ID

24623

Descripción

Panitumumab Plus FOLFIRI in First-line Treatment of Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00508404

Link

https://clinicaltrials.gov/show/NCT00508404

Palabras clave

Versiones (1)
  1. 9/8/17 9/8/17 -
Subido en

9 de agosto de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT00508404

Inglés

Eligibility Metastatic Colorectal Cancer NCT00508404

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with histologically- or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum.
Descripción

COLON ADENOCARCINOMA METASTATIC | Adenocarcinoma of rectum metastatic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0742581
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1522484
measurable disease according to modified recist guidelines.
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
paraffin-embedded tissue or unstained tumour slides from primary or metastatic tumour available for central lab analysis.
Descripción

Primary tumor Paraffin Embedded Tissue Available | Neoplasm Metastasis Paraffin Embedded Tissue Available | Primary tumor Unstained Specimen Available | Neoplasm Metastasis Unstained Specimen Available

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1519524
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1519524
UMLS CUI [2,3]
C0470187
UMLS CUI [3,1]
C0677930
UMLS CUI [3,2]
C1883469
UMLS CUI [3,3]
C0470187
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C1883469
UMLS CUI [4,3]
C0470187
adequate haematologic, renal, hepatic and metabolic function.
Descripción

Hematologic function | Renal function | Liver function | Metabolic function normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0438212
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
central nervous system metastases.
Descripción

CNS metastases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0686377
prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to initiating study treatment.
Descripción

Systemic therapy Colorectal cancer metastatic | Exception Adjuvant Chemotherapy Fluoropyrimidine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0948380
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0085533
UMLS CUI [2,3]
C0596581
prior anti-egfr antibody therapy (e.g.: cetuximab) or treatment with small molecule egfr tyrosine kinase inhibitors (e.g.: erlotinib).
Descripción

EGFR Antibody Therapeutic procedure | cetuximab | Small Molecule EGFR Tyrosine Kinase Inhibitor Therapy | erlotinib

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4055105
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C0995188
UMLS CUI [3,1]
C1328819
UMLS CUI [3,2]
C3899317
UMLS CUI [4]
C1135135
prior radiotherapy within 14 days prior to screening, and for which all signs of early radiological toxicity have not abated.
Descripción

Therapeutic radiology procedure | Toxicity Signs Abate Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0311392
UMLS CUI [2,3]
C3853704
UMLS CUI [2,4]
C0332268
significant cardiovascular disease including unstable angina or myocardial infarction within six months before initiating study treatment or a history of ventricular arrhythmia.
Descripción

Cardiovascular Diseases | Angina, Unstable | Myocardial Infarction | Ventricular arrhythmia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0085612
history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest ct scan.
Descripción

Interstitial Pneumonitis | Pulmonary Fibrosis | Chest CT

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206061
UMLS CUI [2]
C0034069
UMLS CUI [3]
C0202823
active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).
Descripción

Inflammatory Bowel Disease Causing Chronic diarrhea | Intestinal Disease Causing Chronic diarrhea | Loose stool Quantity per day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021390
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0401151
UMLS CUI [2,1]
C0021831
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0401151
UMLS CUI [3,1]
C2129214
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0439505
history of gilbert's syndrome or dihydropyrimidine deficiency.
Descripción

Gilbert Disease | Dihydropyrimidine Dehydrogenase Deficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017551
UMLS CUI [2]
C1959620
known positive test for human immunodeficiency virus infection, hepatitis c virus, chronic active hepatitis b infection.
Descripción

HIV Seropositivity | Hepatitis C positive | Chronic active hepatitis B

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C1112419
UMLS CUI [3]
C0744831
any investigational agent within 30 days before initiation of study treatment.
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
must not have had a major surgical procedure within 28 days prior to initiation of study treatment.
Descripción

major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
subject who is pregnant or breast-feeding.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for six months after the last study drug administration for women, and one month for men.
Descripción

Childbearing Potential Contraceptive methods Unwilling | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2]
C0079399
other protocol specified criteria and specific details may apply.
Descripción

Clinical Trial Eligibility Criteria Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Metastatic Colorectal Cancer NCT00508404

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
COLON ADENOCARCINOMA METASTATIC | Adenocarcinoma of rectum metastatic
Item
diagnosed with histologically- or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum.
boolean
C0742581 (UMLS CUI [1])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Measurable Disease
Item
measurable disease according to modified recist guidelines.
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2.
boolean
C1520224 (UMLS CUI [1])
Primary tumor Paraffin Embedded Tissue Available | Neoplasm Metastasis Paraffin Embedded Tissue Available | Primary tumor Unstained Specimen Available | Neoplasm Metastasis Unstained Specimen Available
Item
paraffin-embedded tissue or unstained tumour slides from primary or metastatic tumour available for central lab analysis.
boolean
C0677930 (UMLS CUI [1,1])
C1519524 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C1519524 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
C0677930 (UMLS CUI [3,1])
C1883469 (UMLS CUI [3,2])
C0470187 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C1883469 (UMLS CUI [4,2])
C0470187 (UMLS CUI [4,3])
Hematologic function | Renal function | Liver function | Metabolic function normal
Item
adequate haematologic, renal, hepatic and metabolic function.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0438212 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
CNS metastases
Item
central nervous system metastases.
boolean
C0686377 (UMLS CUI [1])
Systemic therapy Colorectal cancer metastatic | Exception Adjuvant Chemotherapy Fluoropyrimidine
Item
prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to initiating study treatment.
boolean
C1515119 (UMLS CUI [1,1])
C0948380 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0085533 (UMLS CUI [2,2])
C0596581 (UMLS CUI [2,3])
EGFR Antibody Therapeutic procedure | cetuximab | Small Molecule EGFR Tyrosine Kinase Inhibitor Therapy | erlotinib
Item
prior anti-egfr antibody therapy (e.g.: cetuximab) or treatment with small molecule egfr tyrosine kinase inhibitors (e.g.: erlotinib).
boolean
C4055105 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0995188 (UMLS CUI [2])
C1328819 (UMLS CUI [3,1])
C3899317 (UMLS CUI [3,2])
C1135135 (UMLS CUI [4])
Therapeutic radiology procedure | Toxicity Signs Abate Lacking
Item
prior radiotherapy within 14 days prior to screening, and for which all signs of early radiological toxicity have not abated.
boolean
C1522449 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0311392 (UMLS CUI [2,2])
C3853704 (UMLS CUI [2,3])
C0332268 (UMLS CUI [2,4])
Cardiovascular Diseases | Angina, Unstable | Myocardial Infarction | Ventricular arrhythmia
Item
significant cardiovascular disease including unstable angina or myocardial infarction within six months before initiating study treatment or a history of ventricular arrhythmia.
boolean
C0007222 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0085612 (UMLS CUI [4])
Interstitial Pneumonitis | Pulmonary Fibrosis | Chest CT
Item
history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest ct scan.
boolean
C0206061 (UMLS CUI [1])
C0034069 (UMLS CUI [2])
C0202823 (UMLS CUI [3])
Inflammatory Bowel Disease Causing Chronic diarrhea | Intestinal Disease Causing Chronic diarrhea | Loose stool Quantity per day
Item
active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).
boolean
C0021390 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0401151 (UMLS CUI [1,3])
C0021831 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0401151 (UMLS CUI [2,3])
C2129214 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0439505 (UMLS CUI [3,3])
Gilbert Disease | Dihydropyrimidine Dehydrogenase Deficiency
Item
history of gilbert's syndrome or dihydropyrimidine deficiency.
boolean
C0017551 (UMLS CUI [1])
C1959620 (UMLS CUI [2])
HIV Seropositivity | Hepatitis C positive | Chronic active hepatitis B
Item
known positive test for human immunodeficiency virus infection, hepatitis c virus, chronic active hepatitis b infection.
boolean
C0019699 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0744831 (UMLS CUI [3])
Investigational New Drugs
Item
any investigational agent within 30 days before initiation of study treatment.
boolean
C0013230 (UMLS CUI [1])
major surgery
Item
must not have had a major surgical procedure within 28 days prior to initiation of study treatment.
boolean
C0679637 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
subject who is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling | Gender
Item
woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for six months after the last study drug administration for women, and one month for men.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol specified criteria and specific details may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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