ID

20227

Beskrivning

Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01564810

Länk

https://clinicaltrials.gov/show/NCT01564810

Nyckelord

Versioner (1)
  1. 2017-02-15 2017-02-15 -
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15 februari 2017

DOI

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Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT01564810

Engelsk

Eligibility Colorectal Neoplasms NCT01564810

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥ 18 and ≤ 75 years;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. primary tumour has undergone radical resection and histologically confirmed colorectal adenocarcinoma;
Beskrivning

Primary tumor Radical excision | Adenocarcinoma of large intestine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0184918
UMLS CUI [2]
C1319315
3. together with clinical or radiological evidence of first occurrence of non-resectable synchronous liver-only metastases
Beskrivning

Secondary malignant neoplasm of liver Synchronous unresectable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0494165
UMLS CUI [1,2]
C0439580
UMLS CUI [1,3]
C1519810
4. with evidence of tumor egfr expression and kras gene wild-type status;
Beskrivning

Epidermal Growth Factor Receptor Expression Neoplasm Evidence of | KRAS gene Wild Type

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C0017262
UMLS CUI [1,3]
C0027651
UMLS CUI [1,4]
C0332120
UMLS CUI [2,1]
C1537502
UMLS CUI [2,2]
C1883559
5. with one measurable tumor.
Beskrivning

Measurable Disease Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
6. performance status (ecog) 0~1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
7. a life expectancy of ≥ 3 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
8. adequate hematological function: neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hb ≥9g/dl (within 1 week prior to randomization)
Beskrivning

Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
9. adequate hepatic and renal function: serum bilirubin≤1.5 x upper limit of normal (uln), alkaline phosphatase ≤5x uln, and serum transaminase (either ast or alt) ≤ 5 x uln(within 1 week prior to randomization);
Beskrivning

Liver function | Renal function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201850
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
10. written informed consent for participation in the trial.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous exposure to target therapy, chemotherapy, radiotherapy or intervention therapy for colorectal liver metastases.
Beskrivning

Targeted Therapy Secondary malignant neoplasm of liver Colorectal | Chemotherapy Secondary malignant neoplasm of liver Colorectal | Therapeutic radiology procedure Secondary malignant neoplasm of liver Colorectal | Therapeutic Intervention Secondary malignant neoplasm of liver Colorectal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C0494165
UMLS CUI [1,3]
C0555952
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0494165
UMLS CUI [2,3]
C0555952
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0494165
UMLS CUI [3,3]
C0555952
UMLS CUI [4,1]
C0808232
UMLS CUI [4,2]
C0494165
UMLS CUI [4,3]
C0555952
2. known or suspected extrahepatic metastases.
Beskrivning

Neoplasm Metastasis Extrahepatic | Neoplasm Metastasis Extrahepatic Suspected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1517058
UMLS CUI [2,3]
C0750491
3. patients with known hypersensitivity reactions to any of the components of the study treatments.
Beskrivning

Hypersensitivity Investigational therapy Component

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0949266
UMLS CUI [1,3]
C1705248
4. having previously participated in a study which included a possibility of being allocated to cetuximab therapy (whether or not the patient actually received cetuximab)
Beskrivning

Study Subject Participation Status | Cetuximab Possible

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0995188
UMLS CUI [2,2]
C0332149
5. clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or left ventricular ejection fraction (lvef) below the institutional range of normal
Beskrivning

Coronary Artery Disease | Myocardial Infarction | Left ventricular ejection fraction Decrease

Datatyp

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0428772
UMLS CUI [3,2]
C0547047
6. acute or sub-acute intestinal occlusion
Beskrivning

Intestinal Obstruction | Intestinal Obstruction Subacute

Datatyp

boolean

Alias
UMLS CUI [1]
C0021843
UMLS CUI [2,1]
C0021843
UMLS CUI [2,2]
C0205365
7. pregnancy (absence confirmed by serum/urine β-hcg) or breast-feeding
Beskrivning

Pregnancy Serum pregnancy test | Pregnancy Urine human chorionic gonadotropin measurement | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0430064
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C2188702
UMLS CUI [3]
C0006147
8. other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
Beskrivning

Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0851140
9. known drug abuse/ alcohol abuse
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
10. legal incapacity or limited legal capacity
Beskrivning

Incapacity Legal | Legal capacity Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3176592
UMLS CUI [1,2]
C1301860
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0439801
11. pre-existing peripheral neuropathy.
Beskrivning

Peripheral Neuropathy Pre-existing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
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Similar models

Eligibility Colorectal Neoplasms NCT01564810

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≥ 18 and ≤ 75 years;
boolean
C0001779 (UMLS CUI [1])
Primary tumor Radical excision | Adenocarcinoma of large intestine
Item
2. primary tumour has undergone radical resection and histologically confirmed colorectal adenocarcinoma;
boolean
C0677930 (UMLS CUI [1,1])
C0184918 (UMLS CUI [1,2])
C1319315 (UMLS CUI [2])
Secondary malignant neoplasm of liver Synchronous unresectable
Item
3. together with clinical or radiological evidence of first occurrence of non-resectable synchronous liver-only metastases
boolean
C0494165 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
C1519810 (UMLS CUI [1,3])
Epidermal Growth Factor Receptor Expression Neoplasm Evidence of | KRAS gene Wild Type
Item
4. with evidence of tumor egfr expression and kras gene wild-type status;
boolean
C0034802 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C0332120 (UMLS CUI [1,4])
C1537502 (UMLS CUI [2,1])
C1883559 (UMLS CUI [2,2])
Measurable Disease Quantity
Item
5. with one measurable tumor.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
6. performance status (ecog) 0~1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
7. a life expectancy of ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
8. adequate hematological function: neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hb ≥9g/dl (within 1 week prior to randomization)
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver function | Renal function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
9. adequate hepatic and renal function: serum bilirubin≤1.5 x upper limit of normal (uln), alkaline phosphatase ≤5x uln, and serum transaminase (either ast or alt) ≤ 5 x uln(within 1 week prior to randomization);
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
Informed Consent
Item
10. written informed consent for participation in the trial.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Targeted Therapy Secondary malignant neoplasm of liver Colorectal | Chemotherapy Secondary malignant neoplasm of liver Colorectal | Therapeutic radiology procedure Secondary malignant neoplasm of liver Colorectal | Therapeutic Intervention Secondary malignant neoplasm of liver Colorectal
Item
1. previous exposure to target therapy, chemotherapy, radiotherapy or intervention therapy for colorectal liver metastases.
boolean
C2985566 (UMLS CUI [1,1])
C0494165 (UMLS CUI [1,2])
C0555952 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0494165 (UMLS CUI [2,2])
C0555952 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
C0555952 (UMLS CUI [3,3])
C0808232 (UMLS CUI [4,1])
C0494165 (UMLS CUI [4,2])
C0555952 (UMLS CUI [4,3])
Neoplasm Metastasis Extrahepatic | Neoplasm Metastasis Extrahepatic Suspected
Item
2. known or suspected extrahepatic metastases.
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C1517058 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
Hypersensitivity Investigational therapy Component
Item
3. patients with known hypersensitivity reactions to any of the components of the study treatments.
boolean
C0020517 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Study Subject Participation Status | Cetuximab Possible
Item
4. having previously participated in a study which included a possibility of being allocated to cetuximab therapy (whether or not the patient actually received cetuximab)
boolean
C2348568 (UMLS CUI [1])
C0995188 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
Coronary Artery Disease | Myocardial Infarction | Left ventricular ejection fraction Decrease
Item
5. clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or left ventricular ejection fraction (lvef) below the institutional range of normal
boolean
C1956346 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0428772 (UMLS CUI [3,1])
C0547047 (UMLS CUI [3,2])
Intestinal Obstruction | Intestinal Obstruction Subacute
Item
6. acute or sub-acute intestinal occlusion
boolean
C0021843 (UMLS CUI [1])
C0021843 (UMLS CUI [2,1])
C0205365 (UMLS CUI [2,2])
Pregnancy Serum pregnancy test | Pregnancy Urine human chorionic gonadotropin measurement | Breast Feeding
Item
7. pregnancy (absence confirmed by serum/urine β-hcg) or breast-feeding
boolean
C0032961 (UMLS CUI [1,1])
C0430064 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C2188702 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
8. other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Substance Use Disorders
Item
9. known drug abuse/ alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Incapacity Legal | Legal capacity Limited
Item
10. legal incapacity or limited legal capacity
boolean
C3176592 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Peripheral Neuropathy Pre-existing
Item
11. pre-existing peripheral neuropathy.
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
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