ID

16758

Beschreibung

Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00083616

Link

https://clinicaltrials.gov/show/NCT00083616

Stichworte

Versionen (3)
  1. 04.08.16 04.08.16 -
  2. 04.08.16 04.08.16 -
  3. 04.08.16 04.08.16 -
Hochgeladen am

4. August 2016

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Colorectal Cancer NCT00083616

Englisch

Eligibility Colorectal Cancer NCT00083616

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Adenocarcinoma of large intestine | biopsy tissue

Datentyp

boolean

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

Colorectal cancer metastatic

Datentyp

boolean

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

ECOG performance status

Datentyp

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
Beschreibung

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

Datentyp

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 is required
Beschreibung

Disease Progression | radiography | Chemotherapy Requirement

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0034571
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1514873
bidimensionally measurable disease
Beschreibung

Measurable Disease 2-Dimensional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
tumor expressing epidermal growth factor receptor (egfr) by immunohistochemistry
Beschreibung

Malignant Neoplasm | Epidermal Growth Factor Receptor Gene Expression | Immunohistochemistry

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0034802
UMLS CUI [2,2]
C0017262
UMLS CUI [3]
C0021044
at least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal cancer
Beschreibung

Prior Chemotherapy Quantity Colorectal cancer metastatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0948380
adequate hematologic, renal and hepatic function
Beschreibung

Hematologic function | Renal function | Liver function

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
symptomatic brain metastases requiring treatment
Beschreibung

Metastatic malignant neoplasm to brain Symptomatic | Requirement Therapeutic procedure

Datentyp

boolean

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

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

Datentyp

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 before enrollment
Beschreibung

Systemic Chemotherapy | Therapeutic radiology procedure Systemic

Datentyp

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205373
prior epidermal growth factor receptor targeting agents
Beschreibung

Pharmaceutical Preparations Targeting Epidermal Growth Factor Receptor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
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 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins with longer serum half-life (e.g., avastintm) within 6 weeks before enrollment
Beschreibung

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

Datentyp

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 [5,1]
C0033684
UMLS CUI [5,2]
C0599113
UMLS CUI [5,3]
C0205166
UMLS CUI [6]
C1135130
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Ähnliche Modelle

Eligibility Colorectal Cancer NCT00083616

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 Requirement
Item
radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen is required
boolean
C0242656 (UMLS CUI [1])
C0034571 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Measurable Disease 2-Dimensional
Item
bidimensionally measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
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 metastatic
Item
at least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal cancer
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0948380 (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 | Requirement Therapeutic procedure
Item
symptomatic brain metastases requiring treatment
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Interstitial Pneumonia History | Pulmonary Fibrosis History | Interstitial Pneumonia Evidence of | Pulmonary Fibrosis Evidence of
Item
patient with a history of interstitial pneumonitis or pulmonary fibrosis 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 before enrollment
boolean
C1883256 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
Pharmaceutical Preparations Targeting Epidermal Growth Factor Receptor
Item
prior epidermal growth factor receptor targeting agents
boolean
C0013227 (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 drug biological half life Long | Avastin
Item
prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins with longer serum half-life (e.g., avastintm) within 6 weeks 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 [5,1])
C0599113 (UMLS CUI [5,2])
C0205166 (UMLS CUI [5,3])
C1135130 (UMLS CUI [6])
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