ID

42786

Description

Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00113763

Lien

https://clinicaltrials.gov/show/NCT00113763

Mots-clés

Versions (2)
  1. 04/08/2016 04/08/2016 -
  2. 17/09/2021 17/09/2021 -
Téléchargé le

17 septembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00113763

Anglais

Eligibility Colorectal Cancer NCT00113763

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
Description

Adenocarcinoma of large intestine | biopsy tissue

Type de données

boolean

Alias
UMLS CUI [1]
C1319315
UMLS CUI [2]
C3864006
metastatic colorectal carcinoma
Description

Colorectal cancer metastatic

Type de données

boolean

Alias
UMLS CUI [1]
C0948380
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
Description

Disease Progression Evidence of | Therapeutic procedure | fluoropyrimidine | irinotecan | oxaliplatin | Chemotherapy Colorectal cancer metastatic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0087111
UMLS CUI [3]
C0596581
UMLS CUI [4]
C0123931
UMLS CUI [5]
C0069717
UMLS CUI [6,1]
C0392920
UMLS CUI [6,2]
C0948380
radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen
Description

Disease Progression | radiography | Chemotherapy

Type de données

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0034571
UMLS CUI [3]
C0392920
unidimensionally measurable disease
Description

Measurable Disease Dimension One

Type de données

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0439534
UMLS CUI [1,3]
C0205447
tumor expressing epidermal growth factor receptor (egfr) by immunohistochemistry
Description

Malignant Neoplasm | Epidermal Growth Factor Receptor Gene Expression | Immunohistochemistry

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0034802
UMLS CUI [2,2]
C0017262
UMLS CUI [3]
C0021044
at least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer
Description

Prior Chemotherapy Quantity Colorectal Cancer

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0009402
adequate hematologic, renal and hepatic function
Description

Hematologic function | Renal function | Liver function

Type de données

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
symptomatic brain metastases requiring treatment
Description

Metastatic malignant neoplasm to brain Symptomatic | Therapeutic procedure Requirement

Type de données

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1514873
history or evidence of interstitial pneumonitis or pulmonary fibrosis
Description

Interstitial Pneumonia History | Pulmonary Fibrosis History | Interstitial Pneumonia Evidence of | Pulmonary Fibrosis Evidence of

Type de données

boolean

Alias
UMLS CUI [1,1]
C0206061
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0034069
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0206061
UMLS CUI [3,2]
C0332120
UMLS CUI [4,1]
C0034069
UMLS CUI [4,2]
C0332120
use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment
Description

Systemic Chemotherapy | Therapeutic radiology procedure Systemic

Type de données

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205373
prior epidermal growth factor receptor (egfr) targeting therapies
Description

Prior Therapy Targeting Epidermal Growth Factor Receptor

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0034802
prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than a week) serum half life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment.
Description

cancer treatment | Investigational New Drugs | Small Molecule Against Malignant Neoplasms | Biological Factors drug biological half life Short | Proteins

Type de données

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C1328819
UMLS CUI [3,2]
C0521124
UMLS CUI [3,3]
C0006826
UMLS CUI [4,1]
C0005515
UMLS CUI [4,2]
C0599113
UMLS CUI [4,3]
C1806781
UMLS CUI [5]
C0033684
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Similar models

Eligibility Colorectal Cancer NCT00113763

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of large intestine | biopsy tissue
Item
pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
boolean
C1319315 (UMLS CUI [1])
C3864006 (UMLS CUI [2])
Colorectal cancer metastatic
Item
metastatic colorectal carcinoma
boolean
C0948380 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Disease Progression Evidence of | Therapeutic procedure | fluoropyrimidine | irinotecan | oxaliplatin | Chemotherapy Colorectal cancer metastatic
Item
documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
boolean
C0242656 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
C0596581 (UMLS CUI [3])
C0123931 (UMLS CUI [4])
C0069717 (UMLS CUI [5])
C0392920 (UMLS CUI [6,1])
C0948380 (UMLS CUI [6,2])
Disease Progression | radiography | Chemotherapy
Item
radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen
boolean
C0242656 (UMLS CUI [1])
C0034571 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
Measurable Disease Dimension One
Item
unidimensionally measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C0439534 (UMLS CUI [1,2])
C0205447 (UMLS CUI [1,3])
Malignant Neoplasm | Epidermal Growth Factor Receptor Gene Expression | Immunohistochemistry
Item
tumor expressing epidermal growth factor receptor (egfr) by immunohistochemistry
boolean
C0006826 (UMLS CUI [1])
C0034802 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0021044 (UMLS CUI [3])
Prior Chemotherapy Quantity Colorectal Cancer
Item
at least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0009402 (UMLS CUI [1,3])
Hematologic function | Renal function | Liver function
Item
adequate hematologic, renal and hepatic function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain Symptomatic | Therapeutic procedure Requirement
Item
symptomatic brain metastases requiring treatment
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Interstitial Pneumonia History | Pulmonary Fibrosis History | Interstitial Pneumonia Evidence of | Pulmonary Fibrosis Evidence of
Item
history or evidence of interstitial pneumonitis or pulmonary fibrosis
boolean
C0206061 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0034069 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0206061 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
C0034069 (UMLS CUI [4,1])
C0332120 (UMLS CUI [4,2])
Systemic Chemotherapy | Therapeutic radiology procedure Systemic
Item
use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment
boolean
C1883256 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
Prior Therapy Targeting Epidermal Growth Factor Receptor
Item
prior epidermal growth factor receptor (egfr) targeting therapies
boolean
C1514463 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0034802 (UMLS CUI [1,3])
cancer treatment | Investigational New Drugs | Small Molecule Against Malignant Neoplasms | Biological Factors drug biological half life Short | Proteins
Item
prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than a week) serum half life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment.
boolean
C0920425 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C1328819 (UMLS CUI [3,1])
C0521124 (UMLS CUI [3,2])
C0006826 (UMLS CUI [3,3])
C0005515 (UMLS CUI [4,1])
C0599113 (UMLS CUI [4,2])
C1806781 (UMLS CUI [4,3])
C0033684 (UMLS CUI [5])
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