renal function: serum creatinine ≤ 1.5 x uln, or ≥ 50 ml/min. adequate liver function: total bilirubin < 1.5 x upper limit of normal (uln) and alanine aminotransferase (alt) and aspartate aminotransferase (ast) < 2.5 x uln in the absence of liver metastases, or < 5 x uln in case of liver metastases.
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0232741 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C0201899 (UMLS CUI [9])
C0494165 (UMLS CUI [10,1])
C0332197 (UMLS CUI [10,2])
C0494165 (UMLS CUI [11])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])

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